Prospect: information for the patient
AJOVY 225mg injectable solution in pre-filled syringe
fremanezumab
Read this prospect carefully before starting to use this medication, because it contains important information for you.
1.What is AJOVY and for what it is used
2.What you need to know before starting to use AJOVY
3.How to use AJOVY
4.Possible adverse effects
5.Storage of AJOVY
6.Contents of the package and additional information
What is AJOVY
AJOVY is a medication that contains the active ingredient fremanezumab, a monoclonal antibody, a type of protein that recognizes and binds 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 binds to CGRP and prevents it from acting. This decrease in CGRP activity reduces migraine attacks.
What AJOVY is used for
AJOVY is used to prevent migraine in adults with at least four days of migraine per month.
What are the benefits of using AJOVY
AJOVY reduces the frequency of migraine attacks and the number of days with headache. This medication also decreases the disability associated with migraine and reduces the need for medications to treat migraine attacks.
Do not use AJOVY
Do not use this medicine if you are allergic to fremanezumab or to any of the other components of this medicine (listed in section6).
Warnings and precautions
Consult your doctor, pharmacist, or nurse immediately if you notice any signs of a severe allergic reaction such as, for example, breathing difficulties, swelling of the lips and tongue, or severe skin rash, after the injection of AJOVY. These reactions can occur within 24hours after administration of AJOVY, although they can sometimes appear later.
Inform your doctor if you have or have had any cardiovascular disease (problems affecting the heart and blood vessels) before starting to use this medicine, as AJOVY has not been studied in patients with certain cardiovascular diseases.
Children and adolescents
AJOVY is not recommended for use in children and adolescents under 18years as it has not been studied in this age group.
Other medicines and AJOVY
Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine. It is preferable to avoid using AJOVY during pregnancy, as the effects of this medicine on pregnant women are unknown.
If you are breastfeeding or intend to breastfeed, consult your doctor or pharmacist before starting to use this medicine. You and your doctor will need to decide whether to use AJOVY during breastfeeding.
Driving and operating machinery
No effect on your ability to drive and operate machinery is expected from this medicine.
AJOVY contains sodium
This medicine contains less than 1mmol of sodium (23mg) per dose; essentially “sodium-free”.
Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
Read carefully the "Instructions for use" of the pre-filled syringe before starting to use AJOVY.
How much and when to inject
Your doctor will discuss and decide with you the most suitable dosage regimen. There are two alternative dosage regimen options recommended:
If your dose is 675 mg, administer the three injections one after the other, in a different location each one.
AJOVY is administered by subcutaneous injection under the skin. Your doctor or nurse will explain to you or your caregiver how to administer the injection. Do not inject AJOVY until your doctor or nurse has taught you or your caregiver how to do it.
Use some method of reminder, such as notes in a calendar or diary, to help you remember the next dose and thus not miss a dose or inject 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, consult your doctor.
If you forgot or omitted using AJOVY
If you have missed a dose of AJOVY, inject the missed dose as soon as possible. Do not administer a double dose to compensate for the missed doses. If you are unsure when to inject AJOVY, consult your doctor, pharmacist, or nurse.
If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.
Like all medications, this medication may produce adverse effects, although not everyone will experience them.
The following adverse effects may occur:
Very common (may affect more than 1 in 10 people)
Pain, hardness, 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)
Skin eruption at the injection site
Allergic reactions such as urticaria, swelling, or hives
Rare (may affect up to 1 in 1,000 people)
Severe allergic reactions (symptoms may include difficulty breathing, swelling of the lips and tongue, or severe skin eruption) (see section 2. “Warnings and Precautions”).
Reporting Adverse Effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus.You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the syringe label and on the outer packaging after “EXP”. The expiration date is the last day of the month indicated.
Store in refrigerator (between 2°C and 8°C). Do not freeze.
Store the pre-filled syringe in the outer packaging to protect the medication from light.
This medication may be removed from the refrigerator and stored at a temperature of up to 30°C for a maximum period of 7 days.The medication must be discarded if it has remained more than 7 days outside the refrigerator.Once stored at room temperature, do not return it to the refrigerator.
Do not use this medication if you observe that the outer packaging has been manipulated, the syringe is damaged, or the medication is cloudy, has changed color, or contains particles.
The syringe is for single use.
Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.
Composition of AJOVY
Each pre-filled syringe contains 225 mg of fremanezumab.
Appearance of the product and contents of the pack
AJOVY is a pre-filled syringe with a fixed needle in a blister pack. AJOVY is a transparent, colourless to slightly yellowish solution. Each pre-filled syringe contains 1.5 ml of solution.
AJOVY is available in packs containing 1 or 3 pre-filled syringes. Some pack sizes may not be available in your country.
Marketing Authorisation Holder
TEVA GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
Manufacturer
Merckle GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
Teva Pharmaceuticals Europe B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
You can request more information about this medicine by contacting the local representative of the marketing authorisation holder.
Belgium/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tel: +32 38207373 | Lithuania UAB Teva Baltics Tel: +370 52660203 |
Bulgaria Teva Pharmaceuticals S.R.L. Tel: +359 24899585 | Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Belgium/Belgien Tel: +32 38207373 |
Czech Republic Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111 | Hungary Teva Gyógyszergyár Zrt. Tel: +36 1 2886400 |
Denmark Teva Denmark A/S Tel: +45 44985511 | Malta Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407117 |
Germany TEVA GmbH Tel: +49 73140208 | Netherlands Teva Nederland B.V. Tel: +31 8000228400 |
Estonia UAB Teva Baltics Estonian branch Tel: +372 6610801 | Norway Teva Norway AS Tel: +47 66775590 |
Greece TEVA HELLAS Α.Ε. Tel: +30 2118805000 | Austria ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070 |
Spain Teva Pharma, S.L.U. Tel: +34 913873280 | Poland Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300 |
France Teva Santé Tel: +33 155917800 | Portugal Teva Pharma - Produtos Farmacêuticos, Lda. Tel: +351 214767550 |
Croatia Pliva Hrvatska d.o.o. Tel: +385 13720000 | Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524 |
Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117 | Slovenia Pliva Ljubljana d.o.o. Tel: +386 15890390 |
Iceland Teva Pharma Iceland ehf. Tel: +354 5503300 | Slovakia TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911 |
Italy Teva Italia S.r.l. Tel: +39 028917981 | Finland Teva Finland Oy Tel: +358 201805900 |
Cyprus TEVA HELLAS Α.Ε. Greece Tel: +30 2118805000 | Sweden Teva Sweden AB Tel: +46 42121100 |
Latvia UAB Teva Baltics filiale Latvija Tel: +371 67323666 | United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407117 |
Last update of the summary of product characteristics:{month YYYY}.
Other sources of information
Further information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.
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Instructions for use
AJOVY 225 mg solution for injection in pre-filled syringe
fremanezumab
Before using the pre-filled syringe of AJOVY, read and carefully follow the step-by-step instructions.
Important information:
Components of the pre-filled syringe of AJOVY
Step 1: Preparation for injection
Step 2: How to inject
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Step 3: Disposal of the pre-filled syringe
If your dose is 675 mg, repeat steps 1e) to 3a) with the second and third pre-filled syringes to administer the full dose.
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.