Emgality

Package leaflet: Information for the patient

Emgality 120 mg solution for injection in pre-filled pen

galcanezumab
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Emgality is and what it is used for
2. What you need to know before using Emgality
3. How to use Emgality
4. Possible side effects
5. How to store Emgality
6. Contents of the pack and other information

1. What Emgality is and what it is used for

Emgality contains galcanezumab, a medicine that neutralizes 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 migraine days per month.
Emgality can reduce the frequency of migraine and improve quality of life. Its effect begins within about one week.

2. What you need to know before using Emgality

Do not use Emgality

• if you are allergic to galcanezumab or to 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 severe cardiovascular disease. Emgality has not been studied in patients with severe cardiovascular diseases.

Be aware of allergic reactions
Emgality may theoretically cause serious allergic reactions. Serious allergic reactions mainly occur within 1 day after taking Emgality, but some reactions may be delayed (appearing from more than 1 day up to 4 weeks after taking Emgality). Some allergic reactions may last for a prolonged period. You should pay attention to signs of these reactions while using Emgality. Stop using Emgality and inform your doctor or seek immediate medical help if you notice any sign of a serious allergic reaction. These signs are listed in section 4 under "Serious unwanted effects".

Children and adolescents
This medicine must not be given to children and adolescents under 18 years of age, as 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 breastfeeding
If you are a woman of childbearing age, it is recommended to avoid becoming pregnant during treatment with Emgality.
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine. It is preferable to avoid using Emgality during pregnancy, as the effects of this medicine in pregnant women are unknown.
If you are breastfeeding or planning to breastfeed, talk to your doctor before using this medicine. You and your doctor will need to decide whether you should breastfeed and use Emgality.

Driving and using machines
Galcanezumab may have a minor influence on the ability to drive or use machines. Some patients have experienced dizziness during treatment with Emgality.

Emgality contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 120 mg dose, i.e. essentially "sodium-free".

3. How to use Emgality

Use this medicine exactly as instructed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
The Emgality pre-filled pen is for single use only and contains one dose of Emgality (120 mg).

• The first time Emgality is administered to you, your doctor or nurse will inject the contents of two pens (for a total of 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 administered by subcutaneous injection (injection under the skin). You and your doctor or nurse will decide whether you can self-inject Emgality.
It is important that you do not attempt to inject the medicine yourself until you have received proper instructions from your doctor or a nurse. A caregiver may also inject Emgality for you after receiving proper instructions.
Do not shake the pen.
Carefully read the “Instructions for Use” for the pen before using Emgality.

If you use more Emgality than you should
If you have injected more Emgality than you should, for example, if after the initial 240 mg dose you administered two doses within a single month, or if someone else accidentally used Emgality, inform your doctor immediately.

If you forget to use Emgality
Do not take a double dose to make up for a forgotten injection.
If you forget to inject a dose of Emgality, take the missed dose as soon as possible, then administer the next dose one month after that date.

If you stop using Emgality
You should not stop treatment with Emgality without first talking to your doctor.
If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

Serious side effects

Allergic reactions with Emgality are usually mild to moderate (such as rash or itching). Serious allergic reactions may rarely occur (may affect up to 1 in 1,000 people), and signs may include:

• difficulty breathing or swallowing,
• low blood pressure, which may cause dizziness or a feeling of lightheadedness,
• swelling of the neck, face, mouth, lips, tongue or throat that may develop rapidly,
• severe itching of the skin, with red rash or raised bumps.

Contact your doctor immediately or seek emergency medical help if you notice any of these signs.

Other side effects that have been reported

Very common side effects (may affect more than 1 in 10 people):

• pain at the injection site
• reactions at the injection site (for example, redness, itching, bruising, swelling)

Common side effects (may affect up to 1 in 10 people):

• dizziness (a sensation of spinning or feeling lightheaded)
• constipation
• itching
• rash

Uncommon side effects (may affect up to 1 in 100 people):

• hives (itchy, raised areas on the skin)

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex 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 carton after
“EXP”/“Scad.”. The expiry date refers to the last day of that month.
Store in a refrigerator (from 2 °C to 8 °C). Do not freeze.
Keep in the original packaging to protect the medicine from light.
Emgality may be stored unrefrigerated for a single period not exceeding 7 days at temperatures up to 30 ºC. If the pen is stored at higher temperatures or for a longer period of time, it must be discarded.
Do not use this medicine if you notice that the pen is damaged, or if the solution appears cloudy or contains particles.
Do not dispose of any medicine via wastewater or household waste. Ask your doctor, nurse, or pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Emgality contains
The active substance is galcanezumab. Each pre-filled pen contains 120 mg of galcanezumab in 1 mL of solution.
The other components are: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sodium chloride, water for injectable preparations.

Description of the appearance of Emgality and contents of the pack
Emgality is an injectable solution in a clear glass syringe. The colour may vary from colourless to slightly yellow.
The syringe is placed inside a single-use, single-dose pen. Packs containing 1, 2 or 3 pre-filled pens.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

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

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

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

България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A./N.V.
тел. + 359 2 491 41 40 Tél/Tel: + 32-(0)2 548 84 84

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

Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf: +45 45 26 60 00 Tel: + 356 25600 500

Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800

Eesti Norge
Eli Lilly Nederland B. V. Eli Lilly Norge A.S.
Tel: +372 6 817 280 Tlf: + 47 22 88 18 00

Ελλάδα Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Eli Lilly Ges.m.b.H.
Τηλ: +30 210 629 4600 Tel: + 43-(0) 1 711 780

España Polska
Lilly S.A. Eli Lilly Polska Sp. z o.o.
Tel: + 34-91 663 50 00 Tel: +48 22 440 33 00

France Portugal
Lilly France Lilly Portugal Produtos Farmacêuticos, Lda
Tél: +33-(0) 1 55 49 34 34 Tel: + 351-21-4126600

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

Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353-(0) 1 661 4377 Tel: +386 (0)1 580 00 10

Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia s.r.o.
Sími + 354 540 8000 Tel: + 421 220 663 111

Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39- 055 42571 Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Τηλ: +357 22 715000 Tel: + 46-(0) 8 7378800

Latvija United Kingdom (Northern Ireland)
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Eli Lilly and Company (Ireland) Limited
Tel: +371 67364000 Tel: + 353-(0) 1 661 4377

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu

Instructions for use

Emgality 120 mg solution for injection in pre-filled pen

Galcanezumab
For subcutaneous use

Before using the pre-filled pen (pen):
Important information

• Your doctor or nurse must show you how to prepare and inject Emgality using the pen. Do not inject yourself or another person until you have been shown how to administer Emgality.
• Keep these instructions for use and consult them whenever needed.
• Each pen is FOR SINGLE USE ONLY. Do not share or reuse the pen. Otherwise, you may transmit or acquire an infection.
• The pen contains glass parts. Handle it carefully. If it falls on a hard surface, do not use it. Use a new pen for injection.
• Your doctor, pharmacist, or nurse can help you decide where on the body to give the injection. You may also read the section "Choose the injection site" in these instructions to help you select the most suitable area.
• If you have vision or hearing problems, do not use the pen without the help of an assisting person.

INSTRUCTIONS FOR USE
Before using the EMGALITY pen, read and carefully follow all instructions step by step.
Parts of the Emgality pen
Upper part

Turquoise
injection
button
Lock ring
Lock/unlock
symbols
Medicine
Transparent base
Base cap
Lower part / Needle end
Preparation
Take the pen from the Return unused pens with the original packaging to the
refrigerator refrigerator.
Leave the base cap on until you are ready to inject.
Do not shake the pen.
For a more comfortable injection, allow the pen to reach room
temperature for 30 minutes before use.
Do not place the pen in a microwave or under hot water, and
do not leave it in direct sunlight.
Inspect the pen and the Make sure you have the correct medicine. The liquid inside
medicine should be clear. It may be colorless to slightly yellow.
Do not use the pen and dispose of it as instructed by your doctor,
pharmacist, or nurse if:

• it appears damaged
• the medicine is cloudy, discolored, or contains small particles
• the expiry date printed on the label has passed
• the medicine has been frozen

Expiry date

Prepare for injection Wash your hands with soap and water before injecting
Emgality. Make sure you have a sharps container nearby.
Choose the injection site Your doctor, pharmacist, or nurse can help you choose
the best injection site for you.

• You may inject the medicine in the stomach (abdomen) or
  thigh area. Do not inject within 5 centimeters around the
  navel.

• Another person may inject it into the back of your upper arm
  or buttock.

• Do not inject in the same spot as your previous injection. For example, if your first injection was in the abdomen, the next injection could be in a different area of the abdomen.

• Clean and dry the injection site before injecting.

1 Unscrew the pen cap

Make sure the pen is in the locked position. Leave the base cap on until you are ready to inject.

• When ready to inject, unscrew the base cap and dispose of it in a waste container.
• Do not replace the base cap – doing so may damage the needle.
• Do not touch the needle.

2 Position and Unlock

• Place and hold the transparent base firmly and evenly against the skin. Turn the lock ring to the

unlocked position.
3 Press and Hold

• Press and hold the turquoise injection button; Click you will hear a loud click.
• Hold the transparent base firmly against the skin. You will hear a second click 5 to 10 seconds after the first. This second click indicates that the injection is complete.

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

After completing the injection
Dispose of the pen
DO NOT replace the base cap. Dispose of the

pen in a sharps container or as instructed by your doctor,
pharmacist, or nurse.
When disposing of the pen and sharps container:

• Do not recycle the sharps container.
• Ask your doctor, pharmacist, or nurse how to dispose of unused medicines.

Frequently asked questions
Q. What if I see air bubbles in the pen?
A. It is normal to have air bubbles in the pen. Emgality is injected subcutaneously (subcutaneous injection).
Q. What if there is a drop of liquid on the needle tip when I remove the base cap?
A. It is normal to see a drop of liquid on the needle tip.
Q. What if I unlocked the pre-filled pen and pressed the turquoise injection button before unscrewing the base cap?
A. Do not remove the base cap. Discard the pen and take a new one.
Q. Do I need to keep pressing the injection button until the injection is complete?
A. This is not necessary, but it may help keep the pen stable and firmly against the skin.
Q. What if the needle does not retract after injection?
A. Do not touch the needle or replace the base cap. Keep the pen in a safe place to avoid accidental needlestick injury. Contact your doctor, pharmacist, or nurse for instructions on returning the pen.
Q. What if there is a drop of liquid or blood at the injection site after injection?
A. This is normal. Press a cotton ball or gauze pad on the injection site. Do not rub the injection site.
Q. What if I heard more than 2 clicks during injection – 2 loud clicks and one soft click. Did I receive the full dose?
A. Some patients may hear a soft click just before the second loud click. This is normal. Do not remove the pre-filled pen from the skin until you hear the second loud click.
Q. How do I know if the injection is complete?
A. After pressing the turquoise injection button, you will hear 2 loud clicks. The second click signals that the injection is complete. You will also see the gray plunger in the upper part of the transparent base.
Read the Emgality Package Leaflet inside this package for more information about the medicine.
Revision date:

Patient information leaflet

Emgality 120 mg solution for injection in pre-filled syringe

galcanezumab
Please read this entire leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Emgality is and what it is used for
2. What you need to know before using Emgality
3. How to use Emgality
4. Possible side effects
5. How to store Emgality
6. Contents of the pack and other information

1. What Emgality is and what it is used for

Emgality contains galcanezumab, a medicine that neutralizes 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 migraine days per month.
Emgality can reduce the frequency of migraine and improve quality of life. Its effect begins within about one week.

2. What you need to know before using Emgality

Do not use Emgality

• if you are allergic to galcanezumab or to 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 severe cardiovascular disease. Emgality has not been studied in patients with severe cardiovascular disease.

Be aware of allergic reactions
Emgality may theoretically cause serious allergic reactions. Serious allergic reactions occur
mainly within 1 day after taking Emgality, but some reactions may be delayed
(appearing from more than 1 day up to 4 weeks after taking Emgality). Some allergic
reactions may be prolonged in duration. You should be alert to the signs of these reactions
while using Emgality. Stop using Emgality and inform your doctor or seek immediate
medical help if you notice any sign indicating a serious allergic reaction. These signs are
listed in section 4 under "Serious unwanted effects".

Children and adolescents
This medicine must 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 taking, have recently taken, or might take
any other medicines.

Pregnancy and breastfeeding
If you are a woman of childbearing age, it is recommended to avoid becoming pregnant during treatment with
Emgality.
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, ask your doctor for advice
before taking this medicine. It is preferable to avoid using Emgality during pregnancy,
as the effects of this medicine in pregnant women are unknown.
If you are breastfeeding or planning to breastfeed, talk to your doctor before using
this medicine. You and your doctor will need to decide whether you should breastfeed and use Emgality.

Driving and using machines
Galcanezumab may have a minor influence on the ability to drive or use machines. Some patients
have experienced dizziness during treatment with Emgality.

Emgality contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 120 mg dose, i.e.
essentially "sodium-free".

3. How to use Emgality

Use this medicine exactly as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
The Emgality pre-filled syringe is for single use only and contains one dose of Emgality (120 mg).

• The first time Emgality is administered to you, your doctor or nurse will inject the contents of two syringes (for a total of 240 mg).
• After the first dose, you will use one syringe (120 mg) every month.

Your doctor will decide for how long you should use Emgality.
Emgality is administered by subcutaneous injection (an injection under the skin). You and your doctor or nurse will decide whether you can self-inject Emgality.
It is important that you do not try to inject the medicine yourself until you have received proper instructions from your doctor or a nurse. A caregiver may also inject Emgality after receiving appropriate instructions.
Do not shake the syringe.
Read the “Instructions for Use” for the syringe carefully before using Emgality.

If you use more Emgality than you should
If you have injected more Emgality than prescribed, for example, if you administered two doses within a single month following the initial 240 mg dose, or if someone else accidentally used Emgality, inform your doctor immediately.

If you forget to use Emgality
Do not take a double dose to make up for a missed injection.
If you forget to inject a dose of Emgality, take the missed dose as soon as possible, then administer the next dose one month after that date.

If you stop using Emgality
You should not stop treatment with Emgality without first discussing it with your doctor.
If you have any questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
Allergic reactions with Emgality are usually mild to moderate (such as rash or itching). Serious allergic reactions may rarely occur (may affect up to 1 in 1,000 people), and signs may include:

• difficulty breathing or swallowing,
• low blood pressure, which may cause dizziness or a feeling of lightheadedness,
• swelling of the neck, face, mouth, lips, tongue or throat that may develop rapidly,
• severe itching of the skin, with red rash or raised bumps.

Contact your doctor immediately or seek emergency medical help if you notice any of these 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 (for example, redness, itching, bruising, swelling)

Common side effects (may affect up to 1 in 10 people):

• dizziness (a sensation of spinning or lightheadedness)
• constipation
• itching
• rash

Uncommon side effects (may affect up to 1 in 100 people):

• urticaria (itchy, raised areas on the skin)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system indicated 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 the carton after
"EXP"/"Scad.". The expiry date refers to the last day of that month.
Store in the refrigerator (from 2 °C to 8 °C). Do not freeze.
Keep in the original packaging to protect the medicine from light.
Emgality may be stored unrefrigerated for a single period not exceeding 7 days at temperatures up to 30 ºC. If the syringe is stored at higher temperatures or for a longer period of time, it must be discarded.
Do not use this medicine if you notice that the syringe is damaged, or if the solution appears cloudy or contains particles.
Do not dispose of any medicine via wastewater or household waste. Ask your doctor, nurse, or pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Emgality contains
The active substance is galcanezumab. Each pre-filled syringe contains 120 mg of galcanezumab in
1 mL of solution.
The other components are: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sodium chloride, water for injections.
Description of the appearance of Emgality and contents of the pack
Emgality is an injectable solution in a single-dose transparent glass syringe. The colour may
range from colourless to slightly yellow. Packs containing 1, 2 or 3 pre-filled syringes.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and manufacturer
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Manufacturer
Eli Lilly Italia S.p.A., Via A. Gramsci 731/733, 50019, Sesto Fiorentino (FI), Italy.
For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
Belgique/België/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32-(0)2 548 84 84 Tel. +370 (5) 2649600
България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A./N.V.
тел. + 359 2 491 41 40 Tél/Tel: + 32-(0)2 548 84 84
Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100
Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf: +45 45 26 60 00 Tel: + 356 25600 500
Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800
Eesti Norge
Eli Lilly Nederland B. V. Eli Lilly Norge A.S.
Tel: +372 6 817 280 Tlf: + 47 22 88 18 00
Ελλάδα Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Eli Lilly Ges.m.b.H.
Τηλ: +30 210 629 4600 Tel: + 43-(0) 1 711 780
España Polska
Lilly S.A. Eli Lilly Polska Sp. z o.o.
Tel: + 34-91 663 50 00 Tel: +48 22 440 33 00
France Portugal
Lilly France Lilly Portugal Produtos Farmacêuticos, Lda
Tél: +33-(0) 1 55 49 34 34 Tel: + 351-21-4126600
Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000
Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353-(0) 1 661 4377 Tel: +386 (0)1 580 00 10
Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia s.r.o.
Sími + 354 540 8000 Tel: + 421 220 663 111
Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39- 055 42571 Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Τηλ: +357 22 715000 Tel: + 46-(0) 8 7378800
Latvija United Kingdom (Northern Ireland)
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Eli Lilly and Company (Ireland) Limited
Tel: +371 67364000 Tel: + 353-(0) 1 661 4377
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu

Instructions for use

Emgality 120 mg solution for injection in pre-filled syringe

Galcanezumab
For subcutaneous use

Before using the pre-filled syringe:
Important information

• Your doctor or nurse must show you how to prepare and inject Emgality using the syringe. Do not inject yourself or another person until you have been shown how to administer Emgality.
• Keep these instructions for use and refer to them whenever needed.
• Each syringe is FOR SINGLE USE ONLY. Do not share or reuse the syringe. Otherwise, you may transmit or receive an infection.
• Your doctor, pharmacist, and nurse can help you decide where on your body to give the injection. You may also read the section “Choose the injection site” in these instructions to help you select the most suitable area.
• If you have vision or hearing problems, do not use the syringe without the help of an assisting person.

INSTRUCTIONS FOR USE

Before using the EMGALITY syringe, read and carefully follow all instructions step by step.
Parts of the Emgality syringe

Thumb button
Turquoise plunger rod
Grip
Gray plunger
of the syringe
Syringe barrel
with medicine
Needle
Needle cap

Preparation

Take the syringe out of the refrigerator
Return the original packaging with any unused syringes to the refrigerator.
Leave the needle cap on until you are ready to administer the injection.
Do not shake the syringe.
For a more comfortable injection, allow the syringe to reach room temperature for 30 minutes before use.
Do not place the syringe in a microwave or under hot water, and do not leave it in direct sunlight.

Inspect the syringe and medicine
Make sure you have the correct medicine. The solution inside should be clear. It may be colourless to slightly yellow.
Do not use the syringe and dispose of it as instructed by your doctor, pharmacist, or nurse if:

• it appears damaged
• the medicine is cloudy, discoloured, or contains small particles
• the expiry date printed on the label has passed
• the medicine has been frozen

Expiry date

Prepare for injection
Wash your hands with soap and water before administering the Emgality injection. Make sure you have a sharps container nearby.
Choose the injection site
Your doctor, pharmacist, and nurse can help you choose the most suitable injection site.

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

administering the injection.

1 Remove the cap

• Leave the needle cap on until you are ready to administer the injection.
• When ready, remove the needle cap and dispose of it in a waste container.
• Do not replace the cap at the base — doing so may damage the needle or cause accidental injury.
• Do not touch the needle.

2 Insertion

• Gently pinch and hold the skin at the injection site.
• Insert the needle at a 45° angle.

3 Inject

• Slowly press the thumb button to push the plunger all the way down until all the medicine has been injected.
• The gray plunger of the syringe must be fully depressed to the end of the syringe.
• When the injection is complete,

you should see the turquoise
plunger rod through the
barrel of the syringe, as
shown.
Turquoise plunger rod

• Gently remove the needle from the skin. Gray plunger of the syringe
• Do not replace the needle cap on the syringe.

After administering the injection
Dispose of the syringe
DO NOT replace the needle cap. Dispose of

the syringe in a sharps container or as instructed by your doctor, pharmacist, or nurse.
When disposing of the syringe and sharps container:

• Do not recycle the sharps container.
• Ask your doctor, pharmacist, or nurse how to dispose of medicines you no longer use.

Frequently asked questions
Q. What should I do if I see air bubbles in the Emgality syringe?
A. It is normal to have air bubbles in the syringe. Emgality is administered subcutaneously (subcutaneous injection).
Q. What should I do if there is a drop of liquid on the needle tip when I remove the needle cap?
A. It is normal to see a drop of liquid on the needle tip.
Q. What should I do if I cannot press the plunger?
A. If the plunger is blocked or damaged:

• Do not continue using the syringe
• Remove the needle from the skin
• Dispose of the syringe and use a new one.

Q. What should I do if there is a drop of liquid or blood on the skin after the injection?
A. This is normal. Press a cotton ball or gauze pad against the injection site. Do not rub the injection site.
Q. How do I know when the injection is complete?
A. When the injection is complete:

• The turquoise plunger rod must be visible through the syringe barrel.
• The gray plunger of the syringe must be fully depressed to the end of the syringe.

Read the Emgality Package Leaflet inside this package for more information about the medicine.
Date of revision: