risankizumab: package leaflet

Skyrizi contains the active substance risankizumab.

Skyrizi is used to treat the following inflammatory diseases:

• Plaque psoriasis in adults
• Plaque psoriasis in children and adolescents from 6 to less than 18 years of age
• Psoriatic arthritis in adults

How Skyrizi works
This medicine works by stopping a protein in the body called ‘IL-23’, which causes inflammation.

Plaque psoriasis in adults
Skyrizi is used to treat adults with moderate to severe plaque psoriasis. Skyrizi reduces inflammation and can therefore help reduce symptoms of plaque psoriasis such as burning, itching, pain, redness, and scaling.

Plaque psoriasis in children and adolescents
Skyrizi is used to treat children and adolescents from 6 to less than 18 years of age with moderate to severe plaque psoriasis. Skyrizi reduces inflammation and can therefore help reduce symptoms of plaque psoriasis such as burning, itching, pain, redness, and scaling.

Psoriatic arthritis
Skyrizi is used to treat adults with psoriatic arthritis. Psoriatic arthritis is a disease that causes inflamed joints and psoriasis. If you have active psoriatic arthritis, you may first be given other medicines. If

these medicines do not work well enough, you will be given Skyrizi either alone or in combination with other medicines to treat your psoriatic arthritis.

Skyrizi reduces inflammation and can therefore help to reduce pain, stiffness, and swelling in and around your joints, pain and stiffness in your spine, psoriatic skin rash, psoriatic nail damage, and it may slow down damage to the bone and cartilage in your joints. These effects can ease your normal daily activities, reduce tiredness, and improve your quality of life.

Do not use Skyrizi
- if you are allergic to risankizumab or any of the other ingredients of this medicine (listed in section 6).
- if you have an infection, including active tuberculosis, which your doctor thinks is important.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before and during the use of Skyrizi:
- if you currently have an infection or if you have an infection that keeps coming back.
- if you have tuberculosis (TB).
- if you have recently received or plan to receive an immunisation (vaccine). You should not be given certain types of vaccines while using Skyrizi.

It is important to keep a record of the batch number of your Skyrizi.
Every time you get a new pack of Skyrizi, note down the date and the batch number (which is on the packaging after “Lot”) and keep this information in a safe place.

Serious allergic reactions
Skyrizi can cause serious side effects, including serious allergic reactions (‘anaphylaxis’).
Tell your doctor or seek medical help immediately if you notice any signs of an allergic reaction while you are taking Skyrizi such as:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- low blood pressure, which can cause dizziness or light-headedness
- severe itching of the skin, with a red rash or raised bumps

Children and adolescents
Skyrizi is not recommended for children under 6 years of age with plaque psoriasis.

Skyrizi is not recommended for children and adolescents under 18 years of age with psoriatic arthritis.
This is because Skyrizi has not been studied in this age group.

Other medicines and Skyrizi
Tell your doctor, pharmacist or nurse:
- if you are using, have recently used or might use any other medicines.
- if you have recently had or are going to have a vaccination. You should not be given certain types of vaccines while using Skyrizi.

If you are not sure, talk to your doctor, pharmacist or nurse before and during the use of Skyrizi.

Pregnancy, contraception and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. This is because it is not known how this medicine will affect the baby.

If you are a woman who can become pregnant, you should use contraception while using this medicine and for at least 21 weeks after your last dose of Skyrizi.

If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine.

Driving and using machines
Skyrizi is not likely to affect your driving and use of machines.

Skyrizi contains polysorbate and sodium
This medicine contains 0.2 mg of polysorbate 20 in each 150 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

This medicine contains less than 1 mmol sodium (23 mg) per pre-filled pen, that is to say essentially ‘sodium-free’.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

This medicine is given as an injection under your skin (called a ‘subcutaneous injection’).

How much Skyrizi to use

Plaque psoriasis in adults
Adults

How much and how often to take?
Each dose is 150 mg given as a single injection.

After the first dose, you will have the next dose
4 weeks later, and then every 12 weeks.

Plaque psoriasis in children and adolescents
Age and body weight
How much and how often to take?
Children and adolescents 6 to less than
18 years of age weighing at least 40 kg
Each dose is 150 mg given as a single injection.

After the first dose, you will have the next dose
4 weeks later, and then every 12 weeks.
Children and adolescents 6 to less than
18 years of age weighing less than 40 kg
Each dose is 55 mg given as a single injection.
A 55 mg pre-filled syringe is available.

After the first dose, you will have the next dose
4 weeks later, and then every 12 weeks.

Psoriatic arthritis in adults
Adults

How much and how often to take?
Each dose is 150 mg given as a single injection.

After the first dose, you will have the next dose
4 weeks later, and then every 12 weeks.
You and your doctor, pharmacist or nurse will decide if you should inject this medicine yourself. Do not inject yourself with this medicine unless you have been trained by your doctor, pharmacist or nurse. A caregiver may also give your injection after they have been trained.

Read section 7 ‘Instructions for use’ at the end of this leaflet before injecting Skyrizi yourself.

If you use more Skyrizi than you should
If you have used more Skyrizi than you should or the dose has been given sooner than prescribed, talk to your doctor.

If you forget to use Skyrizi
If you forget to use Skyrizi, inject a dose as soon as you remember. Talk to your doctor if you are not sure what to do.

If you stop using Skyrizi
Do not stop using Skyrizi without talking to your doctor first. If you stop treatment, your symptoms may come back.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Allergic reactions – these may need urgent treatment. Tell your doctor or get emergency medical help straight away if you notice any of the following signs:

Serious allergic reactions (‘anaphylaxis’) are rare in people taking Skyrizi (may affect up to 1 in a 1 000 people). Signs include:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- low blood pressure, which can cause dizziness or light-headedness

Talk to your doctor or get medical help immediately if you have the following symptoms.
Symptoms of a serious infection such as:
- fever, flu-like symptoms, night sweats
- feeling tired or short of breath, cough which will not go away
- warm, red and painful skin, or a painful skin rash with blisters

Your doctor will decide if you can keep using Skyrizi.

Other side effects
Tell your doctor, pharmacist or nurse if you get any of the following side effects

Very common: may affect more than 1 in 10 people
- upper respiratory infections with symptoms such as sore throat and stuffy nose

Common: may affect up to 1 in 10 people
- feeling tired
- fungal skin infection
- injection site reactions (such as redness or pain)
- itching
- headache
- rash
- eczema

Uncommon: may affect up to 1 in 100 people
- small raised red bumps on the skin
- hives (urticaria)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pen label and outer carton after ‘EXP’.

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled pen in the outer carton in order to protect from light.

If needed, you may also store the pre-filled pen out of the refrigerator (up to a maximum of 25°C) for up to 24 hours in the original carton to protect from light.

Do not use this medicine if the liquid is cloudy or contains flakes or large particles.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Skyrizi contains
- The active substance is risankizumab. Each pre-filled pen contains 150 mg of risankizumab in 1 mL solution.
- The other ingredients are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20 and water for injections. See section 2, "Skyrizi contains polysorbate and sodium".

What Skyrizi looks like and contents of the pack
Skyrizi is a clear and colourless to yellow liquid in a pre-filled pen. The liquid may contain tiny white or clear particles.

Each pack contains 1 pre-filled pen.

Marketing Authorisation Holder and Manufacturer

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811
Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел: +359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel: +36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. z o.o.
Tel: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o.
Tel: +385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: +357 22 34 74 40

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu/

Detailed information on this product is also available by scanning the QR code included below or on the outer carton with a smartphone. The same information is available at the following URL:
www.skyrizi.eu

QR code to be included

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.

7.
Instructions for use

Please read all of section 7 before using Skyrizi

Skyrizi pre-filled pen

Dark grey cap
(Do not remove
Green activator button Inspection window Needle until ready to inject)

Grey hand grips White needle sleeve

Important information to know before you inject Skyrizi
- You should receive training on how to inject Skyrizi before giving an injection. Talk to your doctor, pharmacist or nurse if you need help
- In children and adolescents 10 to less than 18 years of age, it is recommended that Skyrizi is given by or under supervision of an adult.
- In children 6 to less than 10 years of age, Skyrizi should be given by an adult.

• Mark the dates on your calendar so you know when to inject Skyrizi
• Keep Skyrizi in the original carton to protect the medicine from light until it is time to use it
• Take the carton out of the refrigerator and leave it at room temperature, out of direct sunlight, for 30 to 90 minutes before injecting
• Do not inject if the liquid in the inspection window is cloudy or contains flakes or large particles. The liquid should look clear to yellow and may contain tiny white or clear particles
• Do not shake the pen
• Wait to remove the dark grey cap until just before the injection

Return this medicine to the pharmacy
- if the expiry date (EXP) has passed
- if the liquid has ever been frozen (even if thawed)
- if the pen has been dropped or damaged
- if the carton perforations are broken

Follow the steps below each time you use Skyrizi

STEP 1

Take the carton out of the refrigerator and leave it at room temperature, out of direct sunlight, for 30 to 90 minutes before injecting.
- Do not remove the pen from the carton while allowing Skyrizi to reach room temperature
- Do not warm Skyrizi in any other way. For example, do not warm it in a microwave or in hot water
- Do not use the pen if liquid has been frozen, even if it has been thawed
STEP 2

Place the following items on a clean, flat surface:
- 1 pre-filled pen
- 1 alcohol pad (not included in the carton)
- 1 cotton ball or gauze pad (not included in the carton)
- special disposal container (not included in the carton)

Wash and dry your hands.

STEP 3

Areas to inject

Areas to inject

Choose from these 3 areas to inject:
- front of left thigh
- front of right thigh
- your belly (abdomen) at least 5 cm from your belly button (navel)

Before the injection, wipe where you will inject in a circular motion with an alcohol pad.
- Do not touch or blow on the injection site after it is cleaned.
Allow the skin to dry before injecting
- Do not inject through clothes
- Do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks
- Do not inject into areas affected by psoriasis
STEP 4

Check liquid

Hold the pen with the dark grey cap pointing up, as shown.
- Pull the dark grey cap straight off
- Throw the dark grey cap away

Check the liquid through the inspection window.
- It is normal to see bubbles in the liquid
- The liquid should look clear to yellow and may contain tiny white or clear particles
- Do not use if the liquid is cloudy or contains flakes or large particles

STEP 5

Abdomen or Thigh

Hold the pen with your fingers on the grey hand grips.

Turn the pen so that the white needle sleeve points toward the injection site and you can see the green activator button.

Gently squeeze the skin at your injection site to make a raised area and hold it firmly.

Place the white needle sleeve straight (90º angle) against the raised injection site.
STEP 6

First “click” 15 seconds

Hold the pen so that you can see the green activator button and inspection window.

Push and keep pressing the pen down firmly against the raised injection site.
- The pen will activate only if the white needle sleeve is pressed down against the injection site before pressing the green activator button

Press the green activator button and hold the pen for 15 seconds.
- A loud “click” means the start of the injection

STEP 7

Second “click”

Yellow indicator

Keep pressing the pen down firmly against the injection site until the injection is complete.

This takes up to 15 seconds.

The injection is complete when:
- the pen has made a second “click” or
- the yellow indicator has filled the inspection window

STEP 8

When the injection is complete, slowly pull the pen out from the skin.

The white needle sleeve will cover the needle tip and make another “click.”

After completing the injection, place a cotton ball or gauze pad on the skin at the injection site.
- Do not rub the injection site
- Slight bleeding at the injection site is normal
STEP 9

Throw away the used pen in a special disposal container straight after use.
- Do not throw away the used pen in the household waste
- Your doctor, pharmacist or nurse will tell you how to return the full special disposal container

Skyrizi contains the active substance risankizumab.

Skyrizi is used to treat the following inflammatory diseases:

• Plaque psoriasis in adults
• Plaque psoriasis in children and adolescents from 6 to less than 18 years of age
• Psoriatic arthritis in adults

How Skyrizi works
This medicine works by stopping a protein in the body called ‘IL-23’, which causes inflammation.

Plaque psoriasis in adults
Skyrizi is used to treat adults with moderate to severe plaque psoriasis. Skyrizi reduces inflammation and can therefore help reduce symptoms of plaque psoriasis such as burning, itching, pain, redness, and scaling.

Plaque psoriasis in children and adolescents
Skyrizi is used to treat children and adolescents from 6 to less than 18 years of age with moderate to severe plaque psoriasis. Skyrizi reduces inflammation and can therefore help reduce symptoms of plaque psoriasis such as burning, itching, pain, redness, and scaling.

Psoriatic arthritis
Skyrizi is used to treat adults with psoriatic arthritis. Psoriatic arthritis is a disease that causes inflamed joints and psoriasis. If you have active psoriatic arthritis, you may first be given other medicines. If

these medicines do not work well enough, you will be given Skyrizi either alone or in combination with other medicines to treat your psoriatic arthritis.

Skyrizi reduces inflammation and can therefore help to reduce pain, stiffness, and swelling in and around your joints, pain and stiffness in your spine, psoriatic skin rash, psoriatic nail damage, and it may slow down damage to the bone and cartilage in your joints. These effects can ease your normal daily activities, reduce tiredness, and improve your quality of life.

Do not use Skyrizi
- if you are allergic to risankizumab or any of the other ingredients of this medicine (listed in section 6).
- if you have an infection, including active tuberculosis, which your doctor thinks is important.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before and during the use of Skyrizi:
- if you currently have an infection or if you have an infection that keeps coming back.
- if you have tuberculosis (TB).
- if you have recently received or plan to receive an immunisation (vaccine). You should not be given certain types of vaccines while using Skyrizi.

It is important to keep a record of the batch number of your Skyrizi.
Every time you get a new pack of Skyrizi, note down the date and the batch number (which is on the packaging after “Lot”) and keep this information in a safe place.

Serious allergic reactions
Skyrizi can cause serious side effects, including serious allergic reactions (‘anaphylaxis’).
Tell your doctor or seek medical help immediately if you notice any signs of an allergic reaction while you are taking Skyrizi such as:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- low blood pressure, which can cause dizziness or light-headedness
- severe itching of the skin, with a red rash or raised bumps

Children and adolescents
Skyrizi is not recommended for children under 6 years of age with plaque psoriasis.

Skyrizi is not recommended for children and adolescents under 18 years of age with psoriatic arthritis.
This is because Skyrizi has not been studied in this age group.

Other medicines and Skyrizi
Tell your doctor, pharmacist or nurse:
- if you are using, have recently used or might use any other medicines.
- if you have recently had or are going to have a vaccination. You should not be given certain types of vaccines while using Skyrizi.

If you are not sure, talk to your doctor, pharmacist or nurse before and during the use of Skyrizi.

Pregnancy, contraception and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. This is because it is not known how this medicine will affect the baby.

If you are a woman who can become pregnant, you should use contraception while using this medicine and for at least 21 weeks after your last dose of Skyrizi.

If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine.

Driving and using machines
Skyrizi is not likely to affect your driving and use of machines.

Skyrizi contains polysorbate and sodium
This medicine contains 0.2 mg of polysorbate 20 in each 150 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, that is to say essentially ‘sodium-free’.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

This medicine is given as an injection under your skin (called a ‘subcutaneous injection’).

How much Skyrizi to use

Plaque psoriasis in adults
Adults

How much and how often to take?
Each dose is 150 mg given as a single injection.

After the first dose, you will have the next dose
4 weeks later, and then every 12 weeks.

Plaque psoriasis in children and adolescents
Age and body weight
How much and how often to take?
Children and adolescents 6 to less than
18 years of age weighing at least 40 kg
Each dose is 150 mg given as a single injection.

After the first dose, you will have the next dose
4 weeks later, and then every 12 weeks.
Children and adolescents 6 to less than
18 years of age weighing less than 40 kg
Each dose is 55 mg given as a single injection.
A 55 mg pre-filled syringe is available.

After the first dose, you will have the next dose
4 weeks later, and then every 12 weeks.

Psoriatic arthritis in adults
Adults

How much and how often to take?
Each dose is 150 mg given as a single injection.

After the first dose, you will have the next dose
4 weeks later, and then every 12 weeks.

You and your doctor, pharmacist or nurse will decide if you should inject this medicine yourself. Do not inject yourself with this medicine unless you have been trained by your doctor, pharmacist or nurse. A caregiver may also give your injection after they have been trained.

Read section 7 ‘Instructions for use’ at the end of this leaflet before injecting Skyrizi yourself.

If you use more Skyrizi than you should
If you have used more Skyrizi than you should or the dose has been given sooner than prescribed, talk to your doctor.

If you forget to use Skyrizi
If you forget to use Skyrizi, inject a dose as soon as you remember. Talk to your doctor if you are not sure what to do.

If you stop using Skyrizi
Do not stop using Skyrizi without talking to your doctor first. If you stop treatment, your symptoms may come back.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Allergic reactions – these may need urgent treatment. Tell your doctor or get emergency medical help straight away if you notice any of the following signs:

Serious allergic reactions (‘anaphylaxis’) are rare in people taking Skyrizi (may affect up to 1 in a 1 000 people). Signs include:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- low blood pressure, which can cause dizziness or light-headedness

Talk to your doctor or get medical help immediately if you have the following symptoms.
Symptoms of a serious infection such as:
- fever, flu-like symptoms, night sweats
- feeling tired or short of breath, cough which will not go away
- warm, red and painful skin, or a painful skin rash with blisters

Your doctor will decide if you can keep using Skyrizi.

Other side effects
Tell your doctor, pharmacist or nurse if you get any of the following side effects

Very common: may affect more than 1 in 10 people
- upper respiratory infections with symptoms such as sore throat and stuffy nose

Common: may affect up to 1 in 10 people
- feeling tired
- fungal skin infection
- injection site reactions (such as redness or pain)
- itching
- headache
- rash
- eczema

Uncommon: may affect up to 1 in 100 people
- small raised red bumps on the skin
- hives (urticaria)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the syringe label and outer carton after ‘EXP’.

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

If needed, you may also store the pre-filled syringe out of the refrigerator (up to a maximum of 25°C) for up to 24 hours in the original carton to protect from light.

Do not use this medicine if the liquid is cloudy or contains flakes or large particles.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Skyrizi contains
- The active substance is risankizumab. Each pre-filled syringe contains 150 mg of risankizumab in 1 mL solution.
- The other ingredients are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20 and water for injections. See section 2, "Skyrizi contains polysorbate and sodium".

What Skyrizi looks like and contents of the pack
Skyrizi is a clear and colourless to yellow liquid in a pre-filled syringe with needle guard. The liquid may contain tiny white or clear particles.

Each pack contains 1 pre-filled syringe.

Marketing Authorisation Holder

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer

AbbVie S.r.l.
04011 Campoverde di Aprilia
(Latina)
Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811
Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел: +359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel: +36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. z o.o.
Tel: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o.
Tel: +385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: +357 22 34 74 40

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

Detailed information on this product is also available by scanning the QR code included below or on the outer carton with a smartphone. The same information is available at the following URL:
www.skyrizi.eu

QR code to be included

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.

7.
Instructions for use

Please read all of section 7 before using Skyrizi

Skyrizi pre-filled syringe

Plunger rod Finger grip Needle cover

Body of syringe

Important information to know before you inject Skyrizi
- You should receive training on how to inject Skyrizi before giving an injection. Talk to your doctor, pharmacist or nurse if you need help
- In children and adolescents 10 to less than 18 years of age, it is recommended that Skyrizi is given by or under supervision of an adult.
- In children 6 to less than 10 years of age, Skyrizi should be given by an adult.
- Mark the dates on your calendar so you know when to inject Skyrizi

• Keep Skyrizi in the original carton to protect the medicine from light until it is time to use it
• Do not inject if the liquid is cloudy or contains flakes or large particles. The liquid should look clear to yellow and may contain tiny white or clear particles
• Do not shake the syringe
• Wait to remove the needle cover until just before the injection

Return this medicine to the pharmacy
- if the expiry date (EXP) has passed
- if the liquid has ever been frozen (even if thawed)
- if the syringe has been dropped
- if the syringe has been damaged (for example, the needle is bent or the plunger rod is not connected to the body of the syringe)
- if the carton perforations are broken

For a more comfortable injection: Take the carton out of the refrigerator and leave it at room temperature, out of direct sunlight, for 15 to 30 minutes before injecting.
- Skyrizi should not be warmed in any other way (for example, in a microwave or in hot water)
- Keep the syringe in the carton until ready to inject

Follow the steps below each time you use Skyrizi

STEP 1

Remove the pre-filled syringe from the cardboard sleeve by holding the finger grip.
- Do not hold or pull plunger rod when removing the pre-filled syringe from the sleeve
- Do not remove the needle cover until you are ready to inject

Place the following items on a clean, flat surface:
- 1 pre-filled syringe
- 1 alcohol pad (not included in the carton)
- 1 cotton ball or gauze pad (not included in the carton)
- special disposal container (not included in the carton)

Wash and dry your hands.
STEP 2

Areas to inject
Choose from these 3 areas to inject:
- front of left thigh
- front of right thigh
- your belly (abdomen) at least 5 cm from your belly button (navel)

Before the injection, wipe where you will inject in a circular motion with an alcohol pad.
- Do not touch or blow on the injection site after it is cleaned.

Areas to inject

Allow the skin to dry before injecting
- Do not inject through clothes
- Do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks
- Do not inject into areas affected by psoriasis
STEP 3

Check liquid

Hold the syringe with the covered needle pointing down, as shown.

Check the liquid in the syringe.
- It is normal to see bubbles in the window, they do not need to be removed
- The liquid should look clear to yellow and may contain tiny white or clear particles
- Do not use if the liquid is cloudy or contains flakes or large particles

STEP 4

Removing the needle cover:
- Hold the syringe in one hand between the finger grip and needle cover
- With the other hand, gently pull the needle cover straight off
- Do not hold or pull the plunger rod when removing the needle cover
- You may see a drop of liquid at the end of the needle. This is normal
- Throw away the needle cover
- Do not touch the needle with your fingers or let the needle touch anything
- Do not use if the syringe has been dropped
- Do not use if the syringe has been damaged (for example, the needle is bent or the plunger rod is not connected to the body of the syringe) STEP 5

Hold the body of the syringe in one hand between the thumb and index finger, like you would a pencil.

Gently pinch the area of cleaned skin with your other hand and hold it firmly.

Insert the needle all the way into the skin at about a 45-degree angle using a quick, short movement. Keep the syringe steady at the same angle.

STEP 6

Needle guard

Slowly push the plunger rod all the way in until all of the liquid is injected.

Pull the needle out of the skin while keeping the syringe at the same angle.

Slowly take your thumb off the plunger rod.
The needle will then be covered by the needle guard.
- The needle guard will not activate unless all the liquid is injected
- Speak to your doctor, pharmacist or nurse if you think you have not given a full dose

Press a cotton ball or gauze pad where you have injected and hold for 10 seconds.

Do not rub the skin where you have injected.
You may have slight bleeding from where you injected. This is normal.

STEP 7

Throw away the used syringe in a special disposal container straight after use.
- Do not throw away the used syringe in the household waste
- Your doctor, pharmacist or nurse will tell you how to return the full special disposal container

Skyrizi contains the active substance risankizumab.

Skyrizi is used to treat the following inflammatory diseases:

• Plaque psoriasis in adults
• Plaque psoriasis in children and adolescents from 6 to less than 18 years of age
• Psoriatic arthritis in adults

How Skyrizi works
This medicine works by stopping a protein in the body called ‘IL-23’, which causes inflammation.

Plaque psoriasis in adults
Skyrizi is used to treat adults with moderate to severe plaque psoriasis. Skyrizi reduces inflammation and can therefore help reduce symptoms of plaque psoriasis such as burning, itching, pain, redness, and scaling.

Plaque psoriasis in children and adolescents
Skyrizi is used to treat children and adolescents from 6 to less than 18 years of age with moderate to severe plaque psoriasis. Skyrizi reduces inflammation and can therefore help reduce symptoms of plaque psoriasis such as burning, itching, pain, redness, and scaling.

Psoriatic arthritis
Skyrizi is used to treat adults with psoriatic arthritis. Psoriatic arthritis is a disease that causes inflamed joints and psoriasis. If you have active psoriatic arthritis, you may first be given other medicines. If

these medicines do not work well enough, you will be given Skyrizi either alone or in combination with other medicines to treat your psoriatic arthritis.

Skyrizi reduces inflammation and can therefore help to reduce pain, stiffness, and swelling in and around your joints, pain and stiffness in your spine, psoriatic skin rash, psoriatic nail damage, and it may slow down damage to the bone and cartilage in your joints. These effects can ease your normal daily activities, reduce tiredness, and improve your quality of life.

Do not use Skyrizi
- if you are allergic to risankizumab or any of the other ingredients of this medicine (listed in section 6).
- if you have an infection, including active tuberculosis, which your doctor thinks is important.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before and during the use of Skyrizi:
- if you currently have an infection or if you have an infection that keeps coming back.
- if you have tuberculosis (TB).
- if you have recently received or plan to receive an immunisation (vaccine). You should not be given certain types of vaccines while using Skyrizi.

It is important to keep a record of the batch number of your Skyrizi.
Every time you get a new pack of Skyrizi, note down the date and the batch number (which is on the packaging after “Lot”) and keep this information in a safe place.

Serious allergic reactions
Skyrizi can cause serious side effects, including serious allergic reactions (‘anaphylaxis’).
Tell your doctor or seek medical help immediately if you notice any signs of an allergic reaction while you are taking Skyrizi such as:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- low blood pressure, which can cause dizziness or light-headedness
- severe itching of the skin, with a red rash or raised bumps

Children and adolescents
Skyrizi is not recommended for children under 6 years of age with plaque psoriasis.

Skyrizi is not recommended for children and adolescents under 18 years of age with psoriatic arthritis.
This is because Skyrizi has not been studied in this age group.

Other medicines and Skyrizi
Tell your doctor, pharmacist or nurse:
if you are using, have recently used or might use any other medicines.
if you have recently had or are going to have a vaccination. You should not be given certain types of vaccines while using Skyrizi.

If you are not sure, talk to your doctor, pharmacist or nurse before and during the use of Skyrizi.

Pregnancy, contraception and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. This is because it is not known how this medicine will affect the baby.

If you are a woman who can become pregnant, you should use contraception while using this medicine and for at least 21 weeks after your last dose of Skyrizi.

If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine.

Driving and using machines
Skyrizi is not likely to affect your driving and use of machines.

Skyrizi contains polysorbate and sodium
This medicine contains 0.2 mg of polysorbate 20 in each 150 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

This medicine contains less than 1 mmol sodium (23 mg) per 150 mg dose, that is to say essentially ‘sodium-free’.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

This medicine is given as 2 injections under your skin (called ‘subcutaneous injections’).

How much Skyrizi to use

Plaque psoriasis in adults
Adults

How much and how often to take?
Each dose is 150 mg given as two 75 mg injections.

After the first dose, you will have the next dose
4 weeks later, and then every 12 weeks.

Plaque psoriasis in children and adolescents
Age and body weight
How much and how often to take?
Children and adolescents 6 to less than
18 years of age weighing at least 40 kg
Each dose is 150 mg given as two 75 mg injections.

After the first dose, you will have the next dose
4 weeks later, and then every 12 weeks.
Children and adolescents 6 to less than
18 years of age weighing less than 40 kg
Each dose is 55 mg given as a single injection.
A 55 mg pre-filled syringe is available.

After the first dose, you will have the next dose
4 weeks later, and then every 12 weeks.

Psoriatic arthritis in adults
Adults

How much and how often to take?
Each dose is 150 mg given as two 75 mg injections.

After the first dose, you will have the next dose
4 weeks later, and then every 12 weeks.

You and your doctor, pharmacist or nurse will decide if you should inject this medicine yourself. Do not inject yourself with this medicine unless you have been trained by your doctor, pharmacist or nurse. A caregiver may also give your injections after they have been trained.

Read section 7 ‘Instructions for use’ at the end of this leaflet before injecting Skyrizi yourself.

If you use more Skyrizi than you should
If you have used more Skyrizi than you should or the dose has been given sooner than prescribed, talk to your doctor.

If you forget to use Skyrizi
If you forget to use Skyrizi, inject a dose as soon as you remember. Talk to your doctor if you are not sure what to do.

If you stop using Skyrizi
Do not stop using Skyrizi without talking to your doctor first. If you stop treatment, your symptoms may come back.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Allergic reactions – these may need urgent treatment. Tell your doctor or get emergency medical help straight away if you notice any of the following signs:

Serious allergic reactions (‘anaphylaxis’) are rare in people taking Skyrizi (may affect up to 1 in a 1 000 people). Signs include:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- low blood pressure, which can cause dizziness or light-headedness

Talk to your doctor or get medical help immediately if you have the following symptoms.
Symptoms of a serious infection such as:
- fever, flu-like symptoms, night sweats
- feeling tired or short of breath, cough which will not go away
- warm, red and painful skin, or a painful skin rash with blisters

Your doctor will decide if you can keep using Skyrizi.

Other side effects
Tell your doctor, pharmacist or nurse if you get any of the following side effects

Very common: may affect more than 1 in 10 people
- upper respiratory infections with symptoms such as sore throat and stuffy nose

Common: may affect up to 1 in 10 people
- feeling tired
- fungal skin infection
- injection site reactions (such as redness or pain)
- itching
- headache
- rash
- eczema

Uncommon: may affect up to 1 in 100 people
- small raised red bumps on the skin
- hives (urticaria)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the syringe label and outer carton after ‘EXP’.

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled syringes in the outer carton in order to protect from light.

If needed, you may also store the pre-filled syringe out of the refrigerator (up to a maximum of 25°C) for up to 24 hours in the original carton to protect from the light.

Do not use this medicine if the liquid is cloudy or contains flakes or large particles.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Skyrizi contains
- The active substance is risankizumab. Each pre-filled syringe contains 75 mg of risankizumab in 0.5 mL solution.
- The other ingredients are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20 and water for injections. See section 2, "Skyrizi contains polysorbate and sodium".

What Skyrizi looks like and contents of the pack
Skyrizi is a clear and colourless to yellow liquid in a pre-filled syringe with needle guard. The liquid may contain tiny white or clear particles.

Each pack contains 2 pre-filled syringes.

Marketing Authorisation Holder

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer

AbbVie S.r.l.
04011 Campoverde di Aprilia
(Latina)

Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811
Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел:+359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel:+36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. Z o.o.
Tel: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o.
Tel: + 385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921
Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: +357 22 34 74 40

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

Detailed information on this product is also available by scanning the QR code included below or on the outer carton with a smartphone. The same information is available at the following URL:
www.skyrizi.eu

QR code to be included

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.

7.
Instructions for use

Please read all of section 7 before using Skyrizi

Plunger rod Finger grip Needle cover

Body of syringe

Important information to know before you inject Skyrizi
- You should receive training on how to inject Skyrizi before giving an injection. Talk to your doctor, pharmacist or nurse if you need help
- In children and adolescents 10 to less than 18 years of age, it is recommended that Skyrizi is given by or under supervision of an adult
- In children 6 to less than 10 years of age, Skyrizi should be given by an adult

• Mark the dates on your calendar so you know when to inject Skyrizi
• Keep Skyrizi in the original carton to protect the medicine from light until it is time to use it
• Do not inject if the liquid is cloudy or contains flakes or large particles. The liquid should look clear to yellow and may contain tiny white or clear particles
• Do not shake the syringe
• Wait to remove the needle cover until just before the injection

Return this medicine to the pharmacy
- if the expiry date (EXP) has passed
- if the liquid has ever been frozen (even if thawed)
- if the syringe has been dropped
- if the syringe has been damaged (for example, the needle is bent or the plunger rod is not connected to the body of the syringe)
- if the syringe paper tray cover is broken or missing

For a more comfortable injection: Take the carton out of the refrigerator and leave it at room temperature, out of direct sunlight, for 15 to 30 minutes before injecting.
- Skyrizi should not be warmed in any other way (for example, in a microwave or in hot water)
- Keep the syringes in the carton until ready to inject

Follow the steps below each time you use Skyrizi

STEP 1

Remove the pre-filled syringe from the cardboard sleeve by holding the finger grip.
- Do not hold or pull plunger rod when removing the prefilled syringe from the sleeve
- Do not remove the needle cover until you are ready to inject

Place the following items on a clean, flat surface:
- 2 pre-filled syringes
- 2 alcohol pads (not included in the carton)
- 2 cotton balls or gauze pads (not included in the carton)
- Special disposal container (not included in the carton)

Wash and dry your hands.

Start with one syringe for the first injection.

For a full dose, 2 injections are required, one after the other.
STEP 2

Areas to inject
Choose from these 3 areas to inject:
- front of left thigh
- front of right thigh
- your belly (abdomen) at least 5 cm from your belly button (navel)

Areas to inject
For the second syringe, inject at least 3 cm away from the first injection. Do not inject into the same place.

Before each injection, wipe where you will inject in a circular motion with an alcohol pad.
- Do not touch or blow on the injection site after it is cleaned.
Allow the skin to dry before injecting
- Do not inject through clothes
- Do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks
- Do not inject into areas affected by psoriasis
STEP 3

Check liquid
Hold the syringe with the covered needle pointing down, as shown.

Check the liquid in the syringe.

- It is normal to see bubbles in the window, they do not need to be removed
- The liquid should look clear to yellow and may contain tiny white or clear particles
- Do not use if the liquid is cloudy or contains flakes or large particles
STEP 4

Removing the needle cover:

• Hold the syringe in one hand between the finger grip and needle cover
• With the other hand, gently pull the needle cover straight off
• Do not hold or pull the plunger rod when removing the needle cover
• You may see a drop of liquid at the end of the needle. This is normal
• Throw away the needle cover
• Do not touch the needle with your fingers or let the needle touch anything
• Do not use if the syringe has been dropped
• Do not use if the syringe has been damaged (for example, the needle is bent or the plunger rod is not connected to the body of the syringe)

STEP 5

Hold the body of the syringe in one hand between the thumb and index finger, like you would a pencil.

Gently pinch the area of cleaned skin with your other hand and hold it firmly.

Insert the needle all the way into the skin at about a 45-degree angle using a quick, short movement. Keep the syringe steady at the same angle.
STEP 6

Needle guard
Slowly push the plunger rod all the way in until all of the liquid is injected.

Pull the needle out of the skin while keeping the syringe at the same angle.

Slowly take your thumb off the plunger rod.
The needle will then be covered by the needle guard.

• The needle guard will not activate unless all the liquid is injected
• Speak to your doctor, pharmacist or nurse if you think you have not given a full dose

Press a cotton ball or gauze pad where you have injected and hold for 10 seconds.

Do not rub the skin where you have injected.
You may have slight bleeding from where you injected. This is normal
STEP 7

2 Injections Required
For a full dose, two injections are needed, one after the other.

• Repeat Steps 2 through 6 with the second syringe
• Inject the second syringe straight after the first injection but at least 3 cm away from the first injection

STEP 8

Throw away used syringes in a special disposal container straight after use.

• Do not throw away used syringes in the household waste
• Your doctor, pharmacist or nurse will tell you how to return the full special disposal container

Skyrizi contains the active substance risankizumab.

Skyrizi is used to treat plaque psoriasis in children and adolescents from 6 to less than 18 years of age.

How Skyrizi works
This medicine works by stopping a protein in the body called ‘IL-23’, which causes inflammation.
Skyrizi reduces inflammation and can therefore help reduce symptoms of plaque psoriasis such as burning, itching, pain, redness, and scaling.

Do not use Skyrizi
- if you are allergic to risankizumab or any of the other ingredients of this medicine (listed in section 6).
- if you have an infection, including active tuberculosis, which your doctor thinks is important.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before and during the use of Skyrizi:
- if you currently have an infection or if you have an infection that keeps coming back.
- if you have tuberculosis (TB).
- if you have recently received or plan to receive an immunisation (vaccine). You should not be given certain types of vaccines while using Skyrizi.

It is important to keep a record of the batch number of your Skyrizi.
Every time you get a new pack of Skyrizi, note down the date and the batch number (which is on the packaging after “Lot”) and keep this information in a safe place.

Serious allergic reactions
Skyrizi can cause serious side effects, including serious allergic reactions (‘anaphylaxis’).
Tell your doctor or seek medical help immediately if you notice any signs of an allergic reaction while you are taking Skyrizi such as:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- low blood pressure, which can cause dizziness or light-headedness
- severe itching of the skin, with a red rash or raised bumps

Children and adolescents
Skyrizi is not recommended for children under 6 years of age.

Other medicines and Skyrizi
Tell your doctor, pharmacist or nurse:
- if you are using, have recently used or might use any other medicines.
- if you have recently had or are going to have a vaccination. You should not be given certain types of vaccines while using Skyrizi.

If you are not sure, talk to your doctor, pharmacist or nurse before and during the use of Skyrizi.

Pregnancy, contraception and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. This is because it is not known how this medicine will affect the baby.

If you can become pregnant, you should use contraception while using this medicine and for at least 21 weeks after your last dose of Skyrizi.

If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine.

Driving and using machines
Skyrizi is not likely to affect your driving and use of machines.

Skyrizi contains polysorbate and sodium
This medicine contains 0.07 mg of polysorbate 20 in each 55 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, that is to say essentially ‘sodium-free’.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

This medicine is given as an injection under your skin (called a ‘subcutaneous injection’).

How much Skyrizi to use

Age and body weight
How much and how often to take?
Children and adolescents 6 to less than
18 years of age weighing less than 40 kg
Each dose is 55 mg given as a single injection.

After the first dose, you will have the next dose
4 weeks later, and then every 12 weeks.
Children and adolescents 6 to less than
18 years of age weighing at least 40 kg
Each dose is 150 mg given as a single 150 mg injection or as two 75 mg injections.
A 150 mg pre-filled pen, 150 mg pre-filled syringe or a 75 mg pre-filled syringe is available.

After the first dose, you will have the next dose
4 weeks later, and then every 12 weeks.

You and your doctor, pharmacist or nurse will decide if you should inject this medicine yourself. Do not inject yourself with this medicine unless you have been trained by your doctor, pharmacist or nurse. A caregiver may also give your injection after they have been trained.

Read section 7 ‘Instructions for use’ at the end of this leaflet before injecting Skyrizi.

If you use more Skyrizi than you should
If you have used more Skyrizi than you should or the dose has been given sooner than prescribed, talk to your doctor.

If you forget to use Skyrizi
If you forget to use Skyrizi, inject a dose as soon as you remember. Talk to your doctor if you are not sure what to do.

If you stop using Skyrizi
Do not stop using Skyrizi without talking to your doctor first. If you stop treatment, your symptoms may come back.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Allergic reactions – these may need urgent treatment. Tell your doctor or get emergency medical help straight away if you notice any of the following signs:

Serious allergic reactions (‘anaphylaxis’) are rare in people taking Skyrizi (may affect up to 1 in a 1 000 people). Signs include:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- low blood pressure, which can cause dizziness or light-headedness

Talk to your doctor or get medical help immediately if you have the following symptoms.
Symptoms of a serious infection such as:
- fever, flu-like symptoms, night sweats
- feeling tired or short of breath, cough which will not go away
- warm, red and painful skin, or a painful skin rash with blisters

Your doctor will decide if you can keep using Skyrizi.

Other side effects
Tell your doctor, pharmacist or nurse if you get any of the following side effects.

Very common: may affect more than 1 in 10 people
- upper respiratory infections with symptoms such as sore throat and stuffy nose

Common: may affect up to 1 in 10 people
- feeling tired
- fungal skin infection
- injection site reactions (such as redness or pain)
- itching
- headache
- rash
- eczema

Uncommon: may affect up to 1 in 100 people
- small raised red bumps on the skin
- hives (urticaria)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the syringe label and outer carton after ‘EXP’.

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

If needed, you may also store the pre-filled syringe out of the refrigerator (up to a maximum of 25°C) for up to 24 hours in the original carton to protect from light.

Do not use this medicine if the liquid is cloudy or contains flakes or large particles.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Skyrizi contains
- The active substance is risankizumab. Each pre-filled syringe contains 55 mg of risankizumab in 0.37 mL solution.
- The other ingredients are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20 and water for injections.

What Skyrizi looks like and contents of the pack
Skyrizi is a clear and colourless to yellow liquid in a pre-filled syringe with needle guard. The liquid may contain tiny white or clear particles.

Each pack contains 1 pre-filled syringe.

Marketing Authorisation Holder

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer

AbbVie S.r.l.
S.R. 148 Pontina, Km 52 SNC
04011 Campoverde di Aprilia (LT)
Italy

or

AbbVie Biotechnology GmbH
Knollstrasse
67061 Ludwigshafen
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811
Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел: +359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel: +36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. z o.o.
Tel: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o.
Tel: +385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: +357 22 34 74 40

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

Detailed information on this product is also available by scanning the QR code included below or on the outer carton with a smartphone. The same information is available at the following URL:
www.skyrizi.eu

QR code to be included

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.

7.
Instructions for use

Please read all of section 7 before using Skyrizi

Skyrizi pre-filled syringe

Plunger rod Finger grip Needle cover

Body of syringe

Important information to know before you inject Skyrizi
- You should receive training on how to inject Skyrizi before giving an injection. Talk to your doctor, pharmacist or nurse if you need help
- In children and adolescents 10 to less than 18 years of age, it is recommended that Skyrizi is given by or under supervision of an adult.
- In children 6 to less than 10 years of age, Skyrizi should be given by an adult.
- Mark the dates on your calendar so you know when to inject Skyrizi
- Keep Skyrizi in the original carton to protect the medicine from light until it is time to use it
- Do not inject if the liquid is cloudy or contains flakes or large particles. The liquid should look clear to yellow and may contain tiny white or clear particles
- Do not shake the syringe
- Wait to remove the needle cover until just before the injection

Return this medicine to the pharmacy
- if the expiry date (EXP) has passed
- if the liquid has ever been frozen (even if thawed)
- if the syringe has been dropped
- if the syringe has been damaged (for example, the needle is bent or the plunger rod is not connected to the body of the syringe)
- if the carton perforations are broken

For a more comfortable injection: Take the carton out of the refrigerator and leave it at room temperature, out of direct sunlight, for 15 to 30 minutes before injecting.
- Skyrizi should not be warmed in any other way (for example, in a microwave or in hot water)
- Keep the syringe in the carton until ready to inject

Follow the steps below each time you use Skyrizi

STEP 1

Remove the pre-filled syringe from the cardboard sleeve by holding the finger grip.
- Do not hold or pull plunger rod when removing the pre-filled syringe from the sleeve
- Do not remove the needle cover until you are ready to inject

Place the following items on a clean, flat surface:
- 1 pre-filled syringe
- 1 alcohol pad (not included in the carton)
- 1 cotton ball or gauze pad (not included in the carton)
- special disposal container (not included in the carton)

Wash and dry your hands.
STEP 2

Areas to inject

Areas to inject

Choose from these 3 areas to inject:
- front of left thigh
- front of right thigh
- your belly (abdomen) at least 5 cm from your belly button (navel)

Before the injection, wipe where you will inject in a circular motion with an alcohol pad.
- Do not touch or blow on the injection site after it is cleaned.
Allow the skin to dry before injecting
- Do not inject through clothes
- Do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks
- Do not inject into areas affected by psoriasis

STEP 3

Check liquid

Hold the syringe with the covered needle pointing down, as shown.

Check the liquid in the syringe.
- It is normal to see bubbles in the window, they do not need to be removed
- The liquid should look clear to yellow and may contain tiny white or clear particles
- Do not use if the liquid is cloudy or contains flakes or large particles
STEP 4

Removing the needle cover:
- Hold the syringe in one hand between the finger grip and needle cover
- With the other hand, gently pull the needle cover straight off
- Do not hold or pull the plunger rod when removing the needle cover
- You may see a drop of liquid at the end of the needle. This is normal
- Throw away the needle cover
- Do not touch the needle with your fingers or let the needle touch anything
- Do not use if the syringe has been dropped
- Do not use if the syringe has been damaged (for example, the needle is bent or the plunger rod is not connected to the body of the syringe) STEP 5

Hold the body of the syringe in one hand between the thumb and index finger, like you would a pencil.

Gently pinch the area of cleaned skin with your other hand and hold it firmly.

Insert the needle all the way into the skin at about a 45-degree angle using a quick, short movement. Keep the syringe steady at the same angle.

STEP 6

Needle guard

Slowly push the plunger rod all the way in until all of the liquid is injected.

Pull the needle out of the skin while keeping the syringe at the same angle.

Slowly take your thumb off the plunger rod.
The needle will then be covered by the needle guard.
- The needle guard will not activate unless all the liquid is injected
- Speak to your doctor, pharmacist or nurse if you think you have not given a full dose

Press a cotton ball or gauze pad where you have injected and hold for 10 seconds.

Do not rub the skin where you have injected.
You may have slight bleeding from where you injected. This is normal.

STEP 7

Throw away the used syringe in a special disposal container straight after use.
- Do not throw away the used syringe in the household waste
- Your doctor, pharmacist or nurse will tell you how to return the full special disposal container

Skyrizi contains the active substance risankizumab.

Skyrizi is used to treat adult patients with:
- moderate to severe Crohn’s disease
- moderate to severe ulcerative colitis

How Skyrizi works

This medicine works by stopping a protein in the body called ‘IL-23’, which causes inflammation.

Crohn’s disease
Crohn’s disease is an inflammatory disease of the digestive tract. If you have active Crohn’s disease you will first be given other medicines. If these medicines do not work well enough, you will be given Skyrizi to treat your Crohn’s disease.

Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the large bowel. If you have active ulcerative colitis you will first be given other medicines. If these medicines do not work well enough or if you cannot take these medicines, you will be given Skyrizi to treat your ulcerative colitis.

Skyrizi reduces the inflammation and can therefore help to reduce the signs and symptoms of your disease.

You should not be given Skyrizi
- if you are allergic to risankizumab or any of the other ingredients of this medicine (listed in section 6).
- if you have an infection, including active tuberculosis, which your doctor thinks is important.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before and during the use of Skyrizi:
- if you currently have an infection or if you have an infection that keeps coming back.
- if you have tuberculosis (TB).
- if you have recently received or plan to receive an immunisation (vaccine). You should not be given certain types of vaccines while using Skyrizi.

It is important that your doctor or nurse keep a record of the batch number of your Skyrizi.
Every time you get a new pack of Skyrizi, your doctor or nurse must note down the date and the batch number (which is on the packaging after “Lot”).

Serious allergic reactions
Skyrizi can cause serious side effects, including serious allergic reactions (‘anaphylaxis’).
Tell your doctor or seek medical help immediately if you notice any signs of an allergic reaction while you are taking Skyrizi such as:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- low blood pressure, which can cause dizziness or light-headedness
- severe itching of the skin, with a red rash or raised bumps

Children and adolescents
Skyrizi is not recommended for children and adolescents under 18 years of age. This is because the use of Skyrizi has not been confirmed in this age group.

Other medicines and Skyrizi
Tell your doctor, pharmacist or nurse:
- if you are using, have recently used or might use any other medicines.
- if you have recently had or are going to have a vaccination. You should not be given certain types of vaccines while using Skyrizi.

If you are not sure, talk to your doctor, pharmacist or nurse before and during the use of Skyrizi.

Pregnancy, contraception and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. This is because it is not known how this medicine will affect the baby.

If you are a woman who can become pregnant, you should use contraception while using this medicine and for at least 21 weeks after your last dose of Skyrizi.

If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine.

Driving and using machines
Skyrizi is not likely to affect your driving and use of machines.

Skyrizi contains polysorbate and sodium
This medicine contains 2 mg of polysorbate 20 in each 600 mg dose and 4 mg of polysorbate 20 in each 1 200 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

This medicine contains less than 1 mmol sodium (23 mg) per 600 mg dose and 1 200 mg dose, that is to say essentially ‘sodium-free’.

You will begin treatment with Skyrizi with a starting dose which will be given by your doctor or nurse through a drip in your arm (intravenous infusion).

Starting doses
Crohn’s disease
How much?
When?
600 mg
When your doctor tells you
600 mg
4 weeks after 1st dose
600 mg
4 weeks after 2nd dose

Ulcerative colitis
How much?
When?
1 200 mg
When your doctor tells you
1 200 mg
4 weeks after 1st dose
1 200 mg
4 weeks after 2nd dose

Afterwards, you will receive Skyrizi as an injection under your skin. See package leaflet for Skyrizi 90 mg pre-filled syringe, 180 mg and 360 mg solution for injection in cartridge, and 180 mg pre-filled syringe.

Maintenance doses
Crohn’s disease
How much?
When?
1st maintenance dose
360 mg
4 weeks after the last starting dose (at week 12)
Further doses
360 mg
Every 8 weeks, starting after the 1st maintenance dose

Ulcerative colitis
How much?
When?
1st maintenance dose
180 mg or 360 mg
4 weeks after the last starting dose (at week 12)
Further doses
180 mg or 360 mg
Every 8 weeks, starting after the 1st maintenance dose

If you forget to use Skyrizi
If you forget or miss the appointment for any of your doses, contact your doctor to reschedule your appointment as soon as you remember.

If you stop using Skyrizi
Do not stop using Skyrizi without talking to your doctor first. If you stop treatment, your symptoms may come back.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Allergic reactions – these may need urgent treatment. Tell your doctor or get emergency medical help straight away if you notice any of the following signs:

Serious allergic reactions (‘anaphylaxis’) are rare in people taking Skyrizi (may affect up to 1 in a 1 000 people). Signs include:
- difficulty breathing or swallowing

• swelling of the face, lips, tongue or throat
• low blood pressure, which can cause dizziness or light-headedness

Talk to your doctor or get medical help immediately if you have the following symptoms.
Symptoms of a serious infection such as:
- fever, flu-like symptoms, night sweats
- feeling tired or short of breath, cough which will not go away
- warm, red and painful skin, or a painful skin rash with blisters

Your doctor will decide if you can keep using Skyrizi.

Other side effects
Tell your doctor, pharmacist or nurse if you get any of the following side effects

Very common: may affect more than 1 in 10 people
- upper respiratory infections with symptoms such as sore throat and stuffy nose

Common: may affect up to 1 in 10 people
- feeling tired
- fungal skin infection
- injection site reactions (such as redness or pain)
- itching
- headache
- rash
- eczema

Uncommon: may affect up to 1 in 100 people
- small raised red bumps on the skin
- hives (urticaria)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

Skyrizi 600 mg concentrate for solution for infusion is given in a hospital or clinic and patients should not need to store or handle it.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the vial label and outer carton after ‘EXP’.

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the vial in the original carton in order to protect from light.

Do not shake the Skyrizi vial. Prolonged vigorous shaking can damage the medicine.

Do not use this medicine if the liquid is cloudy or contains flakes or large particles.

Each vial is for single use only.

Do not throw away any medicines via wastewater or household waste. These measures will help protect the environment.

What Skyrizi contains

• The active substance is risankizumab. Each vial contains 600 mg of risankizumab in 10 mL solution.
• The other ingredients are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20 and water for injections. See section 2, "Skyrizi contains polysorbate and sodium".

What Skyrizi looks like and contents of the pack

Skyrizi is a clear and colourless to slightly yellow liquid in a vial. The liquid may contain tiny white or clear particles.

Each pack contains 1 vial.

Marketing Authorisation Holder

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer

AbbVie S.r.l.
04011 Campoverde di Aprilia
(Latina)
Italy

or

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811
Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел: +359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111
Magyarország
AbbVie Kft.
Tel: +36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. z o.o.
Tel: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o.
Tel: +385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: +357 22 34 74 40

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

Detailed and updated information on this product is available by scanning the QR code included below or on the outer carton with a smartphone. The same information is also available at the following URL: www.skyrizi.eu

QR code to be included

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.

---------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only

Traceability

In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.

Instructions for use

1.
This medicinal product should be prepared by a healthcare professional using aseptic technique.

2.
It must be diluted before administration.

3.
The solution for infusion is prepared by dilution of the concentrate into an infusion bag or glass bottle containing 5% dextrose in water (D5W) or sodium chloride 9 mg/mL (0.9%) solution for infusion to a final concentration of approximately 1.2 mg/mL to 6 mg/mL. Refer to table below for dilution instructions based on patient’s indication.

Indication
Intravenous induction dose
Number of
600 mg/ 10 mL vials
Total volume of 5% dextrose or sodium chloride 9 mg/mL
(0.9%) solution for infusion
Crohn’s disease
600 mg
100 mL, or 250 mL, or 500 mL
Ulcerative colitis
1 200 mg
250 mL, or 500 mL

4.
The solution in the vial and dilutions should not be shaken.

5.
Prior to the start of the intravenous infusion, the content of the infusion bag or glass bottle should be at room temperature.
6.
Infuse the diluted solution over a period of at least one hour for the 600 mg dose; at least two hours for the 1 200 mg dose.
7.
The vial solution should not be administered concomitantly in the same intravenous line with other medicinal products.
Each vial is for single use only and any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Storage of diluted solution

Chemical and physical in-use stability has been demonstrated for 20 hours at 2°C to 8°C (protected from light) or up to 8 hours at room temperature (protected from sunlight). Storage time at room temperature begins once the diluted solution has been prepared. The infusion should be completed within 8 hours after dilution in the infusion bag. Exposure to indoor light is acceptable during room temperature storage and administration.
From a microbiological point of view, the prepared infusion should be used immediately. If not used immediately, in-use storage time and conditions prior to use are the responsibility of the user and should not be longer than 20 hours at 2°C to 8°C. Do not freeze.

Skyrizi contains the active substance risankizumab.

Skyrizi is used to treat adult patients with:
- moderate to severe Crohn’s disease
- moderate to severe ulcerative colitis

How Skyrizi works

This medicine works by stopping a protein in the body called ‘IL-23’, which causes inflammation.

Crohn’s disease
Crohn’s disease is an inflammatory disease of the digestive tract. If you have active Crohn’s disease you will first be given other medicines. If these medicines do not work well enough, you will be given Skyrizi to treat your Crohn’s disease.

Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the large bowel. If you have active ulcerative colitis you will first be given other medicines. If these medicines do not work well enough or if you cannot take these medicines, you will be given Skyrizi to treat your ulcerative colitis.

Skyrizi reduces the inflammation and can therefore help to reduce the signs and symptoms of your disease.

Do not use Skyrizi
- if you are allergic to risankizumab or any of the other ingredients of this medicine (listed in section 6).
- if you have an infection, including active tuberculosis, which your doctor thinks is important.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before and during the use of Skyrizi:
- if you currently have an infection or if you have an infection that keeps coming back.
- if you have tuberculosis (TB).
- if you have recently received or plan to receive an immunisation (vaccine). You should not be given certain types of vaccines while using Skyrizi.

It is important to keep a record of the batch number of your Skyrizi.
Every time you get a new pack of Skyrizi, note down the date and the batch number (which is on the packaging after “Lot”) and keep this information in a safe place.

Serious allergic reactions
Skyrizi can cause serious side effects, including serious allergic reactions (‘anaphylaxis’).
Tell your doctor or seek medical help immediately if you notice any signs of an allergic reaction while you are taking Skyrizi such as:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- low blood pressure, which can cause dizziness or light-headedness
- severe itching of the skin, with a red rash or raised bumps

Children and adolescents
Skyrizi is not recommended for children and adolescents under 18 years of age. This is because the use of Skyrizi has not been confirmed in this age group.

Other medicines and Skyrizi
Tell your doctor, pharmacist or nurse:
- if you are using, have recently used or might use any other medicines.
- if you have recently had or are going to have a vaccination. You should not be given certain types of vaccines while using Skyrizi.

If you are not sure, talk to your doctor, pharmacist or nurse before and during the use of Skyrizi.

Pregnancy, contraception and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. This is because it is not known how this medicine will affect the baby.

If you are a woman who can become pregnant, you should use contraception while using this medicine and for at least 21 weeks after your last dose of Skyrizi.

If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine.

Driving and using machines
Skyrizi is not likely to affect your driving and use of machines.

Skyrizi contains polysorbate and sodium
This medicine contains 0.24 mg of polysorbate 20 in each 180 mg dose and 0.48 mg of polysorbate 20 in each 360 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

This medicine contains less than 1 mmol sodium (23 mg) per cartridge, that is to say essentially ‘sodium-free’.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

This medicine is given as an injection under your skin (called a ‘subcutaneous injection’).

How much Skyrizi to use

You will begin treatment with Skyrizi with a starting dose which will be given by your doctor or nurse through a drip in your arm (intravenous infusion).

Starting doses
Crohn’s disease
How much?
When?
600 mg
When your doctor tells you
600 mg
4 weeks after 1st dose
600 mg
4 weeks after 2nd dose

Ulcerative colitis
How much?
When?
1 200 mg
When your doctor tells you
1 200 mg
4 weeks after 1st dose
1 200 mg
4 weeks after 2nd dose

Afterwards, you will receive Skyrizi as an injection under your skin.

Maintenance doses
Crohn’s disease
How much?
When?
1st maintenance dose 360 mg
4 weeks after the last starting dose (at week 12)
Further doses
360 mg
Every 8 weeks, starting after the
1st maintenance dose

Ulcerative colitis
How much?
When?
1st maintenance dose 180 mg or 360 mg
4 weeks after the last starting dose (at week 12)
Further doses
180 mg or 360 mg
Every 8 weeks, starting after the 1st maintenance dose

You and your doctor, pharmacist or nurse will decide if you should inject this medicine yourself. Do not inject yourself with this medicine unless you have been trained by your doctor, pharmacist or nurse. A caregiver may also give your injection after they have been trained.

Read section 7 ‘Instructions for use’ at the end of this leaflet before injecting Skyrizi yourself.

If you use more Skyrizi than you should
If you have used more Skyrizi than you should or the dose has been given sooner than prescribed, talk to your doctor.

If you forget to use Skyrizi
If you forget to use Skyrizi, inject a dose as soon as you remember. Talk to your doctor if you are not sure what to do.

If you stop using Skyrizi
Do not stop using Skyrizi without talking to your doctor first. If you stop treatment, your symptoms may come back.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Allergic reactions – these may need urgent treatment. Tell your doctor or get emergency medical help straight away if you notice any of the following signs:

Serious allergic reactions (‘anaphylaxis’) are rare in people taking Skyrizi (may affect up to 1 in a 1 000 people). Signs include:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- low blood pressure, which can cause dizziness or light-headedness

Talk to your doctor or get medical help immediately if you have the following symptoms.
Symptoms of a serious infection such as:
- fever, flu-like symptoms, night sweats
- feeling tired or short of breath, cough which will not go away
- warm, red and painful skin, or a painful skin rash with blisters

Your doctor will decide if you can keep using Skyrizi.

Other side effects
Tell your doctor, pharmacist or nurse if you get any of the following side effects

Very common: may affect more than 1 in 10 people
- upper respiratory infections with symptoms such as sore throat and stuffy nose

Common: may affect up to 1 in 10 people
- feeling tired
- fungal skin infection
- injection site reactions (such as redness or pain)
- itching
- headache
- rash
- eczema

Uncommon: may affect up to 1 in 100 people
- small raised red bumps on the skin
- hives (urticaria)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the cartridge label and outer carton after ‘EXP’.

Store in a refrigerator (2°C - 8°C). Do not freeze.

If needed, you may also store the cartridge out of the refrigerator (up to a maximum of 25°C) for up to 24 hours.

Keep the cartridge in the original carton in order to protect from light.

Do not use this medicine if the liquid is cloudy or contains flakes or large particles.

Each on-body injector with cartridge is for single use only.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Skyrizi contains
The active substance is risankizumab.

Skyrizi 180 mg solution for injection in cartridge
- Each cartridge contains 180 mg of risankizumab in 1.2 mL solution.
- The other ingredients are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20 and water for injections. See section 2, "Skyrizi contains polysorbate and sodium".

Skyrizi 360 mg solution for injection in cartridge
- Each cartridge contains 360 mg of risankizumab in 2.4 mL solution.
- The other ingredients are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20 and water for injections. See section 2, "Skyrizi contains polysorbate and sodium".

What Skyrizi looks like and contents of the pack
Skyrizi is a clear and colourless to yellow liquid in a cartridge. The liquid may contain tiny white or clear particles.

Each pack contains 1 cartridge and 1 on-body injector.

Marketing Authorisation Holder and Manufacturer

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
AbbVie SA
Lietuva
AbbVie UAB

Tél/Tel: +32 10 477811
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел: +359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel: +36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
Abbvie Sp. z o.o.
Tel: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o.
Tel: +385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: +357 22 34 74 40

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

Detailed and updated information on this product is available by scanning the QR code included below or on the outer carton with a smartphone. The same information is also available at the following URL: www.skyrizi.eu

QR code to be included

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.

7.
Instructions for use

Please read all of section 7 before using Skyrizi

Skyrizi on-body injector

Front view

Adhesive material

Status light

Start button
Do not touch until ready to inject

Grey door
Do not close grey door without cartridge inside
Medicine window
Pull tabs

Back view
Clear plastic strip

Needle cover

Adhesive backing

Take care. Needle inside
(under needle cover)
Do not touch the needle cover area or needle
Small section green pull tab
Large section green pull tab

Side view

Door latch
Opening side has ridges
Grey door should be slightly open
Do not close grey door without cartridge inside

Needle cover

Needle inside (under needle cover)
Do not touch the needle cover area or needle

Cartridge

White plunger expands through chamber towards cartridge bottom as the medicine is injected.

Medicine

Smaller bottom tip

Larger cartridge top
Do not twist or remove

Expiry date (EXP)
Located on cartridge label

Important information to know before you inject Skyrizi
- You should receive training on how to inject Skyrizi before giving an injection. Talk to your doctor, pharmacist or nurse if you need help
- Mark the dates on your calendar so you know when to inject Skyrizi
- The single use on-body injector is designed for use with Skyrizi cartridge only
- Keep Skyrizi in the original carton to protect the medicine from light until it is time to use it
- Take the carton out of the refrigerator and leave it at room temperature, out of direct sunlight, for at least 45 up to 90 minutes before injecting o The on-body injector will not work if Skyrizi is not left at room temperature to warm for at least 45 minutes
- Do not let the on-body injector get wet with water or any other liquids
- Do not touch the start button until you place the on-body injector loaded with the cartridge onto your skin and are ready to inject o You can only press the start button one time
- Physical activity should be limited during the injection process. Moderate physical activities can be done, such as walking, reaching and bending
- Do not delay in injecting the medicine after loading the cleaned cartridge into the on-body injector. Waiting will dry out the medicine and the on-body injector will not work afterwards
- Do not inject if the liquid in the inspection window is cloudy or contains flakes or large particles. The liquid should look clear to yellow and may contain tiny white or clear particles
- Do not shake the carton, cartridge or on-body injector
- Do not re-use the cartridge or the on-body injector

Return this medicine to the pharmacy
- if the expiry date (EXP) has passed
- if the liquid has ever been frozen (even if thawed)
- if the cartridge or on-body injector has been dropped or damaged
- if the carton perforations are broken
- if the white paper tray cover is broken or missing

Follow the steps below each time you use Skyrizi

STEP 1 - Get ready

Take the carton out of the refrigerator and leave it at room temperature, out of direct sunlight, for at least 45 up to 90 minutes before injecting.
• The on-body injector will not work if Skyrizi is not left at room temperature to warm for at least 45 minutes • Check expiry date (EXP) on the carton. Do not use Skyrizi if the expiry date (EXP) has passed • Do not remove the cartridge or on-body injector from the carton while allowing Skyrizi to reach room temperature • Do not warm Skyrizi in any other way. For example, do not warm it in a microwave or in hot water

Special disposal container

Gather all supplies and wash your hands
Place the following items on a clean, flat surface
• plastic tray containing 1 on-body injector and 1 cartridge
• 2 alcohol pads (not included in the carton)
• 1 cotton ball or gauze pad (not included in the carton)
• special disposal container (not included in the carton)

Wash and dry your hands.

Remove the white paper tray seal
• Locate the black arrow
• Peel away the white paper tray seal from the plastic tray

Lift the plastic cover
• Locate the rounded opening on the top cover
• Insert your index finger in the opening and place your thumb on the opposite side • Lift the cover to remove and set it aside • Do not touch the grey start button until it is time to inject. It can only be pressed one time

Grey door

Start button

Needle inside
(under needle cover)
Inspect the on-body injector
• Check that the on-body injector is intact and not damaged
• The grey door should be slightly open
• If the grey door does not open, press in firmly on the grey door ridges (left side of door) and swing open the door • Do not close the grey door before the cartridge is loaded • Do not use on-body injector if you drop it, discover missing pieces, or if it’s damaged • Do not touch the grey start button until it is time to inject. It can be pressed one time only • Do not touch the needle cover area or needle

If the grey start button is pressed before placing it on your body, the on-body injector can no longer be used. If this happens, speak to your doctor, pharmacist or nurse.

Proceed to the next step.

STEP 2 - Set up on-body injector
Grey door

Back view

Needle inside
(under needle cover)

Needle cover
Fully open the grey door
• Avoid touching the needle cover area on the back of the on-body injector. The needle is behind the needle cover • Swing the grey door all the way to the right to open it • If the grey door does not open, press in firmly on the grey door ridges (left side of door) and swing open the door • Do not close the grey door before the cartridge is loaded • Do not touch the grey start button until it is time to inject. It can only be pressed one time

Put the on-body injector aside.

Larger cartridge top

Smaller bottom tip

Inspect the cartridge
• Do not twist or remove cartridge top

Carefully remove the cartridge from the plastic tray.

Check the cartridge
• The liquid should look clear to yellow and may contain tiny white or clear particles. It is normal to see one or more bubbles • Do not use if the liquid is cloudy, discoloured, or contains flakes or large particles • The cartridge parts and the clear plastic are not cracked or broken • Do not use if the liquid has been frozen (even if thawed).
• Do not use the cartridge if you drop it, discover missing pieces, or it is damaged.

Smaller bottom tip
Clean centre of smaller bottom tip
Clean the smaller bottom tip of the cartridge
Locate the smaller bottom tip of the cartridge.
- Clean smaller bottom tip of the cartridge with an alcohol pad. Make sure to use the alcohol pad to clean the centre of the smaller bottom tip of the cartridge
- Do not touch the smaller bottom tip of the cartridge after cleaning

Insert straight
‘click’

Load the cleaned cartridge into the on-body injector
- Do not twist or remove the cartridge top
- Do not touch the grey start button until it is time to inject. It can only be pressed one time
- Insert the smaller bottom tip of the cartridge into the on-body injector first
- Firmly push down on the cartridge top until you hear a ‘click’ and it is fully inserted
- After loading the cartridge, you may see a few drops of medicine on the back of the on-body injector. This is normal

Make sure to proceed to the next step without delay after inserting the cartridge. Waiting will dry out the medicine and the on-body injector will not work afterwards.

‘snap’
No Gaps
Confirm cartridge is inserted and close the grey door
- Confirm the cartridge is fully inserted
- Do not close the grey door if the cartridge is not fully inserted or is missing
- Swing the grey door to the left, then squeeze firmly and listen for the grey door to ‘snap’ shut.

No gaps should exist between the grey door and the on-body injector
- The grey door should stay locked after loading the cartridge

Do not touch the grey start button until it is time to inject. It can only be pressed one time.

Proceed without delay to the next step.

STEP 3 - Prepare to inject

Areas to inject

Areas to inject

Choose and clean your injection site
Choose from these 3 areas to inject:
- front of left thigh
- front of right thigh
- your belly (abdomen) at least 5 cm from your belly button (navel)

Do not inject into areas of the skin that naturally fold or bulge because the on-body injector could fall off during wear.

Before the injection, wipe where you will inject in a circular motion with an alcohol pad.
- Do not touch or blow on the injection site after it is cleaned. Allow the skin to dry before placing the on-body injector on the skin
- Do not inject through clothes
- Do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks, moles or excessive hair. You can trim the excessive hair from the injection site

Small section Large section

Needle inside
(under needle cover)

Activated injector
Status light flashing blue

‘beep-beep-beep’

Peel both tabs to expose skin adhesive
Turn the on-body injector over to find both green pull tabs
- Avoid touching the needle cover (needle inside)

Peel away the large section using the green pull tab to expose the skin adhesive.

Peel away the small section using the green pull tab to expose the skin adhesive. This will remove the clear plastic strip, activating the on-body injector.
- Check the status light when the on-body injector beeps
- The status light will flash blue when the on-body injector is activated
- If the status light does not flash blue, speak to your doctor, pharmacist or nurse
- Do not press the grey start button yet
- Do not touch the needle cover or the needle
- Do not pull the adhesive material off on-body injector or allow the sticky side to fold and stick to itself

The Skyrizi on-body injector must be placed on the skin and injection must be started within 30 minutes after removing the green pull tabs or it will not work.
Make sure to proceed to next step without delay.

‘beep-beep-beep-beep-beep’

If the status light flashes red and beeps, the on- body injector is not working properly. Do not continue to use it.
Speak to your doctor, pharmacist or nurse for assistance.
If the on-body injector is attached to your body, carefully remove it from your skin.
Prepare the on-body injector for placement
- For the belly (abdomen), move and hold the skin to create a firm, flat surface for injection at least 5 cm from your belly button (navel). Make sure to sit up straight to avoid skin folds and bulges
- You do not need to pull the skin flat for the front of left thigh or right thigh

Make sure to place the on-body injector so that you can see the blue status light.

Place the on-body injector on your skin
- When the blue light flashes, the on-body injector is ready. Place the on-body injector onto the cleaned skin with the status light visible
- Do not place the on-body injector on clothes.
Only place on bare skin
- Run your finger around the adhesive material to secure it
- Do not move or adjust the on-body injector after it has been placed on your skin

Proceed without delay to the next step.

STEP 4 - Inject Skyrizi

‘click’
‘beep-beep-beep’

Start injection
- Do not touch the grey start button until you place the on-body injector loaded with the cartridge onto your skin and are ready to inject. You can only press the start button one time
- Firmly press the grey start button until you hear a
‘click’. Then release the grey start button
- You may feel a needle pinch
- Check the status light when the on-body injector beeps
- After starting the injection, the status light will continuously flash green
- After starting the injection, you will hear pumping sounds as the on-body injector delivers the medicine

Do not continue to use the on-body injector if status light flashes red and beeps. Carefully remove from skin if the status light flashes red. If this happens, speak to your doctor, pharmacist or nurse Wait for the injection to finish
- It may take up to 5 minutes to complete the full dose of medicine. The on-body injector will automatically stop when the injection is finished
- During the injection, the status light will continue to flash green
- During the injection, you will hear pumping sounds as the on-body injector continues delivering the medicine
- During the injection, moderate physical activities can be done, such as walking, reaching and bending.

Do not continue to use the on-body injector if the status light flashes red and beeps. Carefully remove it from the skin if the status light flashes red. If this happens, speak to your doctor, pharmacist or nurse.

‘beep-beep-beep’

Injection is complete when
- The on-body injector stops on its own
- You hear a beep and the status light changes to solid green. If the status light has changed to solid green, this means that the injection is complete

‘beep-beep-beep’

Remove the on-body injector
- Do not remove the on-body injector if the status light is still flashing green and the injection is not finished
- Do not put your fingers on the back side of the on-body injector when removing it from your skin
- When the injection is done, grab the corner of the adhesive to carefully peel the on-body injector from the skin
- Avoid touching the needle cover or needle on the back of the on-body injector
- After removing the on-body injector, you will hear several beeps and the status light will turn off
- The needle cover will cover the needle when the on-body injector is removed from the skin
- It is normal to see a few small drops of liquid on your skin after removing the on-body injector
- Press a cotton ball or gauze pad over the injection site on your skin and hold for 10 seconds
- Do not rub the injection site
- Slight bleeding at the injection site is normal

Proceed to the next step.

STEP 5 - Finish

Check the on-body injector
Inspect the medicine window and status light.

Check to see that the white plunger fills the entire medicine window and the solid green light turns off, letting you know that all the medicine has been injected.
- If the white plunger does not fill the window, speak to your doctor, pharmacist or nurse

Special disposal container
Disposal
Throw away the used on-body injector in a special disposal container straight after use.
- The on-body injector contains batteries, electronics, and a needle
- Leave the cartridge in the on-body injector
- Do not throw away the used on-body injector in the household waste
- Your doctor, pharmacist or nurse will tell you how to return the full special disposal container.
There may be local guidelines for disposal

Skyrizi contains the active substance risankizumab.

Skyrizi is used to treat adult patients with moderate to severe Crohn’s disease.

How Skyrizi works

This medicine works by stopping a protein in the body called ‘IL-23’, which causes inflammation.

Crohn’s disease is an inflammatory disease of the digestive tract. If you have active Crohn’s disease you will first be given other medicines. If these medicines do not work well enough, you will be given Skyrizi to treat your Crohn’s disease.

Skyrizi reduces the inflammation and can therefore help to reduce the signs and symptoms of your disease.

You should not be given Skyrizi
- if you are allergic to risankizumab or any of the other ingredients of this medicine (listed in section 6).
- if you have an infection, including active tuberculosis, which your doctor thinks is important.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before and during the use of Skyrizi
- if you currently have an infection or if you have an infection that keeps coming back.
- if you have tuberculosis (TB).
- if you have recently received or plan to receive an immunisation (vaccine). You should not be given certain types of vaccines while using Skyrizi.

It is important that your doctor or nurse keep a record of the batch number of your Skyrizi.
Every time you get a new pack of Skyrizi, your doctor or nurse must note down the date and the batch number (which is on the packaging after “Lot”).

Serious allergic reactions
Skyrizi can cause serious side effects, including serious allergic reactions (‘anaphylaxis’).
Tell your doctor or seek medical help immediately if you notice any signs of an allergic reaction while you are taking Skyrizi such as:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- low blood pressure, which can cause dizziness or light-headedness
- severe itching of the skin, with a red rash or raised bumps

Children and adolescents
Skyrizi is not recommended for children and adolescents under 18 years of age. This is because the use of Skyrizi has not been confirmed in this age group.

Other medicines and Skyrizi
Tell your doctor, pharmacist or nurse
- if you are using, have recently used or might use any other medicines.
- if you have recently had or are going to have a vaccination. You should not be given certain types of vaccines while using Skyrizi.

If you are not sure, talk to your doctor, pharmacist or nurse before and during the use of Skyrizi.

Pregnancy, contraception and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. This is because it is not known how this medicine will affect the baby.

If you are a woman who can become pregnant, you should use contraception while using this medicine and for at least 21 weeks after your last dose of Skyrizi.

If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine.

Driving and using machines
Skyrizi is not likely to affect your driving and use of machines.

Skyrizi contains sorbitol, polysorbate and sodium
This medicine contains 164 mg sorbitol per 360 mg dose.

This medicine contains 0.8 mg of polysorbate 20 in each 360 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

This medicine contains less than 1 mmol sodium (23 mg) per 360 mg dose, that is to say essentially ‘sodium-free’.

You will begin treatment with Skyrizi with a starting dose which will be given by your doctor or nurse through a drip in your arm (intravenous infusion).

Starting doses

How much?
When?
Starting doses
600 mg
When your doctor tells you
600 mg
4 weeks after 1st dose
600 mg
4 weeks after 2nd dose

Afterwards, you will receive Skyrizi as an injection under your skin (called a ‘subcutaneous injection’) This will be given by your doctor or nurse as four injections under your skin as described below.
Alternatively Skyrizi may be administered by an on-body injector.

Maintenance doses

How much?
When?
1st maintenance dose
360 mg (4 injections of
90 mg)
4 weeks after the last starting dose
(at week 12)
Further doses
360 mg (4 injections of
90 mg)
Every 8 weeks, starting after the 1st maintenance dose

If you forget to use Skyrizi
If you forget or miss the appointment for any of your doses, contact your doctor to reschedule your appointment as soon as you remember.

If you stop using Skyrizi
Do not stop using Skyrizi without talking to your doctor first. If you stop treatment, your symptoms may come back.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Allergic reactions – these may need urgent treatment. Tell your doctor or get emergency medical help straight away if you notice any of the following signs:

Serious allergic reactions (‘anaphylaxis’) are rare in people taking Skyrizi (may affect up to 1 in a 1 000 people). Signs include:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- low blood pressure, which can cause dizziness or light-headedness

Talk to your doctor or get medical help immediately if you have the following symptoms.
Symptoms of a serious infection such as:
- fever, flu-like symptoms, night sweats
- feeling tired or short of breath, cough which will not go away
- warm, red and painful skin, or a painful skin rash with blisters

Your doctor will decide if you can keep using Skyrizi.

Other side effects
Tell your doctor, pharmacist or nurse if you get any of the following side effects

Very common: may affect more than 1 in 10 people
- upper respiratory infections with symptoms such as sore throat and stuffy nose

Common: may affect up to 1 in 10 people
- feeling tired
- fungal skin infection
- injection site reactions (such as redness or pain)
- itching
- headache
- rash
- eczema

Uncommon: may affect up to 1 in 100 people
- small raised red bumps on the skin
- hives (urticaria)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the syringe label and outer carton after ‘EXP’.

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled syringes in the original carton in order to protect from light.

Do not use this medicine if the liquid is cloudy or contains flakes or large particles.

Each pre-filled syringe is for single use only.

Do not throw away any medicines via wastewater or household waste. These measures will help protect the environment.

What Skyrizi contains
- The active substance is risankizumab. Each pre-filled syringe contains 90 mg of risankizumab in 1 mL solution.
- The other ingredients are disodium succinate hexahydrate, polysorbate 20, sorbitol, succinic acid and water for injections. See section 2, "Skyrizi contains sorbitol, polysorbate and sodium".

What Skyrizi looks like and contents of the pack
Skyrizi is a clear and colourless to slightly yellow liquid in a pre-filled syringe with needle guard. The liquid may contain tiny white or clear particles.

Each pack contains 4 pre-filled syringes.

Marketing Authorisation Holder

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer

AbbVie S.r.l.
04011 Campoverde di Aprilia
(Latina)
Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811
Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел: +359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel: +36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. z o.o.
Tel: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o.
Tel: +385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: +357 22 34 74 40

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.

---------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only

Traceability
In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.

Skyrizi pre-filled syringe

Plunger rod Finger grip Needle cover

Body of syringe

Instructions for use
This medicinal product should be administered by a healthcare professional.
Administer each pre-filled syringe subcutaneously as follows:

STEP 1

Before injecting, remove the carton from the refrigerator without removing the pre-filled syringes from the carton.

• Do not use this medicinal product if the carton seal is broken or missing, or if any of the components are damaged.

Allow Skyrizi to reach room temperature out of direct sunlight (15 to 30 minutes).

Do not shake the pre-filled syringes.

Place the following items on a clean, flat surface:
- 4 pre-filled syringes and 4 alcohol pads
(not included in the carton)
- 4 cotton balls or gauze pads (not included in the carton)
- Special disposal container (not included in the carton)

Wash and dry your hands.

For a full dose, 4 injections are required, one after the other.
STEP 2

Injectable areas
Choose an injection site.
- Inject one pre-filled syringe after the other in the following anatomic location(s):
o front of left thigh or right thigh

Injectable areas

o abdomen (belly) at least
5 cm from the navel (belly button)
- Use a new injection site for each injection.
- For each syringe, inject at least 3 cm away from the previous injection. Do not inject into the same place.

Before each injection, wipe where you will inject in a circular motion with an alcohol pad.
- Do not inject into areas where the skin is tender, bruised, erythematous, indurated or affected by any lesions.

STEP 3

Check liquid
Hold the syringe with the covered needle pointing down, as shown.

Check the liquid in the syringe.
- It is normal to see bubbles in the window
- The liquid should look clear to slightly yellow and may contain tiny white or clear particles
- Do not use if the liquid is cloudy or contains flakes or large particles

STEP 4

Removing the needle cover:

• Hold the syringe in one hand between the finger grip and needle cover
• With the other hand, gently pull the needle cover straight off
• Do not hold or pull the plunger rod when removing the needle cover
• You may see a drop of liquid at the end of the needle. This is normal
• Throw away the needle cover
• Do not touch the needle with your fingers or let the needle touch anything

STEP 5

Hold the body of the syringe in one hand between the thumb and index finger, like you would a pencil.

Gently pinch the area of cleaned skin with your other hand and hold it firmly.

Insert the needle all the way into the skin at about a 45-degree angle using a quick, short movement. Keep the syringe steady at the same angle.

Slowly push the plunger rod all the way in until all of the liquid is injected.

Pull the needle out of the skin while keeping the syringe at the same angle.

Slowly take your thumb off the plunger rod.
The needle will then be covered by the needle guard.

The needle guard will not activate unless all the liquid is injected.

Press a cotton ball or gauze pad where you have injected and hold for 10 seconds.

STEP 6

For a full dose, 4 injections are required

Use four 90 mg pre-filled syringes to subcutaneously administer the maintenance dose of 360 mg.
- Repeat Steps 2 through 5 with the subsequent syringes.

If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.

STEP 7

Each pre-filled syringe is for single use only and any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Skyrizi contains the active substance risankizumab.

Skyrizi is used to treat adult patients with:
- moderate to severe Crohn’s disease
- moderate to severe ulcerative colitis

How Skyrizi works

This medicine works by stopping a protein in the body called ‘IL-23’, which causes inflammation.

Crohn’s disease
Crohn’s disease is an inflammatory disease of the digestive tract. If you have active Crohn’s disease you will first be given other medicines. If these medicines do not work well enough, you will be given Skyrizi to treat your Crohn’s disease.

Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the large bowel. If you have active ulcerative colitis you will first be given other medicines. If these medicines do not work well enough or if you cannot take these medicines, you will be given Skyrizi to treat your ulcerative colitis.

Skyrizi reduces the inflammation and can therefore help to reduce the signs and symptoms of your disease.

Do not use Skyrizi
- if you are allergic to risankizumab or any of the other ingredients of this medicine (listed in section 6).

• if you have an infection, including active tuberculosis, which your doctor thinks is important.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before and during the use of Skyrizi
- if you currently have an infection or if you have an infection that keeps coming back.
- if you have tuberculosis (TB).
- if you have recently received or plan to receive an immunisation (vaccine). You should not be given certain types of vaccines while using Skyrizi.

It is important to keep a record of the batch number of your Skyrizi.
Every time you get a new pack of Skyrizi, note down the date and the batch number (which is on the packaging after “Lot”) and keep this information in a safe place.

Serious allergic reactions
Skyrizi can cause serious side effects, including serious allergic reactions (‘anaphylaxis’).
Tell your doctor or seek medical help immediately if you notice any signs of an allergic reaction while you are taking Skyrizi such as:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- low blood pressure, which can cause dizziness or light-headedness
- severe itching of the skin, with a red rash or raised bumps

Children and adolescents
Skyrizi is not recommended for children and adolescents under 18 years of age. This is because the use of Skyrizi has not been confirmed in this age group.

Other medicines and Skyrizi
Tell your doctor, pharmacist or nurse
- if you are using, have recently used or might use any other medicines.
- if you have recently had or are going to have a vaccination. You should not be given certain types of vaccines while using Skyrizi.

If you are not sure, talk to your doctor, pharmacist or nurse before and during the use of Skyrizi.

Pregnancy, contraception and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. This is because it is not known how this medicine will affect the baby.

If you are a woman who can become pregnant, you should use contraception while using this medicine and for at least 21 weeks after your last dose of Skyrizi.

If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine.

Driving and using machines
Skyrizi is not likely to affect your driving and use of machines.

Skyrizi contains polysorbate and sodium
This medicine contains 0.24 mg of polysorbate 20 in each dose 180 mg dose and 0.48 mg of polysorbate 20 in each 360 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

This medicine contains less than 1 mmol sodium (23 mg) per 180 mg dose and 360 mg dose, that is to say essentially ‘sodium-free’.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

This medicine is given as 1 or 2 injections under your skin (called ‘subcutaneous injections’).

How much Skyrizi to use

You will begin treatment with Skyrizi with a starting dose which will be given by your doctor or nurse through a drip in your arm (intravenous infusion).

Starting doses
Crohn’s disease
How much?
When?
600 mg
When your doctor tells you
600 mg
4 weeks after 1st dose
600 mg
4 weeks after 2nd dose

Ulcerative colitis
How much?
When?
1 200 mg
When your doctor tells you
1 200 mg
4 weeks after 1st dose
1 200 mg
4 weeks after 2nd dose

Afterwards, you will receive Skyrizi as an injection under your skin (called a ‘subcutaneous injection’)

Maintenance doses

Crohn’s disease
How much?
When?
1st maintenance dose
360 mg (2 injections of
180 mg)
4 weeks after the last starting dose
(at week 12)
Further doses
360 mg (2 injections of
180 mg)
Every 8 weeks, starting after the 1st maintenance dose

Ulcerative colitis
How much?
When?
1st maintenance dose
180 mg (1 injection of
180 mg) or 360 mg
(2 injections of 180 mg)
4 weeks after the last starting dose
(at week 12)
Further doses
180 mg (1 injection of
180 mg) or 360 mg
(2 injections of 180 mg)
Every 8 weeks, starting after the
1st maintenance dose

You and your doctor, pharmacist or nurse will decide if you should inject this medicine yourself. Do not inject yourself with this medicine unless you have been trained by your doctor, pharmacist or nurse. A caregiver may also give your injection after they have been trained.

Read section 7 ‘Instructions for use’ at the end of this leaflet before injecting Skyrizi yourself.

If you use more Skyrizi than you should
If you have used more Skyrizi than you should or the dose has been given sooner than prescribed, talk to your doctor.

If you forget to use Skyrizi
If you forget to use Skyrizi, inject a dose as soon as you remember. Talk to your doctor if you are not sure what to do.

If you stop using Skyrizi
Do not stop using Skyrizi without talking to your doctor first. If you stop treatment, your symptoms may come back.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Allergic reactions – these may need urgent treatment. Tell your doctor or get emergency medical help straight away if you notice any of the following signs:

Serious allergic reactions (‘anaphylaxis’) are rare in people taking Skyrizi (may affect up to 1 in a 1 000 people). Signs include:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue or throat
- low blood pressure, which can cause dizziness or light-headedness

Talk to your doctor or get medical help immediately if you have the following symptoms.
Symptoms of a serious infection such as:
- fever, flu-like symptoms, night sweats
- feeling tired or short of breath, cough which will not go away
- warm, red and painful skin, or a painful skin rash with blisters

Your doctor will decide if you can keep using Skyrizi.

Other side effects
Tell your doctor, pharmacist or nurse if you get any of the following side effects

Very common: may affect more than 1 in 10 people
- upper respiratory infections with symptoms such as sore throat and stuffy nose

Common: may affect up to 1 in 10 people
- feeling tired
- fungal skin infection
- injection site reactions (such as redness or pain)
- itching
- headache
- rash
- eczema

Uncommon: may affect up to 1 in 100 people
- small raised red bumps on the skin
- hives (urticaria)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the syringe label and outer carton after ‘EXP’.

Store in a refrigerator (2°C - 8°C). Do not freeze.

Keep the pre-filled syringe(s) in the original carton in order to protect from light.

If needed, you may also store the pre-filled syringe(s) out of the refrigerator (up to a maximum of 25°C) for up to 24 hours in the original carton to protect from light.

Do not use this medicine if the liquid is cloudy or contains flakes or large particles.

Each pre-filled syringe is for single use only.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Skyrizi contains
- The active substance is risankizumab. Each pre-filled syringe contains 180 mg of risankizumab in 1.2 mL solution.
- The other ingredients are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20 and water for injections. See section 2, "Skyrizi contains polysorbate and sodium".

What Skyrizi looks like and contents of the pack
Skyrizi is a clear and colourless to yellow liquid in a pre-filled syringe with needle guard. The liquid may contain tiny white or clear particles.

Each pack contains 1 or 2 pre-filled syringes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer

AbbVie Biotechnology GmbH
Knollstrasse
67061 Ludwigshafen
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811
Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел: +359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel: +36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. z o.o.
Tel: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o.
Tel: +385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd

Sverige
AbbVie AB

Τηλ: +357 22 34 74 40
Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

Detailed and updated information on this product is available by scanning the QR code included below or on the outer carton with a smartphone. The same information is also available at the following URL:
www.skyrizi.eu

QR code to be included

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.

---------------------------------------------------------------------------------------------------------------------------

7.
Instructions for use

Please read all of section 7 before using Skyrizi

Skyrizi pre-filled syringe

Plunger rod Finger grip Needle cover

Body of syringe

Important information to know before you inject Skyrizi
- You should receive training on how to inject Skyrizi before giving an injection. Talk to your doctor, pharmacist or nurse if you need help
- Mark the dates on your calendar so you know when to inject Skyrizi
- Keep Skyrizi in the original carton to protect the medicine from light until it is time to use it
- Do not inject if the liquid is cloudy or contains flakes or large particles. The liquid should look clear to yellow and may contain tiny white or clear particles
- Do not shake the syringe(s)

• Wait to remove the needle cover until just before the injection

Return this medicine to the pharmacy
- if the expiry date (EXP) has passed
- if the liquid has ever been frozen (even if thawed)
- if the syringe has been dropped or damaged
- if the carton perforations are broken

For a more comfortable injection: Take the carton out of the refrigerator and leave it at room temperature, out of direct sunlight, for 15 to 30 minutes before injecting.
- Skyrizi should not be warmed in any other way (for example, in a microwave or in hot water)
- Keep the syringe in the carton until ready to inject

Follow the steps below each time you use Skyrizi

STEP 1

180 mg dose – 1 syringe

360 mg dose – 2 syringes

Place the following items on a clean, flat surface:

• 1 or 2 pre-filled syringe(s) and 1 or 2 alcohol pad(s) (not included in the carton)
• 1 or 2 cotton ball(s) or gauze pad(s) (not included in the carton)
• Special disposal container (not included in the carton)

Wash and dry your hands.

For the 180 mg dose

1 injection is required.

For the 360 mg dose

2 injections are required, one after the other.

Start with one syringe for the first injection.

STEP 2

Areas to inject

Areas to inject

Choose from these 3 areas to inject:
- front of left thigh
- front of right thigh
- belly (abdomen) at least 5 cm from the belly button (navel)

Before injecting, wipe where you will inject in a circular motion with an alcohol pad.
- Do not touch or blow on the injection site after it is cleaned. Allow the skin to dry before injecting.
- Do not inject through clothes
- Do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks.

For the 360 mg dose
- Use a new injection site for each injection.
- For the second syringe, inject at least 3 cm away from the first injection. Do not inject into the same place.

STEP 3

Check liquid
Hold the syringe with the covered needle pointing down, as shown.

Check the liquid in the syringe.
- It is normal to see bubbles in the window
- The liquid should look clear to yellow and may contain tiny white or clear particles
- Do not use if the liquid is cloudy or contains flakes or large particles

STEP 4

Removing the needle cover:

• Hold the syringe in one hand between the finger grip and needle cover
• With the other hand, gently pull the needle cover straight off
• Do not hold or pull the plunger rod when removing the needle cover
• You may see a drop of liquid at the end of the needle. This is normal
• Throw away the needle cover
• Do not touch the needle with your fingers or let the needle touch anything

STEP 5

Hold the body of the syringe in one hand between the thumb and index finger, like you would a pencil.

Gently pinch the area of cleaned skin with your other hand and hold it firmly.

Insert the needle all the way into the skin at about a
45-degree angle using a quick, short movement. Keep the syringe steady at the same angle.

STEP 6

Needle guard
Slowly push the plunger rod all the way in until all of the liquid is injected.

Pull the needle out of the skin while keeping the syringe at the same angle.

Slowly take your thumb off the plunger rod. The needle will then be covered by the needle guard.

• The needle guard will not activate unless all the liquid is injected.
• Speak to your doctor, pharmacist or nurse if you think you have not given a full dose.

Press a cotton ball or gauze pad where you have injected and hold for 10 seconds.

Do not rub the skin where you have injected. You may have slight bleeding from where you injected.
This is normal.
STEP 7

180 mg dose

1 injection is required

360 mg dose

2 injections are required

For the 180 mg dose
1 injection is required.

For the 360 mg dose
2 injections are required
- Repeat Steps 2 through 6 with the second syringe.
- Inject the second syringe straight after the first injection but at least 3 cm away from the first injection.

STEP 8

Throw away used syringes in a special disposal container right away after use.
- Do not throw away used syringes in the household waste
- Your doctor, pharmacist or nurse will tell you how to return the full special disposal container