120 mg injection, solution in a prefilled pen 
galkanezumab

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to 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).

In this leaflet you will find information about: 
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 packaging and other information 

1. What Emgality is and what it is used for

Emgality contains galkanezumab, a drug that prevents the activity of a naturally occurring substance in the body called a calcitonin-related peptide (CGRP). People with migraines may have elevated levels of CGRP.

Emgality is used to prevent migraines in adult patients who have at least 4 migraine days per month.

Emgality can reduce your migraine attacks and improve your quality of life. It starts to work after about a week.

2. What you need to know before using Emgality

Do not use Emgality

If you are allergic to galkanezumab or any of the other ingredients of this medicine (see label).

Warnings and cautions

If you have a serious cardiovascular disease, talk to your doctor, pharmacist, or nurse before using Emgality. Emgality has not been studied in patients with severe cardiovascular disease.

Be aware of allergic reactions

There is a risk that Emgality causes allergic reactions. You must be aware of signs of such reactions while using Emgality. Stop taking Emgality and contact a doctor or see the nearest emergency department immediately if there are signs of a severe allergic reaction.

Children and young people

This medicine is not recommended for children and adolescents under 18 years of age as it has not been studied in this age group.

Other drugs and Emgality

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding, and fertility

If you are a woman and can have children, you are advised to avoid becoming pregnant while being treated with Emgality.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. You should not use Emgality during pregnancy as the effects of this medicine on pregnant women are not known.

If you are breast-feeding or planning to breast-feed, talk to your doctor before using this medicine. You and your doctor should decide if you can breast-feed and use Emgality.

Driving and using machines

Galkanezumab may have a minor effect on your ability to drive or use machines. Some patients have experienced dizziness while using Emgality.

Emgality contains excipients

This medicine contains less than 1 mmol sodium (23 mg) per 120 mg dose, ie essentially ‘sodium-free’. is almost “sodium-free”.

3. How to use Emgality

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

Emgality prefilled injection pen is intended for single-use and contains a dose Emgality (120 mg).

  • The first time you receive Emgality, your doctor or nurse will inject the contents of 2 pre-filled pens (240 mg in total).
  • After the first dose, use 1 pre-filled pen (120 mg) a month.

Your doctor will decide how long you should use Emgality.

Emgality is given as an injection under the skin ( subcutaneous injection ). You and your doctor or nurse should decide if you can give yourself the injections with Emgality.

You mustn’t try to give the injections yourself until the doctor or nurse has shown you how to do it. A caregiver can also give you an Emgality injection after you have received training.

The pen must not be shaken.

Carefully read the instructions for use of the pen before using Emgality.

If you use more Emgality than you should  

If you have injected too much Emgality, e.g. If you have injected two doses of 240 mg after the first dose during the same month, or if someone else has accidentally used Emgality, contact 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 one dose of Emgality, inject the missed dose as soon as possible and then continue with the next dose one month after that date.

If you stop using Emgality

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

If you have any further questions on the use of this product, 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 are 

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

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

Tell your doctor or seek emergency care if you get any of these signs.

Other side effects that have been reported:

A very common side effect is (can occur in more than 1 in 10):

  • injection site pain
  • injection site reactions (eg skin redness, itching, bruising, swelling).

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

  • dizziness or tingling sensation
  • constipation
  • itching
  • rash.

Less common side effects are (may affect up to 1 in 100):

  • hives (increase itchy rash on the skin).

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly via the national reporting system to:

The Medical Products Agency

Box 26

SE-751 03 Uppsala


By reporting side effects, you can help increase drug safety information.

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”. The expiration date is the last day of the specified month.

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

Store in the original package. Sensitive to light.

Emgality can be stored outside the refrigerator for a single period of no more than 7 days when stored at temperatures not exceeding 30 ° C. If the pre-filled pen is stored at a higher temperature or for a longer period of time, it must be discarded.

Do not use this medicine if the pen is damaged or if the medicine is cloudy or contains particles. Medicines should not be disposed of via wastewater or household waste.

Ask your doctor, nurse, or pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is galkanezumab. One pre-filled pen contains 120 mg galkanezumab in 1 ml solution.

The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sodium chloride, and water for injections.

What the medicine looks like and the contents of the pack

Emgality is a solution for injection in a clear glass syringe. The color can vary from colorless to pale yellow. The syringe is enclosed in a single-use disposable pen. Available in packs of 1, 2, or 3 pre-filled pens.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

Manufacturer

Eli Lilly Italia SpA, Via Gramsci 731/733, 50019, Sesto Fiorentino (FI), Italy.

Muhammad Nadeem

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