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

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.

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:

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/.

Parts of the Emgality pen