evolocumab: package leaflet

What Repatha is and how it works

Repatha is a medicine that lowers levels of ‘bad’ cholesterol, a type of fat, in the blood.

Repatha contains the active substance evolocumab, a monoclonal antibody (a type of specialised protein designed to attach to a target substance in the body). Evolocumab is designed to attach to a substance called PCSK9 that affects the liver’s ability to take in cholesterol. By attaching to, and mopping up PCSK9, the medicine increases the amount of cholesterol entering the liver and so lowers the level of cholesterol in the blood.

What Repatha is used for

Repatha is used in addition to your cholesterol lowering diet if you are:
- an adult with a high cholesterol level in your blood (pr imary hypercholesterolaemia [heterozygous familial and non-familial] or mixed dyslipidaemia). It is given:
- together with a statin or other cholesterol lowering medication, if the maximum dose of a statin does not lower levels of cholesterol sufficiently.
- alone or together with other cholesterol lowering medications when statins do not work well or cannot be used.
- a child aged 10 years and older with a high cholesterol level in your blood because of a condition that runs in your family (heterozygous familial hypercholesterolaemia or HeFH). It is given alone or together with other cholesterol lowering treatments

- an adult or a child aged 10 years and older with a high cholesterol level in your blood because of a condition that runs in your family (homozygous familial hypercholesterolaemia or HoFH).
It is given together with other cholesterol lowering treatments
- an adult with a high cholesterol level in your blood, who already has atherosclerotic cardiovascular disease or at high risk for developing a cardiovascular event. It is given:
- together with a statin or other cholesterol lowering medication, if the maximum dose of a statin does not lower levels of cholesterol sufficiently.
- alone or together with other cholesterol lowering medications when statins do not work well or cannot be used.

Repatha is used in patients who cannot control their cholesterol levels with a cholesterol lowering diet alone. You should stay on your cholesterol lowering diet while taking this medicine. In patients who are at high risk of a cardiovascular event, Repatha can help prevent heart attack, stroke, and certain heart procedures to restore blood flow to the heart due to a build-up of fatty deposits in your arteries (also known as atherosclerotic cardiovascular disease).

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Repatha if you have liver disease.

The needle cover of the glass pre-filled syringe is made from dry natural rubber (a derivative of latex), which may cause severe allergic reactions.

In order to improve the traceability of this medicine, your doctor or pharmacist should record the name and the lot number of the product you have been given in your patient file. You may also wish to make a note of these details in case you are asked for this information in the future.

Children and adolescents

The use of Repatha has been studied in children 10 years of age and older being treated for heterozygous or homozygous familial hypercholesterolaemia.

The use of Repatha has not been studied in children under 10 years of age.

Other medicines and Repatha

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Repatha has not been tested in pregnant women. It is not known if Repatha will harm your unborn baby.

It is not known whether Repatha is found in breast milk.

It is important to tell your doctor if you are breast-feeding or plan to do so. Your doctor will then help you decide whether to stop breast-feeding, or whether to stop taking Repatha, considering the benefit of breast-feeding to the baby and the benefit of Repatha to the mother.

Driving and using machines

Repatha has no or negligible influence on the ability to drive and use machines.

Repatha contains sodium

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

Repatha contains proline

This medicine contains 25 mg of proline in each 1.0 mL of 140 mg/mL evolocumab. Proline may be harmful for patients with hyperprolinaemia, a rare genetic disorder in which proline builds up in the body. If you (or your child) have hyperprolinaemia, do not use this medicine unless your doctor has recommended it.

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

The recommended dose depends on the underlying condition:
- for adults with primary hypercholesterolaemia and mixed dyslipidaemia the dose is either 140 mg every two weeks or 420 mg once monthly.
- for children aged 10 years or older with heterozygous familial hypercholesterolaemia the dose is either 140 mg every two weeks or 420 mg once monthly.
- for adults or children aged 10 years or older with homozygous familial hypercholesterolaemia the recommended starting dose is 420 mg once monthly. After 12 weeks your doctor may decide to increase the dose to 420 mg every two weeks. If you also receive apheresis, a procedure similar to dialysis where cholesterol and other fats are removed from the blood, your doctor may decide to start you on a dose of 420 mg every two weeks to coincide with your apheresis treatment.
- for adults with established atherosclerotic cardiovascular disease or at high risk for developing a cardiovascular event, the dose is either 140 mg every two weeks or 420 mg once monthly.

Repatha is given as an injection under the skin (subcutaneous).

If your doctor prescribes a dose of 420 mg you must use three pre-filled syringes because each pre-filled syringe only contains 140 mg of medicine. After reaching room temperature, all injections should be given within a 30 minute period.

If your doctor decides that you or a caregiver can give the injections of Repatha, you or your caregiver should receive training on how to prepare and inject Repatha correctly. Do not try to inject Repatha until you have been shown how to do it by your doctor or nurse.

See the detailed “Instructions for Use” at the end of this leaflet for instructions about how to store, prepare, and give your Repatha injections at home.

Before starting Repatha, you should be on a diet to lower your cholesterol. You should keep on this cholesterol lowering diet while taking Repatha.

If your doctor has prescribed Repatha along with another cholesterol lowering medicine, follow your doctor’s instructions on how to take these medicines together. In this case, please read the dosage instructions in the package leaflet of that particular medicine as well.

If you use more Repatha than you should

Contact your doctor or pharmacist immediately.

If you forget to take Repatha

Take Repatha as soon as you can after the missed dose. Then, contact your doctor who will tell you when you should schedule your next dose, and follow the new schedule exactly as your doctor has told you.

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

Common (may affect up to 1 in 10 people)
- Flu (high temperature, sore throat, runny nose, cough and chills)
- Common cold, such as runny nose, sore throat or sinus infections (nasopharyngitis or upper respiratory tract infections)
- Feeling sick (nausea)
- Back pain
- Joint pain (arthralgia)
- Muscle pain
- Injection site reactions, such as bruising, redness, bleeding, pain or swelling
- Allergic reactions including rash
- Headache

Uncommon (may affect up to 1 in 100 people)
- Hives, red itchy bumps on your skin (urticaria)
- Flu-like symptoms

Rare (may affect up to 1 in 1 000 people)
- Swelling of the face, mouth, tongue, or throat (angioedema)

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 label and carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C). Do not freeze.
Store in the original carton in order to protect from light.

Your pre-filled syringe may be left outside the refrigerator to reach room temperature (up to 25°C) before injection. This will make the injection more comfortable. After removal from the refrigerator, Repatha may be stored at room temperature (up to 25°C) in the original carton and must be used within 1 month.

Do not use this medicine if you notice it is discoloured or contains large lumps, flakes or coloured 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 Repatha contains
- The active substance is evolocumab. Each pre-filled syringe contains 140 mg of evolocumab in 1 mL of solution.
- The other ingredients are proline, glacial acetic acid, polysorbate 80, sodium hydroxide, water for injections.

What Repatha looks like and contents of the pack

Repatha is a solution which is clear to opalescent, colourless to yellowish, and practically free from particles.

Each pack contains one single use pre-filled syringe.

Marketing Authorisation Holder and Manufacturer
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands

Marketing Authorisation Holder
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands

Manufacturer
Amgen Technology (Ireland) Unlimited Company
Pottery Road
Dun Laoghaire
Co Dublin
Ireland

Manufacturer
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium

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

België/Belgique/Belgien s.a. Amgen n.v.
Tel/Tél: +32 (0)2 7752711

Lietuva
Amgen Switzerland AG Vilniaus filialas
Tel. +370 5 219 7474

България
Амджен България ЕООД
Тел.: +359 (0)2 424 7440

Luxembourg/Luxemburg s.a. Amgen
Belgique/Belgien
Tel/Tél: +32 (0)2 7752711

Česká republika
Amgen s.r.o.
Tel: +420 221 773 500

Magyarország
Amgen Kft.
Tel.: +36 1 35 44 700

Danmark
Amgen, filial af Amgen AB, Sverige
Tlf.: +45 39617500

Malta
Amgen S.r.l.
Italy
Tel: +39 02 6241121

Deutschland
Amgen GmbH
Tel.: +49 89 1490960

Nederland
Amgen B.V.
Tel: +31 (0)76 5732500

Eesti
Amgen Switzerland AG Vilniaus filialas
Tel: +372 586 09553

Norge
Amgen AB
Tlf: +47 23308000

Ελλάδα
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.
Τηλ: +30 210 3447000

Österreich
Amgen GmbH
Tel: +43 (0)1 50 217

España
Amgen S.A.
Tel: +34 93 600 18 60

Polska
Amgen Biotechnologia Sp. z o.o.
Tel.: +48 22 581 3000

France
Amgen S.A.S.
Tél: +33 (0)9 69 363 363

Portugal
Amgen Biofarmacêutica, Lda.
Tel: +351 21 4220606

Hrvatska
Amgen d.o.o.
Tel: +385 (0)1 562 57 20

România
Amgen România SRL
Tel: +4021 527 3000

Ireland
Amgen Ireland Limited
Tel: +353 1 8527400

Slovenija
AMGEN zdravila d.o.o.
Tel: +386 (0)1 585 1767

Ísland
Vistor
Sími: +354 535 7000

Slovenská republika
Amgen Slovakia s.r.o.
Tel: +421 2 321 114 49

Italia
Amgen S.r.l.
Tel: +39 02 6241121

Suomi/Finland
Amgen AB, sivuliike Suomessa/Amgen AB, filial i Finland
Puh/Tel: +358 (0)9 54900500

Kύπρος
C.A. Papaellinas Ltd
Τηλ: +357 22741 741

Sverige
Amgen AB
Tel: +46 (0)8 6951100

Latvija
Amgen Switzerland AG Rīgas filiāle
Tel: +371 257 25888

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.

__________________________________________________________________________________

Instructions for use:
Repatha single use pre-filled syringe

Guide to parts
Before use
After use
Plunger rod
Medicine
Syringe barrel
Grey needle cap on

Used plunger

Used syringe barrel

Used
Needle

Needle is inside.

Grey needle cap off

Important
Before you use a single use Repatha pre-filled syringe, read this important information:
- Do not try to give the injection until you have fully read and understood these instructions for use.
Do not freeze or use the Repatha pre-filled syringe if it has been frozen.
- Do not use the Repatha pre-filled syringe if the packaging is open or damaged.
- Do not use the Repatha pre-filled syringe if it has been dropped onto a hard surface. Part of the syringe may be broken even if you cannot see the break. Use a new Repatha pre-filled syringe.
- Do not remove the grey needle cap from the Repatha pre-filled syringe until you are ready to inject.

Step 1: Prepare
A
Remove the Repatha pre-filled syringe carton from the refrigerator and wait 30 minutes.
Wait at least 30 minutes for the pre-filled syringe in the carton to naturally reach room temperature before injecting.
Check that the name Repatha appears on the carton label.
- Do not try to warm the Repatha pre-filled syringe by using a heat source such as hot water or microwave.
- Do not leave the Repatha pre-filled syringe exposed to direct sunlight.
- Do not shake the Repatha pre-filled syringe.

C
Choose your injection site.

Upper arm

Stomach area (abdomen)

Thigh
You can use:
- Thigh.
- Stomach area (abdomen), except for the 2 inches (5 centimetres) around the belly button.
- Outer area of upper arm (only if someone else is giving you the injections).
- Do not choose an area where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.
Choose a different site each time you give yourself an injection. If you need to use the same injection site, just make sure it is not the same spot on that site you used last time.

B
Gather all materials needed for your injection.
Wash your hands thoroughly with soap and water.
On a clean, well-lit, flat work surface, place:
- One Repatha pre-filled syringe in its tray.
- Alcohol wipes.
- Cotton ball or gauze pad.
- Plaster.
- Sharps disposal container.
- Do not use if expiry date on the Repatha pre-filled syringe carton has passed.

D
Clean your injection site.
Clean your injection site with an alcohol wipe. Let your skin dry before injecting.
- Do not touch this area of skin again before injecting.

E
Remove the pre-filled syringe from the tray.
Turn tray over
Gently Press

To remove:

Peel the paper off of the tray.

Place the tray on your hand.

Turn the tray over and gently press the middle of the tray’s back to release the syringe into your palm.

If the pre-filled syringe does not release from the tray, gently press on the back of tray.
- Do not pick up or pull the pre-filled syringe by the plunger rod or grey needle cap. This could damage the syringe.
- Do not remove the grey needle cap from the pre-filled syringe until you are ready to inject.

Always hold the pre-filled syringe by the syringe barrel.

F
Inspect medicine and syringe.
Plunger rod

Syringe barrel

Syringe label with expiration date
Grey needle cap on
Medicine
Always hold the pre-filled syringe by the syringe barrel.
Check that:

The name Repatha appears on the pre-filled syringe label.

The medicine in the pre-filled syringe is clear and colourless to slightly yellow.

Do not use the pre-filled syringe if any part of the pre-filled syringe appears cracked or broken.

Do not use the pre-filled syringe if the grey needle cap is missing or not securely attached.

Do not use the pre-filled syringe if the medicine is discoloured or contains large lumps, flakes or coloured particles.

Do not use the pre-filled syringe if the expiration date on the pre-filled syringe has passed.

Step 2: Get ready
A
Carefully pull the grey needle cap straight out and away from your body. Do not leave the grey needle cap off for more than 5 minutes. This can dry out the medicine.
1.

2.

It is normal to see a drop of medicine at the end of the needle.

Immediately place the cap in the sharps disposal container.
- Do not twist or bend the grey needle cap. This can damage the needle.
- Do not put the grey needle cap back onto the pre-filled syringe.

B
Remove the air bubble/gap.
You may notice an air bubble/gap in the Repatha pre-filled syringe.
If you notice an air bubble/gap:
- Hold the pre-filled syringe with the needle facing up.
- Gently tap the syringe barrel with your fingers until the air bubble/gap rises to the top of the syringe.
- Slowly and gently push the plunger rod up to get the air out of the pre-filled syringe. Be very careful not to push out any medicine.

• Do not tap the syringe needle.

C
PINCH your injection site to create a firm surface.

Pinch skin firmly between your thumb and fingers, creating an area about 2 inches (5 centimetres) wide.
It is important to keep the skin pinched while injecting.

Step 3: Inject
A
Hold the PINCH. Insert the needle into the skin using a 45 to 90 degree angle.
- Do not place your finger on the plunger rod while inserting the needle.

B
Using slow and constant pressure, PUSH the plunger rod all the way down until the syringe is empty.

C
When done, RELEASE your thumb, and gently lift the syringe off skin.
- Do not put the grey needle cap back onto the used syringe.

Step 4: Finish
A
Immediately place the used syringe in a sharps disposal container.
Talk with your healthcare provider about proper disposal. There may be local guidelines for disposal.
- Do not reuse the used syringe.
- Do not use any medicine that is left in the used syringe.
- Do not recycle the syringe or the sharps disposal container or throw it into household rubbish.
Keep the used syringe and sharps container out of the sight and reach of children.

B
Examine the injection site.
If there is blood, press a cotton ball or gauze pad on your injection site. Apply a plaster if needed.
- Do not rub the injection site.

What Repatha is and how it works

Repatha is a medicine that lowers levels of ‘bad’ cholesterol, a type of fat, in the blood.

Repatha contains the active substance evolocumab, a monoclonal antibody (a type of specialised protein designed to attach to a target substance in the body). Evolocumab is designed to attach to a substance called PCSK9 that affects the liver’s ability to take in cholesterol. By attaching to, and mopping up PCSK9, the medicine increases the amount of cholesterol entering the liver and so lowers the level of cholesterol in the blood.

What Repatha is used for

Repatha is used in addition to your cholesterol lowering diet if you are:
- an adult with a high cholesterol level in your blood (primary hypercholesterolaemia [heterozygous familial and non-familial] or mixed dyslipidaemia). It is given:
- together with a statin or other cholesterol lowering medication, if the maximum dose of a statin does not lower levels of cholesterol sufficiently.
- alone or together with other cholesterol lowering medications when statins do not work well or cannot be used.
- a child aged 10 years and older with a high cholesterol level in your blood because of a condition that runs in your family (heterozygous familial hypercholesterolaemia or HeFH). It is given alone or together with other cholesterol lowering treatments.

- an adult or a child aged 10 years and older with a high cholesterol level in your blood because of a condition that runs in your family (homozygous familial hypercholesterolaemia or HoFH).
It is given together with other cholesterol lowering treatments.
- an adult with a high cholesterol level in your blood, who already has atherosclerotic cardiovascular disease or at high risk for developing a cardiovascular event. It is given:
- together with a statin or other cholesterol lowering medication, if the maximum dose of a statin does not lower levels of cholesterol sufficiently.
- alone or together with other cholesterol lowering medications when statins do not work well or cannot be used.

Repatha is used in patients who cannot control their cholesterol levels with a cholesterol lowering diet alone. You should stay on your cholesterol lowering diet while taking this medicine. In patients who are at high risk for developing a cardiovascular event, Repatha can help prevent heart attack, stroke, and certain heart procedures to restore blood flow to the heart due to a build-up of fatty deposits in your arteries (also known as atherosclerotic cardiovascular disease).

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Repatha if you have liver disease.

In order to improve the traceability of this medicine, your doctor or pharmacist should record the name and the lot number of the product you have been given in your patient file. You may also wish to make a note of these details in case you are asked for this information in the future.

Children and adolescents

The use of Repatha has been studied in children 10 years of age and older being treated for heterozygous or homozygous familial hypercholesterolaemia.

The use of Repatha has not been studied in children under 10 years of age.

Other medicines and Repatha

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Repatha has not been tested in pregnant women. It is not known if Repatha will harm your unborn baby.

It is not known whether Repatha is found in breast milk.

It is important to tell your doctor if you are breast-feeding or plan to do so. Your doctor will then help you decide whether to stop breast-feeding, or whether to stop taking Repatha, considering the benefit of breast-feeding to the baby and the benefit of Repatha to the mother.

Driving and using machines

Repatha has no or negligible influence on the ability to drive and use machines.

Repatha contains sodium

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

Repatha contains proline

This medicine contains 25 mg of proline in each 1.0 mL of 140 mg/mL evolocumab. Proline may be harmful for patients with hyperprolinaemia, a rare genetic disorder in which proline builds up in the body. If you (or your child) have hyperprolinaemia, do not use this medicine unless your doctor has recommended it.

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

The recommended dose depends on the underlying condition:
- for adults with primary hypercholesterolaemia and mixed dyslipidaemia the dose is either 140 mg every two weeks or 420 mg once monthly.
- for children aged 10 years or older with heterozygous familial hypercholesterolaemia the dose is either 140 mg every two weeks or 420 mg once monthly.
- for adults or children aged 10 years or older with homozygous familial hypercholesterolaemia the recommended starting dose is 420 mg once monthly. After 12 weeks your doctor may decide to increase the dose to 420 mg every two weeks. If you also receive apheresis, a procedure similar to dialysis where cholesterol and other fats are removed from the blood, your doctor may decide to start you on a dose of 420 mg every two weeks to coincide with your apheresis treatment.
- for adults with established atherosclerotic cardiovascular disease or at high risk for developing a cardiovascular event, the dose is either 140 mg every two weeks or 420 mg once monthly.

Repatha is given as an injection under the skin (subcutaneous).

If your doctor prescribes a dose of 420 mg you must use three pre-filled pens because each pre-filled pen only contains 140 mg of medicine. After reaching room temperature, all injections should be given within a 30 minute period.

If your doctor decides that you or a caregiver can give the injections of Repatha, you or your caregiver should receive training on how to prepare and inject Repatha correctly. Do not try to inject Repatha until you have been shown how to do it by your doctor or nurse.

See the detailed “Instructions for Use” at the end of this leaflet for instructions about how to store, prepare, and give your Repatha injections at home. If using the pre-filled pen, place the correct (yellow) end of the pen on the skin before injecting.

Before starting Repatha, you should be on a diet to lower your cholesterol. You should keep on this cholesterol lowering diet while taking Repatha.

If your doctor has prescribed Repatha along with another cholesterol lowering medicine, follow your doctor’s instructions on how to take these medicines together. In this case, please read the dosage instructions in the package leaflet of that particular medicine as well.

If you use more Repatha than you should

Contact your doctor or pharmacist immediately.

If you forget to take Repatha

Take Repatha as soon as you can after the missed dose. Then, contact your doctor who will tell you when you should schedule your next dose, and follow the new schedule exactly as your doctor has told you.

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

Common (may affect up to 1 in 10 people)
- Flu (high temperature, sore throat, runny nose, cough and chills)
- Common cold, such as runny nose, sore throat or sinus infections (nasopharyngitis or upper respiratory tract infections)
- Feeling sick (nausea)
- Back pain
- Joint pain (arthralgia)
- Muscle pain
- Injection site reactions, such as bruising, redness, bleeding, pain or swelling
- Allergic reactions including rash
- Headache

Uncommon (may affect up to 1 in 100 people)
- Hives, red itchy bumps on your skin (urticaria)
- Flu-like symptoms

Rare (may affect up to 1 in 1 000 people)
- Swelling of the face, mouth, tongue, or throat (angioedema)

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 label and carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C). Do not freeze.
Store in the original carton in order to protect from light.

Your pre-filled pen may be left outside the refrigerator to reach room temperature (up to 25°C) before injection. This will make the injection more comfortable. After removal from the refrigerator, Repatha may be stored at room temperature (up to 25°C) in the original carton and must be used within 1 month.

Do not use this medicine if you notice it is discoloured or contains large lumps, flakes or coloured 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 Repatha contains
- The active substance is evolocumab. Each SureClick pre-filled pen contains 140 mg of evolocumab in 1 mL of solution.
- The other ingredients are proline, glacial acetic acid, polysorbate 80, sodium hydroxide, water for injections.

What Repatha looks like and contents of the pack

Repatha is a solution which is clear to opalescent, colourless to yellowish, and practically free from particles.

Each pack contains one, two, three or six single use SureClick pre-filled pens.

Marketing Authorisation Holder and Manufacturer
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands

Marketing Authorisation Holder
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands

Manufacturer
Amgen Technology (Ireland) Unlimited Company
Pottery Road
Dun Laoghaire
Co Dublin
Ireland

Manufacturer
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium

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

België/Belgique/Belgien s.a. Amgen n.v.
Tel/Tél: +32 (0)2 7752711

Lietuva
Amgen Switzerland AG Vilniaus filialas
Tel. +370 5 219 7474

България
Амджен България ЕООД
Тел.: +359 (0)2 424 7440

Luxembourg/Luxemburg s.a. Amgen
Belgique/Belgien
Tel/Tél: +32 (0)2 7752711

Česká republika
Amgen s.r.o.
Tel: +420 221 773 500

Magyarország
Amgen Kft.
Tel.: +36 1 35 44 700

Danmark
Amgen, filial af Amgen AB, Sverige
Tlf.: +45 39617500

Malta
Amgen S.r.l.
Italy
Tel: +39 02 6241121

Deutschland
Amgen GmbH
Tel.: +49 89 1490960

Nederland
Amgen B.V.
Tel: +31 (0)76 5732500

Eesti
Amgen Switzerland AG Vilniaus filialas
Tel: +372 586 09553

Norge
Amgen AB
Tlf: +47 23308000

Ελλάδα
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.
Τηλ: +30 210 3447000

Österreich
Amgen GmbH
Tel: +43 (0)1 50 217

España
Amgen S.A.
Tel: +34 93 600 18 60

Polska
Amgen Biotechnologia Sp. z o.o.
Tel.: +48 22 581 3000

France
Amgen S.A.S.
Tél: +33 (0)9 69 363 363

Portugal
Amgen Biofarmacêutica, Lda.
Tel: +351 21 4220606

Hrvatska
Amgen d.o.o.
Tel: +385 (0)1 562 57 20

România
Amgen România SRL
Tel: +4021 527 3000

Ireland
Amgen Ireland Limited
Tel: +353 1 8527400

Slovenija
AMGEN zdravila d.o.o.
Tel: +386 (0)1 585 1767

Ísland
Vistor
Sími: +354 535 7000

Slovenská republika
Amgen Slovakia s.r.o.
Tel: +421 2 321 114 49

Italia
Amgen S.r.l.
Tel: +39 02 6241121

Suomi/Finland
Amgen AB, sivuliike Suomessa/Amgen AB, filial i Finland
Puh/Tel: +358 (0)9 54900500

Kύπρος
C.A. Papaellinas Ltd
Τηλ: +357 22741 741

Sverige
Amgen AB
Tel: +46 (0)8 6951100

Latvija
Amgen Switzerland AG Rīgas filiāle
Tel: +371 257 25888

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.

__________________________________________________________________________________

Instructions for use:
Repatha single use SureClick pre-filled pen

Guide to parts
Before use
After use
Grey start button
Expiry date
Window
Medicine
Orange cap on

Yellow safety guard
(needle inside)

Expiry date

Yellow window
(injection complete)
Yellow safety guard
(needle inside)
Orange cap off

Important: Needle is inside the yellow safety guard.

Important
Before you use the Repatha pre-filled pen, read this important information:
- Do not try to give the injection until you have fully read and understood these instructions for use.
- Do not freeze or use the Repatha pre-filled pen if it has been frozen.
- Do not remove the orange cap from the Repatha pre-filled pen until you are ready to inject.
- Do not use the Repatha pre-filled pen if it has been dropped on a hard surface. Part of the Repatha pre-filled pen may be broken even if you cannot see the break.

B
Inspect the Repatha pre-filled pen.
Yellow safety guard
(needle inside)
Orange cap on
Window
Medicine
Make sure the medicine in the window is clear and colourless to slightly yellow.
Check the expiration date.
- Do not use the pre-filled pen if medicine is cloudy or discoloured or contains large lumps, flakes, or particles.
- Do not use the pre-filled pen if any part appears cracked or broken.
- Do not use if the pre-filled pen has been dropped.
- Do not use the pre-filled pen if the orange cap is missing or not securely attached.
- Do not use the pre-filled pen if the expiration date has passed.
In all cases, use a new pre-filled pen.

Step 1: Prepare
A
Remove one Repatha pre-filled pen from the package.
1.
Carefully lift the pre-filled pen straight up out of the box.
2.
Put the original package with any unused pre-filled pens back in the refrigerator.
3.
Wait at least 30 minutes for the pre-filled pen to naturally reach room temperature before injecting.

Do not try to warm the pre-filled pen by using a heat source such as hot water or microwave.

Do not leave the pre-filled pen in direct sunlight.

Do not shake the pre-filled pen.

Do not remove the orange cap from the pre-filled pen yet.

C
Gather all materials needed for your injection.
Wash your hands thoroughly with soap and water.
On a clean, well-lit work surface, place the:

New pre-filled pen.

Alcohol wipes.

Cotton ball or gauze pad.

Plaster.

Sharps disposal container.

D
Prepare and clean your injection site.

Upper arm
Stomach area (abdomen)
Thigh
Only use these injection sites:

Thigh.

Stomach area (abdomen), except for a 2 inches (5 centimetres) area around your belly button.

Outer area of upper arm (only if someone else is giving you the injection).
Clean the injection site with an alcohol wipe. Let your skin dry.

Do not touch this area again before injecting.

Choose a different site each time you give yourself an injection. If you need to use the same injection site, just make sure it is not the same spot on that site you used last time.

Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.

Step 2: Get ready
A
Pull the orange cap straight off, only when you are ready to inject. Do not leave the orange cap off for more than 5 minutes. This can dry out the medicine.

Orange cap

It is normal to see a drop of liquid at the end of the needle or yellow safety guard.

Do not twist, bend or wiggle the orange cap.

Do not put the orange cap back onto the pre-filled pen.

Do not put fingers into the yellow safety guard.

Important: Do not remove the orange cap from the pre-filled pen until you are ready to inject.
If you are unable to inject, please contact your healthcare provider.

B
Create a firm surface at the selected injection site (thigh, stomach, or outer areas of the upper arm), by using either the stretch method or the pinch method.
Stretch method

Stretch the skin firmly by moving your thumb and fingers in the opposite direction, creating an area about 2 inches (5 centimetres) wide.
OR
Pinch method

Pinch the skin firmly between your thumb and fingers, creating an area about 2 inches (5 centimetres) wide.

Important: It is important to keep skin stretched or pinched while injecting.

Step 3: Inject
A
Keep holding the stretched or pinched skin. With the orange cap off, put the yellow safety guard on your skin at 90 degrees. The needle is inside the yellow safety guard.
Do not touch the grey start button yet.

Yellow Safety Guard
(needle inside)

B
Firmly push down the pre-filled pen onto the skin until it stops moving.

Important: You must push all the way down but do not touch the grey start button until you are ready to inject.

C
When you are ready to inject, press the grey start button. You will hear a click.

“click”

D
Keep pushing down on the skin. Then lift your thumb while still holding the pre-filled pen on your skin. Your injection could take about 15 seconds.

“click”

15 seconds

Window turns from clear to yellow when the injection is done. You may hear a second click.

NOTE: After you remove the pre-filled pen from your skin, the needle will be automatically covered.

Step 4: Finish
A
Discard the used pre-filled pen and orange needle cap.

Discard the used pre-filled pen and the orange cap in a sharps disposal container.
Talk with your healthcare provider about proper disposal. There may be local guidelines for disposal.
Keep the pre-filled pen and the sharps disposal container out of the sight and reach of children.

Do not reuse the pre-filled pen.

Do not recap the pre-filled pen or put fingers into the yellow safety guard.

Do not recycle the pre-filled pen or sharps disposal container or throw them into household rubbish.

B
Examine the injection site.
If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site.
Apply a plaster if needed.

What Repatha is and how it works

Repatha is a medicine that lowers levels of ‘bad’ cholesterol, a type of fat, in the blood.

Repatha contains the active substance evolocumab, a monoclonal antibody (a type of specialised protein designed to attach to a target substance in the body). Evolocumab is designed to attach to a substance called PCSK9 that affects the liver’s ability to take in cholesterol. By attaching to, and mopping up PCSK9, the medicine increases the amount of cholesterol entering the liver and so lowers the level of cholesterol in the blood.

What Repatha is used for

Repatha is used in addition to your cholesterol lowering diet if you are:
- an adult with a high cholesterol level in your blood (primary hypercholesterolaemia [heterozygous familial and non-familial] or mixed dyslipidaemia). It is given:
- together with a statin or other cholesterol lowering medication, if the maximum dose of a statin does not lower levels of cholesterol sufficiently.
- alone or together with other cholesterol lowering medications when statins do not work well or cannot be used.
- a child aged 10 years and older with a high cholesterol level in your blood because of a condition that runs in your family (heterozygous familial hypercholesterolaemia or HeFH). It is given alone or together with other cholesterol lowering treatments

- an adult or a child aged 10 years and older with a high cholesterol level in your blood because of a condition that runs in your family (homozygous familial hypercholesterolaemia or HoFH).
It is given together with other cholesterol lowering treatments.
- an adult with a high cholesterol level in your blood, who already has atherosclerotic cardiovascular disease or at high risk of developing a cardiovascular event. It is given:
- together with a statin or other cholesterol lowering medication, if the maximum dose of a statin does not lower levels of cholesterol sufficiently.
- alone or together with other cholesterol lowering medications when statins do not work well or cannot be used.

Repatha is used in patients who cannot control their cholesterol levels with a cholesterol lowering diet alone. You should stay on your cholesterol lowering diet while taking this medicine. In patients who are at high risk of developing a cardiovascular event, Repatha can help prevent heart attack, stroke, and certain heart procedures to restore blood flow to the heart due to a build-up of fatty deposits in your arteries (also known as atherosclerotic cardiovascular disease).

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Repatha if you have liver disease.

In order to improve the traceability of this medicine, your doctor or pharmacist should record the name and the lot number of the product you have been given in your patient file. You may also wish to make a note of these details in case you are asked for this information in the future.

Children and adolescents

The use of Repatha has been studied in children 10 years of age and older being treated for heterozygous or homozygous familial hypercholesterolaemia.

The use of Repatha has not been studied in children under 10 years of age.

Other medicines and Repatha

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Repatha has not been tested in pregnant women. It is not known if Repatha will harm your unborn baby.

It is not known whether Repatha is found in breast milk.

It is important to tell your doctor if you are breast-feeding or plan to do so. Your doctor will then help you decide whether to stop breast-feeding, or whether to stop taking Repatha, considering the benefit of breast-feeding to the baby and the benefit of Repatha to the mother.

Driving and using machines

Repatha has no or negligible influence on the ability to drive and use machines.

Repatha contains sodium

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

Repatha contains proline

This medicine contains 25 mg of proline in each 1.0 mL of 140 mg/mL evolocumab. Proline may be harmful for patients with hyperprolinaemia, a rare genetic disorder in which proline builds up in the body. If you (or your child) have hyperprolinaemia, do not use this medicine unless your doctor has recommended it.

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

The recommended dose depends on the underlying condition:
- for adults with primary hypercholesterolaemia and mixed dyslipidaemia the dose is either 140 mg every two weeks or 420 mg once monthly.
- for children aged 10 years or older with heterozygous familial hypercholesterolaemia the dose is either 140 mg every two weeks or 420 mg once monthly.
- for adults or children aged 10 years or older with homozygous familial hypercholesterolaemia the recommended starting dose is 420 mg once monthly. After 12 weeks your doctor may decide to increase the dose to 420 mg every two weeks. If you also receive apheresis, a procedure similar to dialysis where cholesterol and other fats are removed from the blood, your doctor may decide to start you on a dose of 420 mg every two weeks to coincide with your apheresis treatment.
- for adults with established atherosclerotic cardiovascular disease or at high risk for developing a cardiovascular event, the dose is either 140 mg every two weeks or 420 mg once monthly.

Repatha is given as an injection under the skin (subcutaneous).

If your doctor decides that you or a caregiver can give the injections of Repatha using the automated mini-doser, you or your caregiver should receive training on how to prepare and inject Repatha correctly. Do not try to use the automated mini-doser until you have been shown how to do it by your doctor or nurse. It is recommended that 10 to 13 years old are supervised by an adult when they are using the automated mini-doser.

See the detailed “Instructions for Use” at the end of this leaflet for instructions about how to store, prepare, and use your Repatha automated mini-doser at home.

Before starting Repatha, you should be on a diet to lower your cholesterol. You should keep on this cholesterol lowering diet while taking Repatha.

If your doctor has prescribed Repatha along with another cholesterol lowering medicine, follow your doctor’s instructions on how to take these medicines together. In this case, please read the dosage instructions in the package leaflet of that particular medicine as well.

If you use more Repatha than you should

Contact your doctor or pharmacist immediately.

If you forget to take Repatha

Take Repatha as soon as you can after the missed dose. Then, contact your doctor who will tell you when you should schedule your next dose, and follow the new schedule exactly as your doctor has told you.

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

Common (may affect up to 1 in 10 people)
- Flu (high temperature, sore throat, runny nose, cough and chills)
- Common cold, such as runny nose, sore throat or sinus infections (nasopharyngitis or upper respiratory tract infections)
- Feeling sick (nausea)
- Back pain
- Joint pain (arthralgia)
- Muscle pain
- Injection site reactions, such as bruising, redness, bleeding, pain or swelling
- Allergic reactions including rash
- Headache

Uncommon (may affect up to 1 in 100 people)
- Hives, red itchy bumps on your skin (urticaria)
- Flu-like symptoms

Rare (may affect up to 1 in 1 000 people)
- Swelling of the face, mouth, tongue, or throat (angioedema)

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 label and carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C). Do not freeze.
Store in the original carton in order to protect from light and moisture.

Your medicine (cartridge and automated mini-doser) may be left outside the refrigerator to reach room temperature (up to 25°C) before injection. This will make the injection more comfortable. After removal from the refrigerator, Repatha may be stored at room temperature (up to 25°C) in the original carton and must be used within 1 month.

Do not use this medicine if you notice it is discoloured or contains large lumps, flakes or coloured 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 Repatha contains
- The active substance is evolocumab. Each cartridge contains 420 mg of evolocumab in 3.5 mL of solution (120 mg/mL).
- The other ingredients are proline, glacial acetic acid, polysorbate 80, sodium hydroxide, water for injections.

What Repatha looks like and contents of the pack

Repatha is a solution which is clear to opalescent, colourless to yellowish, and practically free from particles.

Each pack contains one single use cartridge co-packed with a single use automated mini-doser.

Marketing Authorisation Holder and Manufacturer
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands

Marketing Authorisation Holder
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands

Manufacturer
Amgen Technology (Ireland) Unlimited Company
Pottery Road
Dun Laoghaire
Co Dublin
Ireland

Manufacturer
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium

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

België/Belgique/Belgien s.a. Amgen n.v.
Tel/Tél: +32 (0)2 7752711

Lietuva
Amgen Switzerland AG Vilniaus filialas
Tel. +370 5 219 7474

България
Амджен България ЕООД
Тел.: +359 (0)2 424 7440

Luxembourg/Luxemburg s.a. Amgen
Belgique/Belgien
Tel/Tél: +32 (0)2 7752711

Česká republika
Amgen s.r.o.
Tel: +420 221 773 500

Magyarország
Amgen Kft.
Tel.: +36 1 35 44 700

Danmark
Amgen, filial af Amgen AB, Sverige
Tlf.: +45 39617500

Malta
Amgen S.r.l.
Italy
Tel: +39 02 6241121

Deutschland
Amgen GmbH
Tel.: +49 89 1490960

Nederland
Amgen B.V.
Tel: +31 (0)76 5732500

Eesti
Amgen Switzerland AG Vilniaus filialas
Tel: +372 586 09553

Norge
Amgen AB
Tlf: +47 23308000

Ελλάδα
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.
Τηλ: +30 210 3447000

Österreich
Amgen GmbH
Tel: +43 (0)1 50 217

España
Amgen S.A.
Tel: +34 93 600 18 60

Polska
Amgen Biotechnologia Sp. z o.o.
Tel.: +48 22 581 3000

France
Amgen S.A.S.
Tél: +33 (0)9 69 363 363

Portugal
Amgen Biofarmacêutica, Lda.
Tel: +351 21 4220606

Hrvatska
Amgen d.o.o.
Tel: +385 (0)1 562 57 20

România
Amgen România SRL
Tel: +4021 527 3000

Ireland
Amgen Ireland Limited
Tel: +353 1 8527400

Slovenija
AMGEN zdravila d.o.o.
Tel: +386 (0)1 585 1767

Ísland
Vistor
Sími: +354 535 7000

Slovenská republika
Amgen Slovakia s.r.o.
Tel: +421 2 321 114 49

Italia
Amgen S.r.l.
Tel: +39 02 6241121

Suomi/Finland
Amgen AB, sivuliike Suomessa/Amgen AB, filial i Finland
Puh/Tel: +358 (0)9 54900500

Kύπρος
C.A. Papaellinas Ltd
Τηλ: +357 22741 741

Sverige
Amgen AB
Tel: +46 (0)8 6951100

Latvija
Amgen Switzerland AG Rīgas filiāle
Tel: +371 257 25888

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.

Instructions for use:
Repatha single use automated mini-doser and cartridge

Guide to parts
Cartridge

White plunger

Cartridge top
(Do not rotate)
Cartridge bottom
Medicine

Cartridge label

Automated mini-doser
Front view
Skin adhesive
Status light
Start button
(Do not press until ready to inject)

Cartridge door
(do not close without cartridge)

Medicine window
Pull tabs

Back view
Needle cover
Adhesive paper

Battery strip
Left pull tab

Needle inside
(under cover)
Right pull tab
Important: Needle is inside.

Important
Before you use the automated mini-doser and cartridge for use with Repatha, read this important information:
Storing your automated mini-doser and cartridge
- Keep the automated mini-doser and cartridge out of the sight and reach of children.
- Do not store the automated mini-doser and cartridge in extreme heat or cold. For example, avoid storing in your vehicle’s glove box or boot. Do not freeze.
Using your automated mini-doser and cartridge
- Do not shake the automated mini-doser or cartridge.
- Do not remove the automated mini-doser and cartridge from the box or clear tray until you are ready to inject.
- Do not touch the start button until you place the loaded automated mini-doser and cartridge onto your skin and are ready to inject.
- Adult supervision is recommended for children age 13 years and younger while using the automated mini-doser and cartridge.
- You can only press the start button once. If an error occurs, the automated mini-doser cannot be used.
- Do not use the automated mini-doser and cartridge if either have been dropped onto a hard surface. Part of the automated mini-doser and cartridge may be broken even if you cannot see the break. Use a new automated mini-doser and cartridge.
- Do not reuse the automated mini-doser and cartridge. The automated mini-doser and cartridge are for single use only.
- Do not let the automated mini-doser get wet from water or any other liquids. It contains electronics that should not get wet.
- The single use automated mini-doser for subcutaneous injection is intended only for use with the cartridge.
In any above cases, use a new automated mini-doser and cartridge. A healthcare provider familiar with Repatha should be able to answer your questions.

Step 1: Prepare
A
Remove the automated mini-doser and cartridge carton from the refrigerator. Wait 45 minutes.
Important: Wait at least 45 minutes for the automated mini-doser and cartridge to naturally reach room temperature in the carton, before you inject.
- Do not try to warm the cartridge by using a heat source such as hot water or a microwave.
- Do not shake the automated mini-doser and cartridge.
- Do not use if any part of the cartridge appears cracked or broken.
- Do not use if the expiration date printed on the carton label has passed.
In any above cases, use a new automated mini-doser and cartridge.

B
Open the carton and peel away the white paper cover. Remove the automated mini-doser cover from the clear tray.

Clear tray
Cartridge

Automated mini-doser
Plastic cover

Leave the automated mini-doser and cartridge in the clear tray until you are ready to inject.
- Do not touch the start button until the automated mini-doser is on your skin and you are ready to inject.
- Do not use if the white paper cover is missing or damaged.

C
Gather all materials needed for your injection and then wash your hands thoroughly with soap and water.
On a clean, well-lit work surface, place the:
- Clear tray containing the automated mini-doser and cartridge
- Alcohol wipes
- Cotton ball or gauze pad
- Plaster
- Sharps disposal container

D
Choose your automated mini-doser placement. Only use the outer arm if someone else is giving the injection.

You can use:
- Your thigh
- Stomach area (abdomen), except for a 2 inches (5 centimetres) area around your belly button
- Outer area of upper arm (only if someone else is giving the injection)

Upper arm
Stomach area
(abdomen)
Thigh

Clean your injection site with an alcohol wipe. Let your skin dry.
- Do not touch this area again before injecting.
- Do not inject into areas where the skin is tender, bruised, red or hard. Avoid injecting into areas with wrinkles, skin folds, scars, stretch marks, moles and excessive hair.
If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.
Important: To attach the automated mini-doser securely, it is important to use a firm and flat skin surface.

Step 2: Get ready
E
Open the automated mini-doser by swinging the cartridge door to the right. Then, leave the door open.
Do not press the start button until you are ready to inject.

F
Inspect the cartridge.

Cartridge bottom
Medicine
Cartridge label
Cartridge top (do not rotate)
White plunger

Expiration date

Make sure the medicine in the cartridge is clear and colourless to slightly yellow.
- Do not use if the medicine is cloudy or discoloured or contains flakes or particles.
- Do not use if any part of the cartridge appears cracked or broken.
- Do not use if pieces of the cartridge are missing or not securely attached.
- Do not use if the expiration date on the cartridge has passed.
In any above cases, use a new automated mini-doser and cartridge.

G
Clean the cartridge bottom.

Grab here
With one hand, hold the cartridge barrel and clean the cartridge bottom with an alcohol wipe.
- Do not touch the bottom of the cartridge after cleaning with alcohol wipe.
- Do not remove or rotate the cartridge top or bottom.

H
Load the cleaned cartridge into the automated mini-doser and firmly press on the top until it is secured in place.
Load the cartridge straight

Press down firmly

Insert the cartridge bottom first.
- Do not insert the cartridge more than 5 minutes before injection. This can dry out the medicine.
- Do not touch the start button until you have placed the loaded automated mini-doser on your skin.

I
Swing the door to the left. Then, squeeze firmly until it snaps shut.

Squeeze tight

snap

Make sure the cartridge fits securely in the automated mini-doser before you close the door.
• Do not close the door if the cartridge is missing or not fully inserted.
• Do not touch the start button until you have placed the loaded automated mini-doser on your skin.
Important: After you load the automated mini-doser, proceed to the next step without delay.

Step 3: Inject
J
Peel away both green pull tabs to show the adhesive. The automated mini-doser is on when the blue status light flashes.
Right pull tab

Flashing Light

Left pull tab

Skin adhesive

Beep-beep-beep

You must remove both green pull tabs to turn the loaded automated mini-doser on. You will hear beeping and see a flashing blue status light.
• Do not touch the skin adhesive.
• Do not touch the start button until you have placed the loaded automated mini-doser on your skin.
• Do not touch or contaminate the needle cover area.
• Do not place the loaded automated mini-doser on your body if the red status light flashes for more than 5 seconds.
• Do not pull the skin adhesive backing off of the automated mini-doser.
• Do not fold the skin adhesive over onto itself.

K
To securely attach the automated mini-doser, prepare and clean an injection site that is less likely to have body hair, or you can trim the area. Use a firm and flat skin surface.
Stomach area placement

Thigh placement

OR

Stretch method for stomach

Do not stretch for thigh
Important: Adjust your body posture to avoid skin folds and bulges.

L
When the blue light flashes, the automated mini-doser is ready. Keep the stretch (stomach area method only). Hold the loaded automated mini-doser with the blue light visible, and place it on your skin. You may hear beeps.

OR

Flashing Light

beep-beep-beep

The loaded automated mini-doser will lay flat on your body. Make sure the entire adhesive is attached to your skin. Run a finger around the adhesive edges to secure it.
Make sure clothing does not get in the way of the loaded automated mini-doser, and you can see the blue light at all times.
- Do not try to reposition the loaded automated mini-doser after it has been placed onto your skin.

M
Firmly press and release the start button. A flashing green light and a click signals the injection has started.

Flashing Light

beep-beep-beep

• You may hear a pumping sound.
• You may feel a needle pinch.
• Make sure you see a green, flashing status light.
• You may hear beeps indicating your injection has started.

Important: If medication leaks from the loaded automated mini-doser contact your doctor or pharmacist.

N
Injection takes about 5 minutes. The status light turns solid green, and the device beeps, when done.

It is okay to hear a pumping sound start and stop during injection.

• Moderate physical activities can be performed during the injection process, such as walking, reaching and bending.

Flashing Light

5 min

Solid Light

Injection is complete when:
- The status light changes to solid green.
- You hear several beeps.
beep-beep-beep

Step 4: Finish
O
When the injection is done, grab the skin adhesive to carefully peel the automated mini- doser off your skin. After removal, check the medicine window. The green light should now be off.
Used plunger

Light Off

beep-beep-beep

Check to see that the used plunger completely fills the medicine window, and the green solid light turns off, letting you know all medicine has been injected. If the plunger did not fill the window, contact your doctor.
- The used automated mini-doser will beep when removed from your skin.
- It is normal to see a few drops of fluid on your skin after you remove the used automated mini- doser.

P
Discard the used automated mini-doser in a sharps container.
- The automated mini-doser contains batteries, electronics, and a needle.
- Put the used automated mini-doser in sharps disposal container right away after use. Do not throw away (dispose of) the automated mini- doser in your household waste.
- Talk with your healthcare provider about proper disposal. There may be local guidelines for disposal.
- Do not remove the used cartridge from the automated mini-doser.
- Do not reuse the automated mini-doser.
- Do not recycle the automated mini-doser or sharps disposal container or throw them into household waste.

Important: Always keep the sharps disposal container out of the sight and reach of children.

Q
Examine the injection site.
If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site.
Apply a plaster if needed.

Troubleshooting
What to do if the loaded automated mini-doser status light continuously flashes red and you hear beeps.

Flashing Warning Light

beep-beep-beep-beep-beep

Stop using the loaded automated mini-doser. If the automated mini-doser is attached to your body, carefully remove it.

Additional environmental conditions
Relative humidity range is 15% to 85%.
Altitude range is -300 metres to 3 500 metres (-984 feet to 11 483 feet).
During injection, keep the automated mini-doser a minimum of 30 cm (12 inches) away from other electronics such as mobile phones.
Warning: Do not modify the device.
Automated mini-doser operating temperature range is 15°C to 40°C.
www.devicepatents.com

SYMBOL TABLE

Do not use if packaging is damaged
Keep dry
Refer to
Instructions for
Use
Type BF
Applied Part
Single use
Sterilised using ethylene oxide

Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, U.S.A.
Amgen Europe B.V., Minervum 7061, 4817 ZK, Breda, The Netherlands