Aimovig 70 mg solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aimovig 70 mg solution for injection in pre-filled pen

Aimovig 140 mg solution for injection in pre-filled pen

erenumab

Please read all of this 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

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 associated with 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 at the start of treatment with Aimovig.

2. What you need to know before using Aimovig

Do not use Aimovig

• if you are allergic to erenumab or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before starting to use Aimovig:

• if you have ever had an allergic reaction to rubber latex. The container of this medicine contains rubber latex in the cap.
• if you have a cardiovascular disease. Aimovig has not been studied in patients with certain cardiovascular diseases.

Talk to your doctor or seek immediate medical help:

• if you experience any symptoms of a severe allergic reaction, such as rash or swelling, usually of the face, mouth, tongue, or throat; or difficulty breathing. Severe allergic reactions may occur within minutes after using Aimovig, but some may occur more than one week later.
  • contact your doctor if you have constipation, and seek immediate medical help if you develop constipation accompanied by severe or persistent abdominal pain and vomiting, abdominal distension or swelling. Constipation may occur during treatment with Aimovig, usually mild or moderate in severity. However, some patients using Aimovig have developed constipation with serious complications and required hospitalization. Some cases have required surgical intervention.

Children and adolescents

This medicine must not be given to children or adolescents (under 18 years of age) as Aimovig has not been studied in this age group.

Other medicines and Aimovig

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Pregnancy

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

Breastfeeding

Monoclonal antibodies such as Aimovig are known to pass into breast milk during the first few days after birth. However, after this initial period, Aimovig may be used. Consult your doctor about using Aimovig during breastfeeding to help decide whether you should discontinue breastfeeding or stop using Aimovig.

Driving and using machines

It is unlikely that Aimovig will affect your ability to drive or operate machinery.

Aimovig contains sodium

Aimovig contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

3. How to use Aimovig

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

If your doctor prescribes the 70 mg dose, you should administer one injection every 4 weeks. If your doctor prescribes the 140 mg dose, you should administer one injection of Aimovig 140 mg or two consecutive injections of Aimovig 70 mg, once every 4 weeks. If two injections of Aimovig 70 mg are administered, the second injection should be given immediately after the first, at a different injection site. Make sure to inject the entire contents of both pens.

Aimovig is administered as an injection under the skin (i.e., a subcutaneous injection). You or your caregiver may administer the injection in the abdomen or thigh. The outer area of the upper arm may also be used as an injection site, but only if another person administers the injection. If you need two injections, they should be given at different sites to avoid skin hardening and should not be administered in areas where the skin is tender, damaged, red, or hardened.

Your doctor or nurse will train you or your caregiver on the correct way to prepare and inject Aimovig. Do not attempt to administer Aimovig until you have received this training.

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

Aimovig pens are for single use only.

You can find detailed instructions on how to administer Aimovig in the section “Instructions for use of the Aimovig prefilled 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 was administered earlier than it should have been, inform your doctor.

If you forget to use Aimovig

• If you miss a dose of Aimovig, you should administer it as soon as possible after realizing.
• Then contact your doctor, who will tell you when the next dose should be administered. Follow the new schedule exactly as instructed by your doctor.

If you stop using Aimovig

Do not stop treatment with Aimovig without first talking to your doctor. If you stop treatment, your symptoms may return.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following are possible adverse effects. Most of these effects are mild to moderate in nature.

Frequent: may affect up to 1 in 10 patients

• allergic reactions such as rash, swelling, urticaria, or breathing difficulty (see section 2)
• constipation
• itching
• muscle spasms
• reactions at the injection site, such as pain, redness, and swelling at the site where the injection is administered.

Frequency not known (cannot be estimated from available data)

• skin reactions such as rash, itching, hair loss, or mouth or lip sores.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 after EXP and on the carton after CAD. The expiry date refers to the last day of the month indicated.

Store the pen(s) in the outer packaging to protect them from light. Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.

Once Aimovig has been removed from the refrigerator, it should be stored at room temperature (up to 25 °C) within the outer packaging and must be used within a maximum of 7 days; otherwise, it must be discarded. Once Aimovig has been removed from the refrigerator, it must not be returned to it.

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

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of any unused medicines and their packaging. Local regulations for disposal may apply. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aimovig

• The active substance is erenumab.
• Aimovig 70 mg solution for injection in a pre-filled pen contains 70 mg of erenumab.
• Aimovig 140 mg solution for injection in a pre-filled pen contains 140 mg of erenumab.
• The other components are sucrose, polysorbate 80, sodium hydroxide, glacial acetic acid, water for injections.

Nature and contents of the container

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

Aimovig is available in packs containing one single-use pre-filled pen and in multiple packs containing 3 (3x1) pre-filled pens.

Only certain 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

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgium/Belgium/Belgium Novartis Pharma N.V. Tel/Tel: +32 2 246 16 11	Lithuania SIA Novartis Baltics Lithuania branch Tel: +370 5 269 16 50
Bulgaria Novartis Bulgaria EOOD Tel: +359 2 489 98 28	Luxembourg/Luxembourg Novartis Pharma N.V. Tel/Tel: +32 2 246 16 11
Czech Republic Novartis s.r.o. Tel: +420 225 775 111	Hungary Novartis Hungária Kft. Tel.: +36 1 457 65 00
Denmark Novartis Healthcare A/S Tlf: +45 39 16 84 00	Malta Novartis Pharma Services Inc. Tel: +356 2122 2872
Germany Novartis Pharma GmbH Tel: +49 911 273 0	Netherlands Novartis Pharma B.V. Tel: +31 88 04 52 111
Estonia SIA Novartis Baltics Estonia branch Tel: +372 66 30 810	Norway Novartis Norge AS Tlf: +47 23 05 20 00
Greece Novartis (Hellas) A.E.B.E. Tel: +30 210 281 17 12	Austria Novartis Pharma GmbH Tel: +43 1 86 6570
Spain Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00	Poland 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
Croatia Novartis Hrvatska d.o.o. Tel. +385 1 6274 220	Romania Novartis Pharma Services Romania SRL Tel: +40 21 31299 01
Ireland Novartis Ireland Limited Tel: +353 1 260 12 55	Slovenia Novartis Pharma Services Inc. Tel: +386 1 300 75 50
Iceland Vistor hf. Tel: +354 535 7000	Slovakia Novartis Slovakia s.r.o. Tel: +421 2 5542 5439
Italy Novartis Farma S.p.A. Tel: +39 02 96 54 1	Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200
Cyprus Novartis Pharma Services Inc. Tel: +357 22 690 690	Sweden Novartis Sverige AB Tel: +46 8 732 32 00
Latvia SIA Novartis Baltics Tel: +371 67 887 070	United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698370

Date of the most recent review of this leaflet:

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 of Aimovig pre-filled pens

Diagram of the Aimovig 70 mg pen (with light blue body, purple start button, white cap, and green safety guard)

Diagram of the Aimovig 140 mg pen (with dark blue body, grey start button, orange cap, and yellow safety guard)

Step 1: Preparation

Note: Your 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 single-use 70 mg pen. For the 140 mg dose, you must inject the contents of one single-use 140 mg pen or two single-use 70 mg pens consecutively.

(A)

Carefully remove the pre-filled pen(s) of Aimovig from the carton. Depending on your prescribed dose, you may need to use one or two pens. Do not shake.

To help minimize discomfort at the injection site, allow the pen(s) to reach room temperature for at least 30 minutes before injection.

Note: Do not attempt to heat the pen(s) using a heat source such as hot water or a microwave.

(B)

Visually inspect the pen(s). Ensure that the solution seen through the viewing window is clear, colourless, or pale yellow.

Notes:

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

In all cases described above, use a new pen and, if in doubt, contact your doctor or pharmacist.

(C)

Gather all the necessary material for the injection(s). Wash your hands thoroughly with soap and water. On a clean, well-lit work surface, place the following: New pen(s) Alcohol wipe(s) Cotton ball(s) or gauze pad(s) Adhesive bandage(s) (Band-Aid®) Sharps disposal container

(D)

Prepare and clean the injection site(s).

Use only the following injection sites:

• Thigh
• Abdominal area (abdomen) (except for a 5-centimeter area around the navel)
• Outer area of the upper arm (only if someone else is administering the injection)

Clean the injection site with an alcohol swab and allow the skin to dry.

Choose a different spot each time you give an injection. If you need to use the same injection site, make sure it is not the exact same spot used previously.

Note:

• After cleaning the area, do not touch it again before the injection.
• Do not select an area where the skin is tender, damaged, red, or hardened. Avoid injecting into areas with scars or stretch marks.

Step 2: Prepare

(E)

Only when you are ready to inject (not before), remove the cap by pulling it straight off. From this moment, the injection must be administered within a maximum of 5 minutes. It is normal to see a drop of liquid at the needle tip or on the safety shield.

Note:

• Do not leave the cap off for longer than 5 minutes, as the medication could dry out.
• Do not twist or bend the cap.
• Do not reattach the cap to the pen after removing it.
• Do not place your fingers inside the safety shield.

(F)

Prepare a firm surface at the chosen injection site (thigh, abdomen, or outer area of the upper arm) using either the Stretch Method or the Pinch Method.

Stretch Method

Firmly stretch the skin by pulling the thumb and other fingers in opposite directions to create an area approximately five centimeters wide.

Pinch Method

Firmly pinch the skin between the thumb and other fingers to create an area approximately five centimeters wide.

Note: It is important to keep the skin stretched or pinched during injection.

Step 3: Injection

(G)

Keep the skin stretched/pinched. With the cap removed, place the pen’s safety shield against the skin at a 90-degree angle. The needle is located inside the safety shield.

Note: Do not press the start button yet.

(H)

Press the pen firmly against the skin until it can go no further.

Note: Press firmly, but do not press the start button until you are ready to inject.

(I)

Press the start button. You will hear a "click."

(J)

Lift your thumb from the button, but keep the pen pressed against the skin. The injection may take about 15 seconds.

Note: When the injection is complete, the viewing window will change from clear to yellow, and you will hear a second "click."

Note:

• When you lift the pen from the skin, the needle will be automatically covered by the safety shield.
• If, upon removing the pen, the window has not turned yellow or if it appears that medication is still being injected, this means you have not received a full dose. Contact your doctor immediately.

Step 4: Finish

(K)

Dispose of the used pen and cap.

Place the used pen into a sharps disposal container immediately after use. Consult your doctor or pharmacist for proper disposal methods. Local regulations may apply.

Note:

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

(L)

Examine the injection site.

If there is any blood on the skin, press a cotton ball or gauze pad against the injection site. Do not rub the injection site. If needed, apply a bandage.

If you have been prescribed a 140 mg dose and are using two Aimovig 70 mg pens, repeat steps from 1(D) to 4 with the second pen to administer the complete dose.