Aimovig 140 mg soluciÓn inyectable en pluma precargada

Prospect: information for the user

Aimovig 70 mg injectable solution in pre-filled pen

Aimovig 140 mg injectable solution in pre-filled pen

erenumab

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

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

Aimovig acts by blocking the activity of the CGRP molecule, which has been linked to migraine (CGRP are the English initials 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.

No use Aimovig

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

Warnings and precautions

Consult your doctor before starting to use Aimovig:

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

Consult your doctor or seek immediate medical help:

-if you have any symptoms of a severe allergic reaction, such as rash or inflammation typically of the face, mouth, tongue, or throat; or difficulty breathing. Severe allergic reactions can occur within minutes of using Aimovig, but some may occur more than a week after.

• contact your doctor if you have constipation and seek immediate medical help if you develop severe and persistent abdominal pain or vomiting, abdominal inflammation or swelling. Constipation may occur with Aimovig treatment. It is usually mild or moderate in intensity. However, some patients who have used Aimovig have had severe constipation that required hospitalization.Some cases have required surgical intervention.

Children and adolescents

This medication should not be administered to children or adolescents (under 18 years) as it has not been studied in this age group.

Other medications and Aimovig

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 or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

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. Consult your doctor about using Aimovig during breastfeeding to help you decide whether to stop breastfeeding or stop using Aimovig.

Driving and operating machinery

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

Aimovig contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

If your doctor prescribes a dose of 70 mg, you should administer one injection every 4 weeks. If your doctor prescribes a dose of 140 mg, you should administer 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 a subcutaneous injection under the skin. You or your caregiver can administer the injection in the abdomen or thigh. The outer area 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 how to properly prepare and administer 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 to continue treatment.

Aimovig pens are for single use only.

You can consult the detailed instructions on how to administer Aimovig in the "Aimovig Pre-Filled Pen User Instructions" section 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 earlier than it should have been, inform your doctor.

If you forget to use Aimovig

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

If you interrupt treatment with Aimovig

Do not interrupt treatment with Aimovig without first speaking with your doctor. If you interrupt treatment, your symptoms may reappear.

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 may 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 difficulty breathing (see section2)
• Constipation
• Itching
• Muscle spasms
• Reactions at the injection site, such as pain, redness, and swelling at the site where the injection is administered.

Unknown frequency (cannot be estimated from available data)

-Skin reactions such as rash, itching, hair loss, or sores in the mouth or lip.

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 the label after EXP and on the box after CAD. The expiration date is the last day of the month indicated.

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

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

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

Medicines should not be thrown away through drains. Ask your pharmacist how to dispose of the containers and medications that you no longer need. There may be local regulations for disposal. By doing so, you will help protect the environment.

Composition of Aimovig

• The active ingredient is erenumab.
• Aimovig 70 mg pre-filled syringe contains 70 mg of erenumab.
• Aimovig 140 mg pre-filled syringe contains 140 mg of erenumab.
• The other components are sucrose, polysorbate 80, sodium hydroxide, glacial acetic acid, and water for injection.

Appearance of the product and contents of the pack

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

Aimovig is available in packs containing a pre-filled syringe for single use and in multiple packs containing 3 (3x1) pre-filled syringes.

Only some pack sizes may be marketed.

Marketing authorisation holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer responsible

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 about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of this leaflet:

Other sources of information

Further information about this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu

Instructions for use of Aimovig pre-filled syringes

Scheme of the Aimovig 70 mg syringe(with a blue clear body, violet start button, white cap and green safety guard)

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

Step 1: Preparation

Nota: The dose of Aimovig prescribed to you is either 70 mg or 140 mg. This means that for a dose of 70 mg, you need to inject the contents of a single-use 70 mg syringe. For a dose of 140 mg, you need to inject the contents of a single-use 140 mg syringe or two single-use 70 mg syringes consecutively.

(A)

Remove the pre-filled syringe(s) from the pack. Depending on the dose prescribed to you, you may need to use one or two syringes. Do not shake.

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

Nota: Do not try to heat the syringe using a heat source such as hot water or a microwave.

(B)

Visually inspect the syringe(s). Make sure the solution you see through the window is transparent and colourless or pale yellow.

Nota:

• Do not use the syringe if any component is cracked or broken.
• Do not use any syringe that has fallen.
• Do not use the syringe if the cap is missing or not securely attached.

Use a new syringe in all the above cases and if you have any doubts, contact your doctor or pharmacist.

(C)

(D)

Prepare and clean the injection site(s).

Only use the following injection sites:

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

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

Choose a different site each time you need an injection. If you need to use the same site, make sure it is not the same spot as the previous injection.

Nota:

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

Step 2: Prepare

(E)

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

Nota:

• Do not leave the cap out for more than 5 minutes, as the medicine may dry out.
• Do not turn or bend the cap.
• Do not put the cap back on the syringe after removing it.
• Do not put your fingers inside the safety guard.

(F)

Prepare a firm surfaceat the chosen injection site (thigh, abdomen or outer area of the upper arm), usingeitherthe Stretching methodorthe Pinch method.

Stretching method

Stretch the skin firmly by moving your thumb and other fingers in opposite directions to define an area ofabout 5 centimeterswide.

Pinch method

Pinch the skin firmly between your thumb and other fingers to define an area ofabout 5 centimeterswide.

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

Step 3: Injection

(G)

Keep the skin stretched/pinched. Having removed the cap, placethe safety guard of the syringe on the skin at a 90-degree angle.The needle is inside the safety guard.

Nota: You have not yet touched the start button.

(H)

Press the syringe firmly onto the skin until it will not advance any further.

Nota: You must press as much as possible but do not touch the start button until you are ready to inject.

(I)

Press the start button. You will hear a “click”.

(J)

Release the start button, but keep the syringe pressed onto the skin. The injection may take about 15 seconds.

Nota: When the injection is finished, the window will change from transparent to yellow and you may hear a second “click”.

Nota:

• When you remove the syringe from the skin, the needle will be automatically covered by the safety guard.
• If, when removing the syringe, the window is not yellow or appears to be still injecting medicine, this means you have not received a full dose. Contact your doctor immediately.

Step 4: Final

(K)

Dispose of the used syringe and cap.

Deposit the used syringe in a sharps container immediately after use. Consult your doctor or pharmacist about the correct disposal. There may be local regulations.

Nota:

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

(L)

Examine the injection site.

If there is blood on the skin, press a cotton ball or gauze onto the injection site. Do not rub the injection site. If necessary, apply a band-aid.