AJOVY 225 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN

Introduction

Package Leaflet: Information for the Patient

AJOVY 225mg solution for injection in pre-filled pen

fremanezumab

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is AJOVY and what is it used for

What is AJOVY

AJOVY is a medicine that contains the active substance 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 working. This reduction in CGRP activity reduces migraine attacks.

What AJOVY is used for

AJOVY is used to prevent migraine in adults with at least 4 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 medicine also reduces the disability associated with migraine and decreases the need to use medicines 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

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

Tell 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 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 use any other medicines.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan 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 plan to breastfeed, consult your doctor or pharmacist before starting to use this medicine. You and your doctor will decide whether to use AJOVY during breastfeeding.

Driving and using machines

This medicine is not expected to have any effect on your ability to drive and use machines.

AJOVY contains sodium

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

3. How to use AJOVY

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, 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 suitable dosage regimen. There are two alternative dosage regimens recommended:

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

If your dose is 675 mg, administer the three injections one after the other, in a different place each time.

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 taught you or your caregiver how to do it.

Use some reminder method, such as notes on a calendar or diary, to help you remember the next dose and 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 miss a dose of AJOVY

If you have missed 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 you should 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 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 exanthema, swelling, or urticaria

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

Severe allergic reactions (signs may be breathing problems, swelling of the lips and tongue, or severe skin rash) (see section 2 "Warnings and precautions").

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed 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 which is stated on the label of the pen and on the outer packaging after "EXP". The expiry date is the last day of the month shown.

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 can be taken out of the refrigerator and stored at a temperature not above 30°C for a maximum period of 7 days. The medicine should be discarded if it has been out of the refrigerator for more than 7 days. Once stored at room temperature, do not put it back in the refrigerator.

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

The pen is for single use.

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

6. Container Contents and Additional Information

AJOVY Composition

• The active ingredient is fremanezumab.

Each pre-filled pen contains 225 mg of fremanezumab.

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

Product Appearance and Container Contents

AJOVY is an injectable solution in a single-dose pre-filled pen. AJOVY is a clear, colorless 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. Not all pack sizes may be available in your country.

Marketing Authorization 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 medicinal product from the local representative of the marketing authorization holder.

Date of Last Revision of this Leaflet:{Month YYYY}.

Other Sources of Information

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

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Instructions for Use

AJOVY 225 mg Solution for Injection in Pre-filled Pen

fremanezumab

Before Using the AJOVY Pre-filled Pen, Read and Follow the Instructions Carefully Step by Step.

Important Information:

• Read the AJOVY leaflet carefully to get more information about the medicine.
• Do notshake the pre-filled pen.
• Put the box back in the refrigerator immediatelyif you have any unused pre-filled pens in the box.

AJOVY Pre-filled Pen (Before Use)

AJOVY Pre-filled Pen (After Use)

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

Step 1: Preparation for 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 cotton ball or swab per injection
   • 1 container for disposing of sharp objects or a puncture-resistant container
2. Place the Gathered Materials 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 notexpose the pre-filled pen to direct sunlight.
   2. Do notheat the pre-filled pen in a microwave or with any other heat source.
4. Wash Your Handswith water and soap and dry them well with a clean towel.
5. Inspect the AJOVY Pre-filled Pen.
   • Check the label on the pre-filled pen. Make sure the name AJOVY appears on the label.
   • Check that the medicine in the viewing window of the pre-filled pen is clear and colorless to slightly yellow.
   • You may see small air bubbles in the pre-filled pen. This is normal.
   • Do notuse the pre-filled pen if you notice any of the following signs:
   • The pre-filled pen appears damaged.
   • The expiration date has passed or the pre-filled pen has been out of the refrigerator for more than 7 days.
   • The medicine is cloudy, has changed color, or contains particles.

1. Choose the Injection Site.
   • Choose one of the following injection sites:
   • • the abdomen(stomach area), avoiding a 5 cm margin around the navel
     • the front of the thighs, about 5 cm above the knee and 5 cm below the groin
     • the back of the arms, in the fleshy areas of the back of the arm
   • If more than one injection is required, they can be administered in the same area or in different areas (abdomen, thigh, arm), but avoid administering them exactly in 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 notinject AJOVY into an area that is painful, red, hot, bruised, hardened, 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 nottwist it.
   • Do notput the outer cap back on the pre-filled pen to avoid injury or infection.
   • Do nottouch the needle shield area.

1. Inject Following the Steps Below.
   • Place the pre-filled pen at a 90° angle to the skin at the injection site.

• Press the pre-filled pen and hold it against the skin for about 30 seconds. Do notrelease pressure until you have completed the next 3 steps.

1. Check That the Blue Plunger Has Occupied the Entire Viewing Window and Remove the Pre-filled Pen from the Skin.

• Once all the medicine has been injected, i.e., when the blue plunger has occupied the entire viewing window and you can see the gray plug, lift the pre-filled pen straight up to remove it from the skin and dispose of it immediately in a puncture-resistant container (see step 3).
• When lifting the pre-filled pen from the skin, the needle shield will return to its original position and lock, covering the needle.
• Do notput the outer cap back on the pre-filled pen at any time to avoid injury or infection.

1. Apply Pressure to the Injection Site.
   • Use a clean, dry cotton ball or swab to apply gentle pressure to the injection site for a few seconds.
   • Do notrub the injection site or reuse the pre-filled pen.

Step 3: Disposal of the Pre-filled Pen

1. Dispose of the Pre-filled Pen Immediately.
   • Throw away used pre-filled pens in a puncture-resistant container right after use.
   • Do notthrow (dispose of) pre-filled pens in the trash.
   • Do notrecycle the used puncture-resistant container.
2. Ask Your Doctor, Pharmacist, or Nurse How to Dispose of the Container.

If Your Dose is 675 mg, Repeat Steps 1 to 3 with the Second and Third Pre-filled Pens to Administer the Full Dose.