Ajovy 225 mg solucion inyectable en pluma precargada

Product Information for the Patient

AJOVY 225mg Pre-filled Syringe Solution

fremanezumab

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them..
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse,even if they do not appear in this product information. 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 the 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 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 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 medication if you are allergic to fremanezumab or to any of the other components of this medication (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, difficulty breathing, 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 medication, 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 medications and AJOVY

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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 medication. It is preferable to avoid using AJOVY during pregnancy, as the effects of this medication on pregnant women are unknown.

If you are breastfeeding or intend to breastfeed, consult your doctor or pharmacist before starting to use this medication. 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 medication.

AJOVY contains sodium

This medication 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. 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 suitable dosing regimen. There are two alternative dosing regimens recommended:

• one injection (225 mg) once a month (monthly dosing regimen) or
• three injections (675 mg) every three months (trimestral dosing 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 all people 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 thepenlabel and on the outer packaging after “EXP”. The expiration date is the last day of the month indicated.

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

Store thepenpreloaded with medication 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 7days.The medication must be discarded if it has remained more than 7days 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, thepenis damaged, or the medication is cloudy, has changed color, or contains particles.

Thepenis for single use only.

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. In this way, you will help protect the environment.

Composition of AJOVY

• The active ingredient is fremanezumab.

Eachpre-filled syringe contains 225mg of fremanezumab.

• The other components (excipients) are L‑histidina, L‑histidina hydrochloride monohydrate, sacarosa, ethylenediaminetetraacetic acid (EDTA) disodium dihydrate, polisorbate80 and water for injection.

Appearance of the product and contents of the pack

AJOVY is a ready-to-use solution for injection in a pre-filled syringe. AJOVY is a transparent, colourless to slightly yellowish solution. Each pre-filled syringe contains 1.5ml of solution.

AJOVY is available in packs containing 1 or 3pre-filled syringes. Only some 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

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 225mg solution for injection in a 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 to obtain more information about the medicine.
• Do notshake the pre-filled syringe.
• Return the box to the refrigerator immediately,if there are any unused pre-filled syringes left in the box.

AJOVY pre-filled syringe (before use)

AJOVY pre-filled syringe (after use)

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

Step1: Preparation for injection

1. Gather the following material for your injection:
   • 1 or 3pre-filled syringes of AJOVY to administer 1 or 3injections depending on your dose
   • 1alcohol swab for injection
   • 1gauze or cotton ball for injection
   • 1sharps container or puncture-resistant container
2. Place the material you have gathered on a clean and flat surface.
3. Wait 30minutes to allow AJOVY to reach room temperature(<30°C)to reduce discomfort during injection.
   1. Do notleave the pre-filled syringe exposed to direct sunlight.
   2. Do notheat the pre-filled syringe in a microwave or any other heat source.
4. Wash your handswith soap and water and dry them well with a clean towel.
5. Examine the pre-filled syringe of AJOVY.
   • Check the label on the pre-filled syringe. Make sure the name AJOVY appears on the label.
   • Check that the medicine in the viewing window of 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 notuse the pre-filled syringe if you observe any of the following signs:
   • The pre-filled syringe appears damaged.
   • The expiration date has passedor the pre-filled syringe has been out of the refrigerator for more than 7days.
   • The medicine is cloudy, has changed colour, or contains particles.

1. Choose the injection site.
   • Choose one of the following injection sites:
   • • theabdomen, avoiding a 5cm margin around the navel
     • thefront of the thigh, about 5cm above the knee and 5cm below the groin
     • theback of the arm, in the fleshy part of the back of the arm
   • If more than one injection is required, they may be administered in the same site or in different sites (abdomen, thigh, arm), but they should not be administered exactly in the same place.

1. Clean the injection site.
   • Clean the chosen injection site using a new alcohol swab.
   • Wait 10seconds to allow the skin to dry before administering the injection.
   • Do notinject AJOVY into a painful, red, warm, swollen, hardened, tattooed, or scarred area.

Step2: How to inject

1. Remove the outer cap and do not replace it.
   • Pull the outer cap straight off.Do notrotate it.
   • Do notreplace the outer cap on the pre-filled syringe, in order to avoid injury or infection.
   • Do nottouch the needle shield.

1. Inject following the steps below.
   • Hold the pre-filled syringe at a 90° angle over the skin at the injection site.

• Press the pre-filled syringe and keep it pressed against the skin for about 30seconds.Do notrelease the pressure until you have completed the 3steps below.

1. Check that the blue plunger has occupied the entire viewing window and remove the pre-filled syringe from the skin.

• Once all the medicine has been injected, that is, when the blue plunger has occupied the entire viewing window and you can see the grey stopper, lift the pre-filled syringe straight up to remove it from the skin and dispose of it immediately in a sharps container (see step3).
• When lifting the pre-filled syringe from the skin, the needle shield will return to its original position and lock, covering the needle.
• Do notreplace the outer cap of the pre-filled syringe at any time, in order to avoid injury or infection.

1. Apply pressure to the injection site.
   • Use a clean and dry cotton ball or gauze to applygentlepressure to the injection site for a few seconds.
   • Do notrub the injection site or reuse the pre-filled syringe.

Step3: Disposal of the pre-filled syringe

1. Dispose of the pre-filled syringe immediately.
   • Dispose of the used pre-filled syringes in a sharps container just after use.
   • Do notthrow (dispose of) the pre-filled syringes in the trash.
   • Do notrecycle the used sharps container.
2. Ask your doctor, pharmacist, or nurse how to dispose of the container.

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