InfoCons Consumer Protection informs you – Aimovig – Package Leaflet

Before anything else

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.

ℹ️ 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.

55 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 ha ve 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 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 pens.

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.

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

Aimovig pens are for single use only.

For detailed instructions on how to inject Aimovig, see “Instructions for use of Aimovig pre -filled pen” 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.

Not known (frequency cannot be estimated from the available data)

• 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 Appendix V . 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 pen(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 pen contains 70 mg erenumab.
• Aimovig 140 mg solution for injection in pre -filled pen 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.

Aimovig is available in packs containing one single -use pre -filled pen and in multipacks containing 3 (3×1) pre-filled pens .

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland

Manufacturer

Sandoz GmbH Biochemiestrasse 10 6336 Langkampfen Austria Novartis Pharma GmbH Roonstrasse 25 90429 Nuremberg Germany Novartis Pharmaceutical Manufacturing GmbH Biochemiestrasse 10 6336 Langkampfen Austria 58 Novartis Pharma GmbH Sophie -Germain -Strasse 10 90443 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 България Novartis Bulgaria EOOD Тел: +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 Ελλάδα Novartis (Hellas) A.E.B.E.

Τηλ: +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 59 Italia Novartis Farma S.p.A.

Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200 Κύπρος Novartis Pharma Services Inc.

Τηλ: +357 22 690 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 00 Latvija SIA Novartis Baltics Tel: +371 67 887 070

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu 60 Instructions for use of Aimovig pre -filled pen s Illustration of the Aimovig 70 mg pen (with light blue body, purple start button, white cap and green safety guard) Before use After use Note: Needle is inside the green safety guard .

Purple start button Expiry date Window Solution White cap on Expiry date Yellow window (injection complete) Green safety guard (needle inside) White cap off Green safety guard (needle inside) 61 Illustration of the Aimovig 140 mg pen ( with dark blue body, grey start button, orange cap and yellow safety guard) Before use After use Note: Needle is inside the yellow safety guard .

Expiry date Window Solution Orange cap on Expiry date Yellow window (injection complete) Yellow safety guard (needle inside) Orange cap off Grey start button Yellow safety guard (needle inside) 62 General Before you use the Aimovig pre -filled pen, read this 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 pen. For the 140 mg dose you must inject the contents of either one 140 mg single -use pen or two 70 mg single -use pens, one after the other. (A) Carefully lift Aimovig pre -filled pen (s) out of the carton. You may need to use either one or two pens based on your prescribed dose. Do not shake.

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

Note: Do not try to warm the pen(s) by using a heat source such as hot water or microwave. (B) Inspect the pen(s). Make sure the solution you see in the window is clear and colourless to light yellow.

Note:

• Do not use the pen (s) if any part appears cracked or broken.
• Do not use any pen that has been dropped.
• Do not use the pen if the cap is missing or is not securely attached.

In all cases described above, use a new pen, and if you are unsure contact your doctor or pharmacist. (C) Gather all materials needed for the injection (s).

Wash your hands thoroughly with soap and water.

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

• New pen (s)
• Alcohol wipe (s)
• Cotton ball (s) or gauze pad(s)
• Adhesive plaster (s)
• Sharps disposal container 63 (D) Prepare and clean the injection site(s).

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 cap straight off, 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 or safety guard.

Note:

• Do not leave the cap off for more than 5 minutes. This can dry out the medicine.
• Do not twist or bend the cap.
• Do not put the cap back onto the pen once it has been removed.
• Do not put your fingers into the safety guard.

Upper arm Stomach area (abdomen) Thigh 64 (F) Create a firm surface at the selected injection site (thigh, stomach, or outer areas of the upper arm), by using either the Stretch method or the Pinch method .

Stretch method Stretch skin firmly by moving your thumb and fingers in opposite directions, creating an area about five cm wide.

Pinch method Pinch skin firmly between your thumb and fingers, creating an area about five cm wide.

Note: It is important to k eep skin stretched or pinched while injecting.

65 Step 3: Inject (G) Keep holding the stretch ed/pinch ed skin . With the cap off, put the safety guard of the pen on the skin at an angle of 90 degrees. The needle is inside the safety guard.

Note: Do not touch the start button yet.

Safety guard (needle inside) 66 (H) Firmly push the pen down onto the skin until it stops moving.

Note: You must push all the way down but do not touch the start button until you are ready to inject. (I) Press the start button. You will hear a click. click Push down 67 (J) Remove your thumb from the button, but keep pushing down on the skin. The injection could take about 15 seconds.

15 seconds Note: When the injection is completed, the window will turn from clear to yellow and you may hear a second click.

Note:

• After you remove the pen from the skin, the needle will automatically be covered by the safety guard.
• When you remove the pen, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means you have not received a full dose. Contact your doctor immediately. click 68 Step 4: Finish (K) Discard the used pen and the cap.

Put the used pen 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 pen.
• Do not recycle the pen or sharps disposal container.
• Always keep the sharps disposal container out of the reach of children.

(L) Examine the injection site.

If there is any blood on the skin, press a cotton ball or gauze pad onto the injection site. Do not rub the injection site. Apply an adhesive plaster if needed.

If your dose is 140 mg and you are using two Aimovig 70 mg pens , repeat steps 1(D) to 4 with the second pen to inject the full dose.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Aimovig (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/18/1293).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.