Emgality 120 mg solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Emgality 120 mg solution for injection in a 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, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, talk to your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the 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 blocks the activity of a substance naturally produced 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 migraine days per month.

Emgality can reduce the frequency of migraine and improve quality of life. It begins to work within approximately 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 a serious cardiovascular disease. Emgality has not been studied in patients with serious cardiovascular diseases.

Watch for allergic reactions

Emgality may potentially cause serious allergic reactions. Serious allergic reactions mainly occur 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 may be prolonged in duration. You should monitor for signs of these reactions while using Emgality. Stop using Emgality and contact your doctor or seek immediate medical attention if you notice any signs of a serious allergic reaction. These signs are listed under “Serious adverse reactions” in section 4.

Children and adolescents

This medicine should 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 taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are a woman of childbearing potential, 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 using Emgality during pregnancy, as the effects of this medicine in pregnant women are unknown.

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

Driving and using machines

Galcanezumab may have a minor influence 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; hence, it is essentially “sodium-free”.

3. How to use Emgality

Follow exactly the instructions for administration of this medicine given by your doctor, pharmacist, or nurse. If in doubt, 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 receive 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 for how long you should use Emgality.

Emgality is administered by injection under the skin (subcutaneous injection). You and your doctor or nurse should decide whether you can self-inject Emgality.

It is important that you do not attempt to inject yourself until you have been trained how to do so by your doctor or nurse. A caregiver may also administer your Emgality injection, provided they have been properly trained.

The pen must not be shaken.

Read carefully the “Instructions for Use” of 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 injected the medicine twice within one month, or if someone else has accidentally used Emgality, contact your doctor immediately.

If you forget to use Emgality

Do not inject a double dose to make up for the missed injection.

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

If you stop using Emgality

You must not stop using Emgality without first talking to your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone gets them.

Serious adverse effects

In general, allergic reactions with Emgality are mild to moderate (such as rash or itching). Rarely, serious allergic reactions may 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 mild lightheadedness,
• swelling of the neck, face, mouth, lips, tongue or throat that may progress rapidly,
• intense itching of the skin accompanied by rash or hives.

Contact your doctor or seek immediate medical attention if you notice any of these signs.

Other reported adverse effects

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

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

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

• Dizziness (a sensation of lightheadedness or spinning)
• Constipation
• Itching
• Skin rash

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

• Urticaria (hives with itching)

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Emgality

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

Do not use this medicine after the expiry date stated on the label and the carton after EXP. The expiry date refers to the last day of the month indicated.

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

Keep in the original packaging to protect from light.

Emgality may be kept outside the refrigerator for a single period of up to 7 days at a temperature not exceeding 30 °C. The pen must be discarded if stored at higher temperatures or for longer periods.

Do not use this medicine if you notice that the pen is damaged, or if the medicine appears cloudy or contains particles.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Emgality

• 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 hydrochloride monohydrate, polysorbate 80, sodium chloride, and water for injections.

Appearance of the product and contents of the pack

Emgality is an injectable solution in a clear glass syringe. Its colour may vary from colourless to slightly yellow.

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

Only certain pack sizes may be marketed.

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

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.euopa.eu/.

Parts of the Emgality pen