AIMOVIG 70 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN

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

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

1. What is Aimovig and what is it 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 days of migraine per month at the start of 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 you start using Aimovig:

• if you have ever had an allergic reaction to latex. The container of this medicine contains latex rubber 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 have any symptoms of a severe allergic reaction, such as rash or swelling normally of the face, mouth, tongue, or throat; or difficulty breathing. Severe allergic reactions can occur within minutes after using Aimovig, but some may occur more than a week later.
  • contact your doctor if you have constipation and seek immediate medical help if you develop constipation with severe abdominal pain or vomiting, abdominal swelling, or bloating. Constipation may occur with treatment with Aimovig. It is usually mild or moderate. However, some patients who have used Aimovig have had constipation with serious complications and have been hospitalized. Some cases have required surgical intervention.

Children and adolescents

This medicine must not be used in children and adolescents (under 18 years) as it 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 breastfeeding

If you are pregnant or breastfeeding, 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.

Breastfeeding

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

Driving and using machines

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

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 of this medicine given by your doctor. If you are unsure, ask your doctor again.

If your doctor prescribes the 70 mg dose, you should inject one injection every 4 weeks. If your doctor prescribes the 140 mg dose, you should inject one injection of Aimovig 140 mg or two consecutive injections of Aimovig 70 mg, every 4 weeks. If two injections of Aimovig 70 mg are administered, the second injection should be administered immediately after the first, in 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 can administer the injection in the abdomen or thigh. The outer aspect of the upper arm can also be used as an injection site, but only if someone else is administering the injection. If you need 2 injections, they should be administered in different locations to avoid skin hardening and should not be administered in areas where the skin is sensitive, damaged, red, or hardened.

Your doctor or nurse will teach you or your caregiver 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 of the treatment after 3 months, inform your doctor, who will decide whether you should continue treatment.

The Aimovig pens are for single use only.

You can find detailed instructions on how to administer Aimovig in the section “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 administered before it was due, inform your doctor.

If you forget to use Aimovig

• If you forget a dose of Aimovig, you should administer it as soon as possible after you remember.
• Then contact your doctor, who will tell you when to administer the next dose. Follow the new schedule exactly as your doctor tells you.

If you stop using Aimovig

Do not stop using Aimovig without talking to your doctor first. If you stop treatment, your symptoms may come back.

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. Most of these 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 at the injection site.

Frequency not known (cannot be estimated from the available data)

• skin reactions such as rash, itching, hair loss, or ulcers in the mouth or lip.

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 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 is the last day of the month shown.

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) in the outer packaging and used within 7 days, or otherwise discarded. Once Aimovig has been removed from the refrigerator, it must not be put back.

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

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

6. Container Contents and Additional Information

Aimovig Composition

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

Product Appearance and Container Contents

Aimovig injectable solution is transparent to opalescent, colorless to light yellow, and practically free of particles.

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

Only certain package sizes may be marketed.

Marketing Authorization 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medication is available on the European Medicines Agency website: http://www.ema.europa.eu

Instructions for Use of Aimovig Pre-filled Pens

Aimovig 70 mg Pen Scheme(with light blue body, purple start button, white cap, and green safety protector)

Aimovig 140 mg Pen Scheme(with dark blue body, gray start button, orange cap, and yellow safety protector)

Step 1: Preparation

Note: The dose of Aimovig prescribed for you is either 70 mg or 140 mg. This means that for the 70 mg dose, you will inject the contents of one single-use 70 mg pen. For the 140 mg dose, you will inject the contents of one single-use 140 mg pen or two single-use 70 mg pens consecutively.

(A)

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

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

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

(B)

Visually examine the pen(s). Make sure the solution you see through the window is transparent and colorless or light yellow.

Note:

• 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 firmly attached.

In all cases described above, use a new pen, and if you have any doubts, contact your doctor or pharmacist.

(C)

(D)

Prepare and clean the injection site(s).

Use only the following injection sites:

• Thigh
• Abdomen (except for a 5 cm area around the navel)
• Outer aspect of the upper arm (only if someone else is administering the injection)

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

Choose a different site each time you inject. If you need to use the same injection site, make sure it is not the same spot you used last time.

Note:

• After cleaning the site, do not touch it again before injection.
• Do not choose a site where the skin is sensitive, damaged, red, or hardened. Avoid injecting into areas with scars or stretch marks.

Step 2: Prepare

(E)

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

Note:

• Do not leave the cap off for more than 5 minutes, as the medication may dry out.
• Do not twist or bend the cap.
• Do not put the cap back on the pen after it has been removed.
• Do not put your fingers inside the safety protector.

(F)

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

Stretch Method

Stretch the skin firmly by moving your thumb and other fingers in opposite directions to define an area of about 5cm in width.

Pinch Method

Pinch the skin firmly between your thumb and other fingers to define an area of about 5cm in width.

Note: It is essential to keep the skin stretched or pinched while injecting.

Step 3: Injection

(G)

Keep the skin stretched/pinched. After removing the cap, place the safety protector of the pen on the skin at a 90-degree angle. The needle is inside the safety protector.

Note: Do not touch the start button yet.

(H)

Press the pen firmly against the skin until it no longer moves.

Note: You must press firmly but do not touch the start button until you are ready to inject.

(I)

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

(J)

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

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

Note:

• When you lift the pen off the skin, the needle will be automatically covered by the safety protector.
• If, when you remove 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 complete dose. Contact your doctor immediately.

Step 4: Finish

(K)

Discard the used pen and cap.

Place the used pen in a sharps disposal container immediately after use. Consult your doctor or pharmacist about the correct disposal method. There may be local regulations regarding this.

Note:

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

(L)

Examine the injection site.

If there is any bleeding on the skin, press a cotton ball or gauze over the injection site. Do not rub the injection site. If necessary, apply a bandage.