Ajovy 225 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

AJOVY 225 mg solution for injection in pre-filled syringe

fremanezumab

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What AJOVY is and what it is used for
2. What you need to know before using AJOVY
3. How to use AJOVY
4. Possible side effects
5. How to store AJOVY
6. Contents of the pack and other information

1. What AJOVY is and what it is used for

What AJOVY is

AJOVY is a medicine that contains the active substance fremanezumab, a monoclonal antibody, a type of protein that recognises 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 reduction in CGRP activity reduces migraine attacks.

What AJOVY is used for

AJOVY is used to prevent migraine in adults who have at least four migraine days per month.

What benefits of using AJOVY

AJOVY reduces the frequency of migraine attacks and the number of headache days. This medicine also decreases migraine-related disability and reduces the need for medications to treat migraine attacks.

2. What you need to know before using 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

Contact your doctor, pharmacist, or nurse immediately if you notice any signs of a serious allergic reaction, such as difficulty breathing, swelling of the lips and tongue, or severe skin rash, after an injection of AJOVY. These reactions may occur within 24 hours after administration of AJOVY, although sometimes they may appear later.

Inform your doctor if you have or have had any cardiovascular disease (conditions affecting the heart and blood vessels) before starting this medicine, as AJOVY has not been studied in patients with certain cardiovascular diseases.

Children and adolescents

The use of AJOVY is not recommended in children and adolescents under 18 years of age, as it has not been studied in this age group.

Other medicines and AJOVY

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. It is preferable to avoid the use of AJOVY during pregnancy, as the effects of this medicine in pregnant women are unknown.

If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before starting this medicine. You and your doctor should decide whether you will use AJOVY during breastfeeding.

Driving and using machines

This medicine is not expected to have any effect on your ability to drive or operate machinery.

AJOVY contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; essentially, it is "sodium-free".

3. How to use AJOVY

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Read the “Instructions for use” of the pre-filled syringe carefully before starting to use AJOVY.

How much and when to inject

Your doctor will discuss and decide with you the most appropriate dosing regimen. There are two alternative recommended dosing regimens:

• one injection (225 mg) once a month (monthly dosing regimen), or
• three injections (675 mg) every three months (quarterly dosing regimen)

If your dose is 675 mg, administer the three injections one after the other, each at a different site.

AJOVY is administered by injection under the skin (subcutaneous injection). 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 shown you or your caregiver how to do it.

Use a reminder method such as notes on a calendar or diary to help you remember when your next dose is due, so you do 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 forget or miss a dose of AJOVY

If you miss a dose of AJOVY, inject the missed dose as soon as possible. Do not administer a double dose to make up for 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 medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause 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, 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)

Skin rash at the injection site

Allergic reactions such as rash, swelling or urticaria

Rare (may affect up to 1 in 1,000 people)

Severe allergic reactions (symptoms may include breathing difficulties, swelling of the lips and tongue, or severe skin rash) (see section 2, “Warnings and precautions”).

Reporting of 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 leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of AJOVY

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the syringe label and outer packaging after "EXP". The expiry date refers to the last day of the month indicated.

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

Keep the pre-filled syringe in the outer packaging to protect the medicine from light.

This medicine can be removed from the refrigerator and stored at a temperature up to 30 °C for a maximum period of 7 days. The medicine must be discarded if it has been kept outside the refrigerator for more than 7 days. Once stored at room temperature, do not return it to the refrigerator.

Do not use this medicine if you notice that the outer packaging has been tampered with, the syringe is damaged, or if the solution is cloudy, has changed colour, or contains particles.

The syringe is for single use only.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of AJOVY

• The active substance is fremanezumab.

Each pre-filled syringe contains 225 mg of fremanezumab.

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

Description of the product and contents of the pack

AJOVY is an injectable solution 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 of solution.

AJOVY is available in packs containing 1 or 3 pre-filled syringes. Only certain pack sizes may 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

The Netherlands

Further information on this medicinal product is available upon request from the local representative of the Marketing Authorisation Holder.

Date of the last review of this leaflet: {month YYYY}.

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

Instructions for use

AJOVY 225mg solution for injection in a prefilled syringe

fremanezumab

Before using the AJOVY prefilled syringe, read and carefully follow the step-by-step instructions.

Important information:

• Read the AJOVY patient information leaflet carefully for more information about the medicine.
• Do not pull back on the plunger, as the prefilled syringe may break.
• Do not shake the prefilled syringe.
• Return the carton to the refrigerator immediately if you have any unused prefilled syringes in the carton.

Components of the AJOVY prefilled syringe

Step 1: Preparing for an injection

1. Gather the following materials for your injection:
   • 1 or 3 AJOVY prefilled syringes, to administer 1 or 3 injections depending on your dose
   • 1 alcohol swab per injection
   • 1 gauze pad or cotton ball per injection
   • 1 sharps container or puncture-resistant container for disposal
2. Place the materials you have gathered on a clean, flat surface.
3. Wait 30 minutes to allow AJOVY to reach room temperature to reduce discomfort during injection.
   • Do not leave the prefilled syringe exposed to direct sunlight.
   • Do not heat the prefilled syringe in a microwave or with any other heat source.
   • Do not remove the needle cap.
4. Wash your hands with soap and water and dry them thoroughly with a clean towel.
5. Inspect the AJOVY prefilled syringe.
   • Check the syringe label. Make sure the name AJOVY appears on the label.
   • Check that the medicine inside the syringe is clear and colourless to slightly yellow.
   • Small air bubbles may be visible in the prefilled syringe. This is normal.
   • Do not use the prefilled syringe if you notice any of the following:
     • The syringe appears damaged.
     • The expiry date has passed or the prefilled syringe has been kept outside the refrigerator for more than 7 days.
     • The medicine is cloudy, has changed colour, or contains particles.

1. Choose the injection site.
   • Select one of the following injection sites:
     • the abdomen, avoiding a 5 cm area around the navel
     • the front of the thighs, about 5 cm above the knee and 5 cm below the groin
     • the back of the upper arms, in the fleshy area of the back of the arm
   • If more than one injection is required, they may be administered in the same area or in different areas (abdomen, thigh, arm), but avoid injecting exactly at the same spot.

1. Clean the injection site.
   • Clean the chosen injection site using a new alcohol swab.
   • Wait 10 seconds to allow the skin to dry before administering the injection.
   • Do not inject AJOVY into an area that is tender, red, warm, bruised, hard, tattooed, or has scars or stretch marks.

Step 2: How to inject

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

1. Inject by following the four steps shown below.

1. Remove the needle from the skin.
   • Once the full dose of medication has been injected, pull the needle straight out.
   • Do not recap the needle at any time to avoid injury or infection.

1. Apply pressure to the injection site.
   • Use a clean, dry cotton ball or gauze pad to gently press on the injection site for several seconds.
   • Do not rub the injection site, and do not reuse the prefilled syringe.

Step 3: Disposal of the prefilled syringe

1. Dispose of the prefilled syringe immediately.
   • Place used prefilled syringes (with the needle still attached) into a sharps disposal container right after use.
   • Do not throw loose needles, syringes, or prefilled syringes into the trash.
   • Do not recycle the used sharps disposal 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 prefilled syringe to administer the complete dose.