Aimovig - patient leaflet, side effects, dosage

1. What Aimovig is and what it is used for

Aimovig contains the active substance erenumab. It belongs to a group of medicines called monoclonal antibodies.

Aimovig works by blocking the activity of the CGRP molecule, which has been linked to migraine (CGRP stands for calcitonin gene-related peptide).

Aimovig is used to prevent migraine in adults who have at least 4 migraine days per month when starting treatment with Aimovig.

2. What you need to know before you use Aimovig

Do not use Aimovig

• – if you are allergic to erenumab or any of the other ingredients of this medicine (listed in

section 6).

Warnings and precautions

Talk to your doctor before using Aimovig:

• – if you have ever had an allergic reaction to rubber latex. The container of this medicinal product

contains latex rubber within the cap.

• – if you suffer from a cardiovascular disease. Aimovig has not been studied in patients with

certain cardiovascular diseases.

Talk to your doctor or get emergency medical help immediately:

• – if you get any symptoms of a serious allergic reaction, such as rash or swelling usually of the

face, mouth, tongue, or throat; or difficulty breathing. Serious allergic reactions can happen within minutes, but some may happen more than one week after using Aimovig.

• – Contact a doctor if you get constipation and seek medical help immediately if you develop

constipation with severe or constant belly (abdominal) pain and vomiting, swelling of abdomen or bloating. Constipation can occur when treated with Aimovig. It is usually mild or moderate in intensity. However, some patients using Aimovig have had constipation with serious complications and have been hospitalised. Some cases have required surgery.

Children and adolescents

Do not give this medicine to children or adolescents (under 18 years old) because the use of Aimovig has not been studied in this age group.

Other medicines and Aimovig

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Pregnancy

Your doctor will decide whether you should stop using Aimovig during pregnancy.

Breast-feeding

Monoclonal antibodies.like Aimovig are known to pass into breast milk during the first few days after birth, but after this first period Aimovig can be used. Talk to your doctor about using Aimovig while breast-feeding in order to help you decide whether you should stop breast-feeding or stop using Aimovig.

Driving and using machines

Aimovig is unlikely to affect your ability to drive and use machines.

Aimovig contains sodium

Aimovig contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.

3. How to use Aimovig

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

If you have not noticed any treatment effect after 3 months, tell your doctor who will decide whether you should continue treatment.

Use Aimovig exactly as prescribed by your doctor. If your doctor prescribes the 70 mg dose you should have one injection once every 4 weeks. If your doctor prescribes the 140 mg dose you should have either one injection of Aimovig 140 mg or two injections of Aimovig 70 mg once every 4 weeks. If you are having two injections of Aimovig 70 mg, the second injection must be given immediately after the first one at a different injection site. Make sure that you inject the entire contents of both syringes.

Aimovig is given as an injection under your skin (known as a subcutaneous injection). You or your caregiver can give the injection into your abdomen or your thigh. The outer area of your upper arm can also be used as an injection site, but only if someone else is giving you the injection. If you need 2 injections, they should be given in different sites to avoid hardening of the skin and should not be given into areas where the skin is tender, bruised, red or hard.

Your doctor or nurse will give you or your caregiver training in the right way to prepare and inject Aimovig. Do not try to inject Aimovig until this training has been given.

Aimovig syringes are for single use only.

For detailed instructions on how to inject Aimovig, see “Instructions for use of Aimovig pre-filled syringe” at the end of this leaflet.

If you use more Aimovig than you should

If you have received more Aimovig than you should or if the dose has been given earlier than it should have been, tell your doctor.

If you forget to use Aimovig

• – If you forget an Aimovig dose, take it as soon as possible after you realise.

• – Then contact your doctor, who will tell you when you should schedule your next dose. Follow

the new schedule exactly as your doctor has told you.

If you stop using Aimovig

Do not stop using Aimovig without talking to your doctor first. Your symptoms may return if you stop the treatment.

If you have any further questions on 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.

Possible side effects are listed below. Most of these side effects are mild to moderate.

Common: may affect up to 1 in 10 people

• – allergic reactions such as rash, swelling, hives or difficulty breathing (see section 2)

• – constipation

• – itching

• – muscle spasms

• – injection site reactions, such as pain, redness and swelling where the injection is given.

Aimovig may cause skin reactions such as rash, itching, hair loss or mouth/lip sores.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Aimovig

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 and carton after EXP. The expiry date refers to the last day of that month.

Keep the syringe(s) in the outer carton in order to protect from light. Store in a refrigerator (2°C –8°C). Do not freeze.

After Aimovig has been taken out of the refrigerator, it must be kept at room temperature (up to 25°C) in the outer carton and must be used within 7 days, or else discarded. Do not put Aimovig back in the refrigerator once it has been removed.

Do not use this medicine if you notice that the solution contains particles, is cloudy or is distinctly yellow.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. There may be local regulations for disposal. These measures will help protect the environment.

6. Contents of the pack and other information

What Aimovig contains

• – The active substance is erenumab.

• – Aimovig 70 mg solution for injection in pre-filled syringe contains 70 mg erenumab.

• – Aimovig 140 mg solution for injection in pre-filled syringe contains 140 mg erenumab.

• – The other ingredients are sucrose, polysorbate 80, sodium hydroxide, glacial acetic acid, water

for injections.

What Aimovig looks like and contents of the pack

Aimovig solution for injection is clear to opalescent, colourless to light yellow, and practically free from particles.

Each pack contains one single-use pre-filled syringe.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Alcon-Couvreur

Rijksweg 14

B-2870 Puurs

Belgium

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgiqu­e/Belgien Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11	Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50
Efc^rapufl Novartis Bulgaria EOOD Ten: +359 2 489 98 28	Luxembourg/Lu­xemburg Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11
Česká republika Novartis s.r.o. Tel: +420 225 775 111	Magyarország Novartis Hungária Kft. Tel.: +36 1 457 65 00
Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 00	Malta Novartis Pharma Services Inc. Tel: +356 2122 2872
Deutschland Novartis Pharma GmbH Tel: +49 911 273 0	Nederland Novartis Pharma B.V. Tel: +31 88 04 52 111
Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810	Norge Novartis Norge AS Tlf: +47 23 05 20 00
EÀÀàôa Novartis (Hellas) A.E.B.E. Tql: +30 210 281 17 12	Österreich Novartis Pharma GmbH Tel: +43 1 86 6570
España Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00	Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
France Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00	Portugal Novartis Farma – Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600
Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 220	România Novartis Pharma Services Romania SRL Tel: +40 21 31299 01
Ireland Novartis Ireland Limited Tel: +353 1 260 12 55	Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 50
Ísland Vistor hf. Sími: +354 535 7000	Slovenská republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5439
Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1	Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200

United Kingdom (Northern Ireland)

Novartis Ireland Limited

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Instructions for use of Aimovig pre-filled syringe

Illustration of the syringe

Before use

General

Before you use the Aimovig pre-filled syringe, read this important information:

Step 1: Prepare

Note: The prescribed dose of Aimovig is either 70 mg or 140 mg. This means that for the 70 mg dose you must inject the contents of one 70 mg single-use syringe. For the 140 mg dose you must inject the contents of either one 140 mg single-use syringe or two 70 mg single-use syringes, one after the other.

(A)

Remove Aimovig pre-filled syringe(s) from the carton by holding it/them at the barrel. You may need to use either one or two syringes based on your prescribed dose. Do not shake.

To avoid discomfort at the site of injection, leave the syringe(s) at room temperature for at least 30 minutes before injecting.

Note: Do not try to warm the syringe(s) by using a heat source such as hot water or microwave.

(B)

Inspect the syringe(s). Make sure the solution you see in the syringe is clear and colourless to light yellow.

Note:

• – Do not use the syringe if any part of it appears cracked or broken.

• – Do not use the syringe if it has been dropped.

• – Do not use the syringe if the needle cap is missing or is not securely attached.

In all cases described above, use a new syringe, and if you are unsure contact your doctor or pharmacist.

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Gather all materials needed for the injections:

Wash your hands thoroughly with soap and water.

On a clean, well-lit work surface, place the:

• – New syringe(s)

• – Alcohol wipes

• – Cotton balls or gauze pads

• – Adhesive plasters

• – Sharps disposal container

(D)

Prepare and clean the injection site(s).

Upper arm

Stomach area (abdomen)

Thigh

Only use the following injection sites:

• – Thigh

• – Stomach area (abdomen) (except for a 5 cm area around the navel)

• – Outer area of upper arm (only if someone else is giving you the injection)

Clean the injection site with an alcohol wipe and let the skin dry.

Choose a different site each time you give yourself an injection. If you need to use the same injection site, just make sure it is not the same spot on that site you used last time.

Note:

• – After you have cleaned the area, do not touch it again before injecting.

• – Do not choose an area where the skin is tender, bruised, red, or hard. Avoid injecting into areas

with scars or stretch marks.

Step 2: Get ready

(E)

Pull the grey needle cap straight off and away from your body, only when you are ready to inject. The injection must be administered within 5 minutes. It is normal to see a drop of liquid at the end of the needle.

Do not leave the grey needle cap off for more than 5 minutes. This can dry out the medicine.

Do not twist or bend the grey needle cap.

Do not put the grey needle cap back onto the syringe once it has been removed.

(F)

Firmly pinch the skin at the injection site.

Note: Keep skin pinched while injecting.

Step 3: Inject

(G)

While pinching, insert the syringe needle into the skin at an angle of 45 to 90 degrees.

Do not place your finger on the plunger while inserting the needle.

(H)

Using slow and constant pressure, push the plunger rod all the way down until it stops moving.

(I)

When done, release your thumb, and gently lift the syringe off of the skin and then release the pinched skin.

Note: When you remove the syringe, if it looks like there is still medicine in the syringe barrel this means you have not received a full dose. Contact your doctor.

Step 4: Finish (J)

Discard the used syringe and the grey needle cap.

Put the used syringe in a sharps disposal container immediately after use. Talk to your doctor or pharmacist about proper disposal. There may be local regulations for disposal.

Note:

• – Do not reuse the syringe.

• – Do not recycle the syringe or sharps disposal container.