Ajovy 225 mg solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

AJOVY 225 mg solution for injection in a pre-filled pen

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 may 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 containing 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 decreases 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 the benefits of using AJOVY are

AJOVY reduces the frequency of migraine attacks and the number of headache days. This medicine also reduces migraine-related disability and decreases 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 to 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 severe allergic reaction, such as difficulty breathing, swelling of the lips and tongue, or severe skin rash, after receiving an AJOVY injection. These reactions may occur within 24 hours of administration of AJOVY, although they can sometimes 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

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

Tell your doctor or pharmacist if you are using, have recently used, or might need to use 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 will need to decide whether you should use AJOVY while 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; this is essentially "sodium-free".

3. How to use AJOVY

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

Read carefully the "Instructions for use" of the pre-filled pen 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 recommended alternative 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 further questions about 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 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 hives

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

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

Reporting of side effects

If you experience any type of side effect, talk to your doctor, pharmacist or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting side 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 pen 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 pen in the outer packaging 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 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 pen is damaged, or if the medicine is cloudy, has changed colour, or contains particles.

The pen is for single use only.

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

6. Contents of the pack and other information

Composition of AJOVY

• The active substance is fremanezumab.

Each pre-filled pen contains 225 mg of fremanezumab.

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

Appearance of the product and contents of the pack

AJOVY is an injectable solution (injectable) in a single-dose pre-filled pen. AJOVY is a clear, colourless to slightly yellow solution. Each pre-filled pen contains 1.5 ml of solution.

AJOVY is available in packs containing 1 or 3 pre-filled pens. Only certain pack sizes may be available in your country.

Marketing Authorization Holder

TEVA GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Manufacturer responsible for manufacturing

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 by contacting the local representative of the Marketing Authorization Holder.

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

Other sources of information

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

Instructions for use

AJOVY 225 mg solution for injection in a pre-filled pen

fremanezumab

Before using the AJOVY pre-filled pen, 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 shake the pre-filled pen.
• Return the carton to the refrigerator immediately if you have any unused pre-filled pens in the carton.

AJOVY pre-filled pen (before use)

AJOVY pre-filled pen (after use)

• The blue plunger moves down in the viewing window during injection. The blue plunger will fill the entire viewing window when the injection is complete. (Note: when the blue plunger has filled the entire viewing window, you will still see the grey stopper.)
• When injecting AJOVY, hold the pre-filled pen so that your hand does not cover the viewing window.

Step 1: Preparing for an injection

1. Gather the following materials for your injection:
   • 1 or 3 AJOVY pre-filled pens, 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 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 (<30°C) to reduce discomfort during injection.
   1. Do not leave the pre-filled pen exposed to direct sunlight.
   2. Do not heat the pre-filled pen in a microwave or with any other heat source.
4. Wash your hands with soap and water and dry them thoroughly with a clean towel.
5. Inspect the AJOVY pre-filled pen.
   • Check the label on the pen. Make sure the name AJOVY appears on the label.
   • Check that the medicine in the viewing window of the pen is clear and colourless to slightly yellow.
   • Small air bubbles may be visible in the pre-filled pen. This is normal.
   • Do not use the pre-filled pen if you observe any of the following:
   • The pen appears damaged.
   • The expiry date has passed or the pre-filled pen 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 abdominal area (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 upper arm
   • If more than one injection is required, they may be given in the same area or in different areas (abdomen, thigh, arm), but should not be administered in exactly 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, hardened, tattooed, or has scars or stretch marks.

Step 2: How to inject

1. Remove the outer cap and do not replace it.
   • Pull the outer cap straight off. Do not twist it.
   • Do not replace the outer cap on the pre-filled pen to avoid injury or infection.
   • Do not touch the needle shield area.

1. Inject by following the steps below.
   • Place the pre-filled pen at a 90° angle against the skin at the injection site.

• Press the pre-filled pen down and keep it pressed against the skin for about 30 seconds. Do not stop pressing until you have completed the next 3 steps.

1. Ensure that the blue plunger has filled the entire viewing window and remove the prefilled pen from the skin.

• Once the entire medication has been injected, that is, when the blue plunger has filled the entire viewing window and you can see the gray plunger stopper, lift the prefilled pen straight up and away from the skin and dispose of it immediately in a sharps disposal container (see step 3).
• When lifting the prefilled pen from the skin, the needle shield will return to its original position and lock into place, covering the needle.
• Do not replace the outer cap on the prefilled pen at any time to avoid injury or infection.

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

Step 3: Disposal of the prefilled pen

1. Dispose of the prefilled pen immediately.
   • Place used prefilled pens into a sharps disposal container immediately after use.
   • Do not throw (dispose of) prefilled pens into household 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 pen to administer the complete dose.