Emgality 120 mg injection, solution in a prefilled pen galkanezumab
1. What Emgality Is And What It Is Used For
This medicine 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.
This is used to prevent migraine in adult patients who have at least 4 migraine days per month.
This medicine 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 it. This medicine has not been studied in patients with severe cardiovascular disease.
Be aware of allergic reactions to emgality
There is a risk that can cause emgality allergic reaction. You must be aware of signs of such reactions while using it. Stop taking doses and contact a doctor or see the nearest emergency department immediately if there are signs of a severe allergic reaction to emgality.
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 this medicine.
If you are pregnant or breastfeeding, 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 it during pregnancy as the effects of this medicine on pregnant women are not known.
If you are breastfeeding or planning to breastfeed, talk to your doctor before using this medicine. You and your doctor should decide if you can breastfeed and use this medicine.
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 it.
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 of Emgality (120 mg).
- The first time you get this injection, 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 it.
- This medicine 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 it.
If You Use More Emgality Than You Should
If you have injected too much medicine, 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 this medicine, 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 about the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible Emgality Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects of emgality are
Allergic reaction to emgality is usually mild to moderate (such as rash or itching ). Severe emgality 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 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 emgality side effects that have been reported:
A very common side effect of emgality is (can occur in more than 1 in 10):
- Injection site pain
- Injection site reactions (eg skin redness, itching, bruising, swelling).
Common mgality 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 of emgality, 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 the 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.
- This medicine 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 Emgality pen 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
- 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.