Patient leaflet - Ajovy 225 mg solution for injection in Pre-filled syringe
1. What AJOVY is and what it is used for
What AJOVY is
AJOVY is a medicine containing the active substance fremanezumab, a monoclonal antibody, a type of protein that recognises and attaches to a specific target in the body.
How AJOVY works
A substance in the body called calcitonin gene-related peptide (CGRP) plays an important role in migraine. Fremanezumab attaches to CGRP and prevents it from working. This reduction in CGRP's activity reduces migraine attacks.
What AJOVY is used for
AJOVY is used to prevent migraine in adults who have at least 4 migraine days per month.
What are the benefits of using AJOVY
AJOVY reduces the frequency of migraine attacks and days with headache. This medicine also decreases the disability associated with migraine and it reduces the need for medicines used to treat migraine attacks.
2. What you need to know before you use AJOVY
Do not use AJOVY
Do not use this medicine if you are allergic to fremanezumab or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse immediately if you get any signs of a serious allergic reaction, e.g. trouble breathing, swelling of the lips and tongue, or severe rash, after injecting AJOVY. These reactions can occur within 24 hours after using AJOVY but can sometimes be delayed.
Tell your doctor if you have or have had cardiovascular disease (problems affecting the heart and blood vessels) before using this medicine, because AJOVY has not been studied in patients with certain cardiovascular diseases.
Children and adolescents
AJOVY is not recommended for children and adolescents below the age of 18 years because it has not been studied in this age group.
Other medicines and AJOVY
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is preferable to avoid the use of AJOVY during pregnancy as the effects of this medicine in pregnant women are not known.
If you are breast-feeding or are planning to breast-feed, talk to your doctor or pharmacist before using this medicine. You and your doctor should decide if you will use AJOVY while breast-feeding.
Driving and using machines
This medicine is not expected to have any effect on your ability to drive or use machines.
AJOVY contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially “sodium-free”.
3. How to use AJOVY
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
AJOVY is given by injection under your skin (subcutaneous injection). Your doctor or nurse will explain to you or your caregiver how to give the injection. Do not inject AJOVY until you or your caregiver have been trained by your doctor or nurse.
Read the “Instructions for Use” for the pre-filled syringe carefully before using AJOVY.
How much and when to inject
Your doctor will discuss and decide with you the most appropriate dosing schedule. There are two alternative recommended dosing options:
- one injection (225 mg) once a month (monthly dosing) or
- three injections (675 mg) every 3 months (quarterly dosing)
If your dose is 675 mg, inject the three injections one after another, each in a different place.
Use a reminder method such as notes in a calendar or diary to help you remember your next dose so that you do not miss a dose or have a dose too soon after the last one.
If you use more AJOVY than you should
If you have used more AJOVY than you should, tell your doctor.
If you forget or miss to use AJOVY
If you have missed a dose of AJOVY, inject your missed dose as soon as you can. Do not take a double dose to make up for a forgotten dose. If you are not sure when to inject AJOVY, talk to your doctor, pharmacist or nurse.
If you have any further 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.
The following side effects can occur:
Very common (may affect more than 1 in 10 people)
Pain, hardening or redness at the injection site
Common (may affect up to 1 in 10 people)
Itching at the injection site
Uncommon (may affect up to 1 in 100 people)
Rash at the injection site
Allergic reactions such as rash, swelling or hives (see section 2)
Rare (may affect up to 1 in 1000 people)
Serious allergic reactions (signs may include trouble breathing, swelling of the lips, tongue or severe rash) (see section 2. “Warnings and precautions”).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store AJOVY
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 syringe label and on the outer carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled syringe in the outer carton to protect the medicine from light.
This medicine may be removed from the refrigerator and stored at a temperature up to 30 °C for a maximum period of up to 7 days. The medicine must be discarded if it has been out of the refrigerator for longer than 7 days. Once stored at room temperature, do not place back in the refrigerator.
Do not use this medicine if you notice that the outer carton has been tampered with, the syringe is damaged, or the medicine is cloudy, discoloured, or contains particles.
The syringe is for single use only.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What AJOVY contains
The active substance is fremanezumab.
Each pre-filled syringe contains 225 mg of fremanezumab.
- The other ingredients (excipients) are L-histidine, L-histidine hydrochloride monohydrate, sucrose, disodium ethylenediaminetetraacetic acid (EDTA) dihydrate, polysorbate 80 and water for injections.
What AJOVY looks like and contents of the pack
AJOVY is a solution for injection (injection) in a pre-filled syringe with a fixed injection needle in a blister. AJOVY is a clear, colourless to slightly yellow solution. Each pre-filled syringe contains 1.5 mL solution.
AJOVY is available in packs containing 1 or 3 pre-filled syringes. Not all pack sizes may be available in your country.
Marketing Authorisation Holder
Teva UK Limited, Ridings Point, Whistler Drive, Castleford, WF10 5HX, United Kingdom
Manufacturer
Merckle GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany
This leaflet was last revised in February 2024.
PLGB 00289/2461
159081_s1 fremanezumab