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.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them..
• If you experience adverse effects, consult your doctor, pharmacist, or nurse,even if they do not appear in this prospect. See section4.

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:

• one injection (225 mg) once a month (monthly dosage regimen) or
• three injections (675 mg) every three months (trimestral dosage regimen)

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

• The active ingredient is fremanezumab.

Each pre-filled syringe contains 225 mg of fremanezumab.

• The other components (excipients) are L-histidine, L-histidine hydrochloride monohydrate, sucrose, ethylenediaminetetraacetic acid (EDTA) dihydrate, polisorbate 80, and water for injections.

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.

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:

• Read the AJOVY package insert carefully for more information about the medicine.
• Do not pull the plunger rod, as the pre-filled syringe may break.
• Do not shake the pre-filled syringe.
• Immediately store the pack in the refrigerator if you have any unused pre-filled syringes in the pack.

Components of the pre-filled syringe of AJOVY

Step 1: Preparation for injection

1. Assemble the following material for your injection:
   • 1 or 3 pre-filled syringes of AJOVY to administer 1 or 3 injections depending on your dose
   • 1 alcohol swab for injection
   • 1 cotton ball or gauze for injection
   • 1 sharps container or puncture-resistant container
2. Place the material you have assembled on a clean and flat surface.
3. Wait 30 minutes for AJOVY to reach room temperature to reduce discomfort during injection.
   • Do not expose the pre-filled syringe to direct sunlight.
   • Do not heat the pre-filled syringe in a microwave or any other heat source.
   • Do not remove the needle cap.
4. Wash your hands with soap and water and dry them thoroughly.
5. Examine the pre-filled syringe of AJOVY.
   • Check the label on the pre-filled syringe. Ensure that the name AJOVY appears on the label.
   • Check that the medicine inside the pre-filled syringe is transparent and colourless to slightly yellowish.
   • You may see small air bubbles in the pre-filled syringe. This is normal.
   • Do not use the pre-filled syringe if you observe any of the following signs:
   • • The pre-filled syringe appears damaged.
     • Has expired or the pre-filled syringe has been out of the refrigerator for more than 7 days.
     • The medicine is cloudy, has changed colour, or contains particles.

1. Choose the injection site.
   • Chooseone of the following injection sites:
   • • the abdomen (stomach), avoiding a 5 cm margin around the navel
     • the anterior thigh, about 5 cm above the knee and 5 cm below the groin
     • the posterior arm, in the fleshy part of the arm
   • If multiple injections are required, they may be administered in the same site or different sites (abdomen, thigh, arm), but should avoid administering them exactly in the same place.

1. Clean the injection site.
   • Clean the chosen injection site using a new alcohol swab.
   • Wait 10 seconds for the skin to dry before administering the injection.
   • Do not inject AJOVY into a painful, red, warm, swollen, hardened, tattooed, or scarred area.

Step 2: How to inject

1. Only when ready to inject,pull the needle cap straight off and discard it.
   • Do not reattach the needle cap to the pre-filled syringe to avoid injury or infection.
   • Do not touch the needle.

1. Inject following the four steps outlined below.

1. Remove the needle from the skin.
   • Once all the medicine has been injected, pull the needle straight out.
   • Do not reattach the needle cap at any time to avoid injury or infection.

1. Apply pressure to the injection site.
   • Use a clean and dry cotton ball or gauze to apply gentle pressure to the injection site for a few seconds.
   • Do not rub the injection site or reuse the pre-filled syringe.

Step 3: Disposal of the pre-filled syringe

1. Dispose of the pre-filled syringe immediately.
   • Dispose of used pre-filled syringes (with the needle still attached) in a sharps container or puncture-resistant container just after use.
   • Do not dispose of loose needles, pre-filled syringes, or pre-filled syringe needles in the trash.
   • Do not recycle the used sharps container.
2. Ask your doctor, pharmacist, or nurse how to dispose of the container.

If your dose is 675 mg, repeat steps 1e) to 3a) with the second and third pre-filled syringes to administer the full dose.