Emgality 120 mg solution for injection

XPIL (Text-only Patient Information Leaflet)

Source: Emgality_PIL_EM038_Jul24_IE-MT.pdf

Note: This XPIL text version is intended for accessibility (screen readers / large print).

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Package leaflet: Information for the patient

Emgality® 120 mg 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.

What is in this leaflet

1. What Emgality is and what it is used for

2. What you need to know before you use Emgality

3. How to use Emgality

4. Possible side effects

5. How to store Emgality

6. Contents of the pack and other information

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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 migraine days per month.

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

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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 (more than 1 day to 4 weeks after). Some allergic reactions can be prolonged in duration.

Stop using Emgality and tell your doctor or seek medical help immediately if you notice any signs of a serious allergic reaction (see “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

- Women able to have children 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 use in pregnancy as the effects are not known.

- If you are breast-feeding or planning to breast-feed, talk to your doctor. You and your doctor should decide whether to breast-feed while using Emgality.

Driving and using machines

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

Emgality contains sodium

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

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3. How to use Emgality

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

- Emgality pre-filled pen is for single use only and contains one dose of 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 how long you should use Emgality.

Administration

- Emgality is given by injection under the skin (subcutaneous injection).

- You and your doctor or nurse should decide if you can inject it yourself.

- Do not try to inject yourself until you have been trained. A caregiver may also give the injection after training.

- Do not shake the pen.

- Read the “Instructions for Use” carefully before injecting.

If you use more Emgality than you should

If you inject more than prescribed (e.g., two 240 mg doses in one month) or if someone else uses it accidentally, contact your doctor immediately.

If you forget to use Emgality

- Do not take a double dose.

- Inject the missed dose as soon as possible, then inject the next dose one month later.

If you stop using Emgality

Do not stop without speaking to your doctor first.

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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 (rash or itching). Rarely, serious allergic reactions may occur (up to 1 in 1,000 people). Signs may include:

- difficulty breathing or swallowing

- low blood pressure (causing dizziness or light-headedness)

- swelling of the neck, face, mouth, lips, tongue or throat

- severe itching with red rash or raised bumps

Seek emergency help straight away if you notice any of these signs.

Other side effects

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

 - Injection site pain

 - Injection site reactions (redness, itching, bruising, swelling)

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

 - Vertigo (feeling of dizziness or “spinning”)

 - Constipation

 - Itching

 - Rash

- Uncommon (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. You can also report directly via:

- Ireland: HPRA Pharmacovigilance (www.hpra.ie)

- Malta: ADR Reporting (www.medicinesauthority.gov.mt/adrportal)

By reporting side effects, you help provide more information on the safety of this medicine.

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5. How to store Emgality

- Keep out of the sight and reach of children.

- Do not use after the expiry date (EXP).

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

- Keep in the original package to protect from light.

- May be stored unrefrigerated for a single period up to 7 days at ≤30 °C. Discard if stored longer or at higher temperatures.

- Do not use if the pen is damaged, cloudy, or contains particles.

- Do not dispose of via wastewater or household waste. Ask your pharmacist how to dispose of medicines.

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6. Contents of the pack and other information

What Emgality contains

- The active substance is galcanezumab. Each pen contains 120 mg in 1 mL solution.

- Other ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sodium chloride, water for injections.

What Emgality looks like

- Clear glass syringe in a disposable, single-dose pen.

- Solution colour: colourless to slightly yellow.

- Pack sizes: 1, 2 or 3 pens (not all pack sizes may be marketed).

Marketing Authorisation Holder

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht

The Netherlands

Manufacturer

Lilly, S.A.

Avda. de la Industria, 30, 28108 Alcobendas, Madrid

Spain

Local contacts

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

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

This leaflet was last revised in July 2024.

Other sources of information

Detailed information is available at: www.ema.europa.eu

Code: EM038