galcanezumab: package leaflet

For patients

Package leaflet, verbatim

Package leaflet: Emgality 120 mg solution for injection in pre-filled pen

1. What Emgality is and what it is used for

Emgality contains galcanezumab, a medicine that stops the activity of a naturally occurring substance in the body called calcitonin gene-related peptide (CGRP). People with migraine may have increased levels of CGRP.

Emgality is used to prevent migraine in adult patients who have at least 4 migraines days per month.

Emgality can reduce the frequency of migraine headache and improve your quality of life. It starts working in about a week.

2. What you need to know before you use Emgality

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

Warnings and precautions
Talk to your doctor, pharmacist or nurse before or during treatment with Emgality if:
- you have a serious cardiovascular disease. Emgality has not been studied in patients with serious cardiovascular diseases.

Look out for allergic reactions
Emgality can potentially cause serious allergic reactions. Serious allergic reactions happen mainly within 1 day after having taken Emgality, but some reactions can be delayed (happen more than 1 day to 4 weeks after having taken Emgality). Some allergic reactions can be prolonged in duration. You must look out for signs of these reactions while you are using Emgality. Stop using Emgality and tell

your doctor or seek medical help immediately if you notice any signs of a serious allergic reaction.
Such signs are listed under “Serious side effects” in section 4.

Children and adolescents
This medicine should not be given to children and adolescents under 18 years of age because it has not been studied in this age group.

Other medicines and Emgality
Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.

Pregnancy and breast-feeding
If you are a woman able to have children, you are advised to avoid becoming pregnant while using Emgality.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. It is preferable to avoid the use of Emgality in pregnancy as the effects of this medicine in pregnant women are not known.

If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine.
You and your doctor should decide if you should breast feed and use Emgality .

Driving and using machines
Galcanezumab could have a minor effect on your ability to drive and use machines. Some patients have had vertigo whilst using Emgality.

Emgality contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 120 mg dose, that is to say essentially “sodium-free”.

3. How to use Emgality

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

Emgality pre-filled pen is for single use only and contains one dose of Emgality (120 mg).
- The first time you receive Emgality your doctor or nurse will inject two pens (total 240 mg).
- After the first dose, you will use one pen (120 mg) every month.

Your doctor will decide for how long you should use Emgality.

Emgality is given by injection under your skin (subcutaneous injection). You and your doctor or nurse should decide if you can inject Emgality yourself.

It is important not to try to inject yourself until you have been trained by your doctor or nurse. A caregiver may also give you your Emgality injection after proper training.

The pen must not be shaken.

Read the “Instructions for Use” for the pen carefully before using Emgality.

If you use more Emgality than you should
If you have injected more Emgality than you should, e.g. if after the first dose of 240 mg, you have injected it twice in a single month, or if anyone else has accidentally used Emgality, contact your doctor immediately.

If you forget to use Emgality
Do not take a double dose to make up for forgotten injection

If you have forgotten to inject a dose of Emgality, inject the missed dose as soon as possible and then inject the next dose after a month from that date.

If you stop using Emgality
You should not stop using Emgality without speaking to your doctor first.

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

4. Possible side effects

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

Serious side effects

Allergic reactions with Emgality are usually mild to moderate (such as rash or itching). Serious allergic reactions may occur rarely (may affect up to 1 in 1 000 people) and the signs may include:
difficulty breathing or swallowing,
low blood pressure, which can cause dizziness or light-headedness,
swelling of the neck, face, mouth, lips, tongue or throat which may develop rapidly, severe itching of the skin, with a red rash or raised bumps.

Tell your doctor or get emergency medical help straight away if you notice any of those signs.

Other side effects that have been reported.

Very common side effects (may affect more than 1 in 10 people):
- Injection site pain
- Injection site reactions (e.g. red skin, itching, bruising, swelling)

Common side effects (may affect up to 1 in 10 people):
- Vertigo (a feeling of dizziness or “spinning”)
- Constipation
- Itching
- Rash

Uncommon side effects (may affect up to 1 in 100 people):
- Hives (raised itchy areas of skin)

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.

5. How to store Emgality

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 on the carton after “EXP.” The expiry date refers to the last day of that month.

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

Store in the original package in order to protect from light.

Emgality may be stored unrefrigerated for a single period up to 7 days when stored at temperatures up to 30 °C. If the pen is stored at a higher temperature or for a longer period it must be discarded.

Do not use this medicine if you notice that the pen is damaged, or the medicine is cloudy or has particles in it.

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

6. Contents of the pack and other information

What Emgality contains
The active substance is galcanezumab. Each pre-filled pen contains 120 mg of galcanezumab in 1 mL solution.

The other ingredients are: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sodium chloride and water for injections.

What Emgality looks like and contents of the pack
Emgality is a solution for injection in a clear glass syringe. Its colour may vary from colourless to slightly yellow.

The syringe is encased in a disposable, single-dose pen. Pack sizes of 1, 2 or 3 pre-filled pens.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eli Lilly Nederland B. V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands.

Manufacturer:
Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019, Sesto Fiorentino (FI), Italy.
Lilly, S.A., Avda. de la Industria, 30, 28108 Alcobendas, Madrid Spain.

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

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84
Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600

България
ТП "Ели Лили Недерланд" Б.В. - България тел. + 359 2 491 41 40

Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111
Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100

Danmark
Eli Lilly Danmark A/S
Tlf.: +45 45 26 60 00

Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500

Deutschland
Organon Healthcare GmbH
Tel. + 0800 3384 726 (+49 (0) 8920 400 2210) dpoc.germany@organon.com

Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800

Eesti
Eli Lilly Nederland B. V.
Tel: +372 6 817 280

Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00

Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600

Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780

España
Organon Salud, S.L.
Tel: +34 91 591 12 79

Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00
France
Organon France
Tél: +33-(0) 1 57 77 32 00
Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600

Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999
România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000

Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10

Ísland
Icepharma hf.
Sími + 354 540 8000

Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111

Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: +371 67364000

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

Emgality 120 mg solution for injection in pre-filled pen

Galcanezumab

For subcutaneous use

Before using your pre-filled pen (pen):

Important Information

- Your doctor or nurse should show you how to prepare and inject Emgality using the pen.
Do not inject yourself or someone else until you have been shown how to inject Emgality.
- Keep these instructions and refer to them as needed.
- Each pen is for ONE-TIME USE ONLY. Do not share or reuse your pen. Otherwise, you may give or get an infection.
- The pen contains glass parts. Handle it carefully. If you drop it on a hard surface, do not use it. Use a new pen for your injection.
- Your doctor, pharmacist or nurse can help you decide where on your body to inject your dose. You can also read the “Choose your injection site” section of these instructions to help you choose which area can work best for you.
- If you have vision or hearing problems, do not use the pen without help from a caregiver.

INSTRUCTIONS FOR USE

Before you use the EMGALITY pen, read and carefully follow all the step-by-step instructions.

Parts of the Emgality pen

Bottom/ Needle end
Base Cap
Teal
Injection
Button
Lock Ring
Lock/Unlock
Symbols
Medicine
Clear Base
Top

Before You Get Started
Take the pen from the refrigerator
Put the original package with any unused pens back in the refrigerator.
Leave the base cap on until you are ready to inject.
Do not shake.
For a more comfortable injection, leave the pen at room temperature for 30 minutes before injecting.
Do not microwave the pen, run hot water over it, or leave it in direct sunlight.

Inspect the pen and the medicine
Make sure you have the right medicine. The medicine inside should be clear. It may be colourless to slightly yellow.

Do not use the pen, and dispose of as directed by your doctor, pharmacist or nurse if:
• it looks damaged
• the medicine is cloudy, is discolored, or has small particles
• the expiration date printed on the label has passed
• the medicine is frozen

Expiration Date

Uncap the Pen

Make sure the pen is locked. Leave the base cap on until you are ready to inject.
• When you are ready to inject, twist off the base cap and throw it away in the bin.
• Do not put the base cap back on – this could damage the needle.
• Do not touch the needle.

Place and Unlock

• Place and hold the clear base flat and firmly against your skin.

Turn the lock ring to the unlock position.

Prepare for injection
Wash your hands with soap and water before you inject
Emgality. Make sure a sharps disposal container is close by.

Choose your injection site
Your doctor, pharmacist or nurse can help you choose the injection site that is best for you.

• You may inject the medicine into your stomach area (abdomen) or thigh. Do not inject within 5 centimeters of the belly button (navel).
• Another person may give you the injection in the back of your upper arm or buttock.
• Do not inject in the same spot as before. For example, if your first injection was in your abdomen, your next injection could be in another area of your abdomen.
• Clean and dry the injection site before you inject.

Buttock
Thigh
Abdomen
Back of arm

Press and Hold

• Press and hold the teal injection button; you will hear a loud click.

• Keep holding the clear base firmly against your skin. You will hear a second click in about 5 to 10 seconds after the first one. This second click tells you that your injection is complete.

• Remove the pen from your skin.
You will know your injection is complete when you can see the grey plunger.

After You Inject Your Medicine

Dispose of the pen
DO NOT put the base cap back on. Dispose of the pen in a sharps disposal container or as directed by your doctor, pharmacist or nurse.

When you dispose of the pen and the sharps disposal container:
- Do not recycle the filled sharps container.
- Ask your doctor, pharmacist or nurse about how to dispose of medicines you no longer use.

Commonly Asked Questions

Q.
What if I see air bubbles in my pen?
A.
It is normal to have air bubbles in the pen. Emgality is injected under your skin (subcutaneous injection).

Q.
What if there is a drop of liquid on the tip of the needle when I remove the base cap?
A.
It is okay to see a drop of liquid on the tip of the needle.

seconds
Click

Q.
What if I unlocked the pen and pressed the teal injection button before I twisted off the base cap?
A.
Do not remove the base cap. Dispose of the pen and get a new one.

Q.
Do I need to hold the injection button down until the injection is complete?
A.
This is not necessary, but it may help you keep the pen steady and firm against your skin.

Q.
What if the needle did not retract after my injection?
A.
Do not touch the needle or replace the base cap. Store in a safe place to avoid an accidental needlestick. Contact your doctor, pharmacist or nurse for instructions on how to return the pen.

Q.
What if there is a drop of liquid or blood on my skin after my injection?
A.
This is normal. Press a cotton ball or gauze over the injection site. Do not rub the injection site.

Q.
What if I hear more than 2 clicks during my injection – 2 loud clicks and a soft one. Did I get my complete injection?
A.
Some patients may hear a soft click right before the second loud click. That is the normal operation of the pen. Do not remove the pen from your skin until you hear the second loud click.

Q.
How can I tell if my injection is complete?
A.
After you press the teal injection button, you will hear 2 loud clicks. The second click tells you that your injection is complete. You will also see the grey plunger at the top of the clear base.

Read the full Package Leaflet for Emgality inside this box to learn more about your medicine.

Revision date:

Package leaflet: Emgality 120 mg solution for injection in pre-filled syringe