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EMGALITY 120 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN

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About the medicine

How to use EMGALITY 120 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the Patient

Emgality 120mg solution for injection in pre-filled pen

galcanezumab

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 further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Emgality and what is it used for

Emgality contains galcanezumab, a medicine that blocks 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 adults who have at least 4 days of migraine per month.

Emgality may reduce the frequency of migraine and improve your quality of life. It starts working in about one week.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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 severe cardiovascular disease. Emgality has not been studied in patients with severe cardiovascular diseases.

Monitor for allergic reactions

Emgality may potentially cause serious allergic reactions. Serious allergic reactions occur mainly within 1 day after using Emgality, but some reactions may be delayed (occurring more than 1 day and up to 4 weeks after using Emgality). Some allergic reactions can be long-lasting. You should monitor for signs of these reactions while using Emgality. Stop using Emgality and tell your doctor or seek medical attention immediately if you notice any signs of a serious allergic reaction. These signs are listed under “Serious side effects” in section 4.

Children and adolescents

This medicine must not be used in children and adolescents under 18 years 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 breastfeeding

If you are a woman who could become pregnant, you are advised to avoid becoming pregnant while using Emgality.

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. It is preferable to avoid the use of Emgality during pregnancy, as the effects of this medicine in pregnant women are not known.

If you are breastfeeding or plan to breastfeed, consult your doctor before using this medicine. You and your doctor must decide whether to breastfeed or use Emgality.

Driving and using machines

Galcanezumab may have a small effect on the ability to drive and use machines. Some patients have experienced dizziness while using Emgality.

Emgality contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 120 mg dose; this is essentially “sodium-free”.

3. How to use Emgality

Follow the instructions for administration of this medicine exactly as told by your doctor, pharmacist, or nurse. If you are unsure, consult your doctor, pharmacist, or nurse again.

The Emgality pre-filled pen is for single use and contains one dose of Emgality (120 mg).

  • The first time you are given Emgality, your doctor or nurse will inject two pens (240 mg in total).
  • After the first dose, you will use one pen (120 mg) every month.

Your doctor will decide how long you should use Emgality.

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

It is important that you do not try to inject yourself until you have been trained on how to do it by your doctor or nurse. A caregiver can also give you your Emgality injection if they are properly trained.

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 the medicine twice in one month, or if someone else has used Emgality accidentally, contact your doctor immediately.

If you forget to use Emgality

Do not inject a double dose to make up for a 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 one month from that date.

If you stop using Emgality

Do not stop using Emgality without talking to your doctor first.

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

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

Serious side effects

Generally, allergic reactions with Emgality are mild to moderate (such as rash or itching). Serious allergic reactions can occur rarely (may affect up to 1 in 1000 people) and signs may include:

  • difficulty breathing or swallowing,
  • low blood pressure, which can cause dizziness or fainting,
  • swelling of the neck, face, mouth, lips, tongue, or throat which can develop rapidly,
  • severe itching of the skin with rash or hives.

Talk to your doctor or seek medical attention immediately if you notice any of these signs.

Other side effects reported

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

  • Pain at the injection site
  • Injection site reactions (e.g. redness, itching, bruising, swelling)

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

  • Dizziness (a feeling of spinning or dizziness)
  • Constipation
  • Itching
  • Rash

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

  • Hives (rash on the skin with itching)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are 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. Storing 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. The expiry date is the last day of the month shown.

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

Store in the original package to protect from light.

Emgality can be left outside the refrigerator for a single period of up to 7 days at a temperature not above 30°C. The pen should be discarded if stored at a temperature higher or for a longer period.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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 of solution.
  • The other ingredients are: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sodium chloride, and water for injections.

Appearance and pack contents

Emgality is a solution for injection in a clear glass syringe. Its color may vary from colorless to slightly yellow.

The syringe is inserted into a single-use disposable 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., Papendorpseweg 83, 3528 BJ Utrecht, 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.

You can ask for more information about this medicine from the representative of the marketing authorisation holder:

Belgium/België/Belgien

Eli Lilly Benelux S.A./N.V.

Tel: + 32-(0)2 548 84 84

Lithuania

Eli Lilly Lietuva

Tel: +370 (5) 2649600

Text in Bulgarian language with contact information of a pharmaceutical company and phone number

Luxembourg/Luxemburg

Eli Lilly Benelux S.A./N.V.

Tel: + 32-(0)2 548 84 84

Czech Republic

ELI LILLY CR, s.r.o.

Tel: + 420 234 664 111

Hungary

Lilly Hungária Kft.

Tel: + 36 1 328 5100

Denmark

Eli Lilly Danmark A/S

Tel: +45 45 26 60 00

Malta

Charles de Giorgio Ltd.

Tel: + 356 25600 500

Germany

Lilly Deutschland GmbH

Tel: + 49-(0) 6172 273 2222

Netherlands

Eli Lilly Nederland B.V.

Tel: + 31-(0) 30 60 25 800

Estonia

Eli Lilly Nederland B. V.

Tel: +372 6 817 280

Norway

Eli Lilly Norge A.S.

Tel: + 47 22 88 18 00

Greece

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Tel: +30 210 629 4600

Austria

Eli Lilly Ges.m.b.H.

Tel: + 43-(0) 1 711 780

Spain

Organon Salud, S.L.

Tel: +34 91 591 12 79

Poland

Eli Lilly Polska Sp. z o.o.

Tel: +48 22 440 33 00

France

Organon France

Tel: +33-(0) 1 57 77 32 00

Portugal

Lilly Portugal Produtos Farmacêuticos, Lda

Tel: + 351-21-4126600

Croatia

Eli Lilly Hrvatska d.o.o.

Tel: +385 1 2350 999

Romania

Eli Lilly România S.R.L.

Tel: + 40 21 4023000

Ireland

Eli Lilly and Company (Ireland) Limited

Tel: + 353-(0) 1 661 4377

Slovenia

Eli Lilly farmacevtska družba, d.o.o.

Tel: +386 (0)1 580 00 10

Iceland

Icepharma hf.

Tel: + 354 540 8000

Slovakia

Eli Lilly Slovakia s.r.o.

Tel: + 421 220 663 111

Italy

Eli Lilly Italia S.p.A.

Tel: + 39- 055 42571

Finland

Oy Eli Lilly Finland Ab

Tel: + 358-(0) 9 85 45 250

Cyprus

Phadisco Ltd

Tel: +357 22 715000

Sweden

Eli Lilly Sweden AB

Tel: + 46-(0) 8 7378800

Latvia

Eli Lilly (Suisse) S.A Parstavnieciba Latvija

Tel: +371 67364000

United Kingdom(Northern Ireland)

Eli Lilly and Company (Ireland) Limited

Tel: + 353-(0) 1 661 4377

Date of last revision of this leaflet:

Other sources of information

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

Instructions for use

Emgality 120mg solution for injection in pre-filled pen

galcanezumab

For subcutaneous use

White and blue auto-injector device with transparent window showing the plunger and green activation button

Before using your pre-filled pen (pen):

Important Information

  • Your doctor or nurse should teach you how to prepare and inject Emgality using the pen. Do not inject or inject someone else until you have been shown how to inject Emgality.
  • Keep these instructions and re-read them if you need to.
  • Each pen is for SINGLE USE. Do not share or re-use your pen. Otherwise, you may transmit or get an infection.
  • The pen contains glass parts. Handle with care. If it falls on a hard surface, do not use it. Use a new pen for your injection.
  • Your doctor, pharmacist, or nurse can help you decide which area of your body to inject your dose. You can also read the section “Choose your injection site” in these instructions to help you choose which area may be best for you.
  • If you have vision or hearing problems, do notuse the pen without the help of a caregiver.

INSTRUCTIONS FOR USE

Before using the Emgality pen, carefully read and follow all the step-by-step instructions.

Parts of the Emgality pen

Injection device with greenish-blue button, lock ring, medication indicator, transparent base, and lower cap

Pre-filled pen with arrow pointing to circular transparent area where clear liquid without particles is verified

Online doctors for EMGALITY 120 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN

Discuss questions about EMGALITY 120 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

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Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

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Dr. Lokchiri’s professional training includes:

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He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

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Experience and qualifications:

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Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Doctor

Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

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Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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Frequently Asked Questions

Is a prescription required for EMGALITY 120 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN?
EMGALITY 120 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in EMGALITY 120 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN?
The active ingredient in EMGALITY 120 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN is galcanezumab. This information helps identify medicines with the same composition but different brand names.
Who manufactures EMGALITY 120 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN?
EMGALITY 120 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN is manufactured by Eli Lilly Nederland B.V.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of EMGALITY 120 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether EMGALITY 120 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to EMGALITY 120 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN?
Other medicines with the same active substance (galcanezumab) include EMGALITY 120 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, AIMOVIG 140 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN, AIMOVIG 70 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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