Novartis

Solution for injection in a pre-filled pen 70 mg 
(The solution is clear to opalescent, colorless to pale yellow.)

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Aimovig is and what it is used for 
2. What you need to know before you use Aimovig 
3. How to use Aimovig 
4. Possible side effects 
5. How to store Aimovig 
6. Contents of the packaging 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 drugs called monoclonal antibodies.

Aimovig works by blocking the activity of the CGRP molecule, which is linked to migraines (CGRP stands for calcitonin-related peptide ).

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

2. What you need to know before using 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 cautions

Talk to your doctor before using Aimovig:

  • if you have ever had an allergic reaction to latex (natural rubber). The needle cover of the container for this medicine contains latex.
  • if you suffer from cardiovascular disease. Aimovig has not been studied in patients with certain cardiovascular diseases.

Contact your doctor or seek immediate emergency medical attention:

  • if you get any symptoms of a severe allergic reaction, e.g. rash or swelling usually of the face, mouth, tongue or throat, or difficulty breathing. Severe allergic reactions may occur within minutes, but may also occur more than one week after using Aimovig.
  • consult a doctor if you become constipated and seek medical attention immediately if you develop constipation with severe or constant abdominal pain (abdominal pain) and vomiting, abdominal swelling, or bloating. Constipation may occur during treatment with Aimovig. It is usually mild or moderate in intensity . However, some patients using Aimovig have had constipation with serious complications and have been hospitalized. Some cases have required surgery.

Children and young people

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

Other drugs and Aimovig

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

Pregnancy and breastfeeding

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 if you should stop using Aimovig during pregnancy.

Breast-feeding

It is known that monoclonal antibodies such as Aimovig pass into breast milk during the first days after birth, but after this first period, Aimovig can be used. Talk to your doctor for advice if you either need to stop breast-feeding or stop using Aimovig during breast-feeding.

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 sodium (23 mg) per dose, ie essentially ‘sodium-free’.

3. How to use Aimovig

Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.

If you have not had any effect of the treatment after 3 months, tell your doctor who will then decide if you should continue with the treatment.

Use Aimovig exactly as your doctor has told you. If your doctor prescribes a 70 mg dose, you should inject once every 4 weeks. If the doctor prescribes the dose of one 140 mg should either take an injection of Aimovig 140 mg or two injections you Aimovig 70 mg once every 4 weeks. If you are taking two injections of Aimovig 70 mg, the second injection must be given immediately after the first but at a different injection site. Be sure to inject the entire contents of both pens

Aimovig is given as an injection under the skin (a so-called subcutaneous injection ). You or someone else can give you an injection in your stomach or thigh. The outside of the upper arm can also be used as an injection site but only if someone else gives you an injection. If you need 2 injections, they should be given in different places to avoid hardening of the skin. Do not give an injection in areas where the skin is tender, red or hard, or has bruises.

Your doctor or nurse will show you or your companion how to prepare and inject Aimovig. Do not try to inject Aimovig until you have received this training.

The Aimovig pens are for single use only.

Detailed instructions on how to inject Aimovig can be found in the “Instructions for use of Aimovig pre-filled pen” section at the end of this leaflet.

If you use more Aimovig than you should  

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

If you forget to use Aimovig

  • If you forget to take a dose of Aimovig, take it as soon as possible when you forget you forgot it.
  • Then contact your doctor, who will tell you when to take the next dose. Follow the new instructions exactly as your doctor has told you

If you stop using Aimovig

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

If you have any further questions on the use of this product, 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 e.g. rash, swelling, hives, or difficulty breathing (see section 2)
  • constipation
  • itching
  • muscle cramps
  • injection site reactions, e.g. pain, redness, and swelling where the injection is given

Aimovig can cause skin reactions e.g. rash or itching.

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

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 expiration date is the last day of the specified month.

Keep the pen (s) in the outer carton. Sensitive to light. Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.

Once removed from the refrigerator, Aimovig must be stored at room temperature (maximum 25 ° C) in the outer carton and used within 14 days. Otherwise, it must be discarded. Do not put Aimovig back in the refrigerator after removing it.

Do not use this medicine if the solution contains particles, is cloudy or clear yellow.

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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

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

What the medicine looks like and the contents of the pack

Aimovig solution for injection is clear to shimmering, colorless to pale yellow, and practically free of particles.

Aimovig is available in a pack of a pre-filled pen for single-use and in a multi-pack 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 Long-distance fighting

Austria

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50
BulgariaNovartis Bulgaria EOODTel: +359 2 489 98 28 Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11
Czech RepublicNovartis sroTel: +420 225 775 111 HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00
DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872
GermanyNovartis Pharma GmbHTel: +49 911 273 0 The NetherlandsNovartis Pharma BVTel: +31 88 04 52 111
EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 NorwayNovartis Norge ASTel: +47 23 05 20 00
GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 AustriaNovartis Pharma GmbHTel: +43 1 86 6570
SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888
FranceNovartis Pharma SASTel: +33 1 55 47 66 00 PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600
CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01
IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439
ItalyNovartis Farma SpATel: +39 02 96 54 1 Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200
ΚύπροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690
LatviaSIA Novartis BalticsTel: +371 67 887 070 United KingdomNovartis Pharmaceuticals UK Ltd.Tel: +44 1276 698370

This leaflet was last modified on 25/08/2020

Other sources of information

Further information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

The following information is intended for healthcare professionals only:

Instructions for use for Aimovig pre-filled pens

Picture of the pen for Aimovig 70 mg

Picture of the pen for Aimovig 140 mg

GenerallyRead this information before using the Aimovig pre-filled pen:

Step 1: Preparation
Note! The prescribed dose of Aimovig is either 70 mg or 140 mg. The dose of one 70 mg means you have to inject the contents of a 70 mg pen for single use. For a 140 mg dose, you will need to inject the contents of either a 140 mg pen or two disposable 70 mg pens, the first one and then the other.

(A)Carefully remove the Aimovig pre-filled pen / pre-filled pens from the carton. You will need to use either one or two pencils depending on the dose prescribed for you. Do not shake the pen (s).
Leave the pen (s) at room temperature for at least 30 minutes before injecting one to reduce discomfort at the injection site.
Note! Do not try to heat the pen / pens with any type of heat source, e.g. hot water or microwave.

(B)Inspect the pen (s). Check that the solution visible in the window is clear and colorless or pale yellow.
Note!Do not use the pen (s) if any part appears cracked or broken.Do not use a pen that has been dropped.Do not use the pen if the needle guard is missing or not attached properly.
If any of the above apply to you, use a new pen . Contact your doctor or pharmacist if you are not sure.

(C)
Bring out everything you need for the injection (s).
Wash your hands thoroughly with soap and water.
Choose a well-lit place and a clean surface and place there: New pen / new pensAlcohol dryer (s)Cotton swab (s) or compress (s)Band-AidContainer for hazardous waste

(D)Prepare and wash the injection site
Use only the following injection sites:ThighStomach (abdomen) (however at least 5 cm from the navel)Outside of the upper arm (only applies if someone else gives you an injection )Wash the injection site with an alcohol swab and allow the skin to dry.
Choose different places each time you give yourself an injection . If you have to use the same injection site, make sure that it is not exactly the same site within the area that you used last time.
Note!After washing the injection site, do not touch it again until you inject one.Do not choose an area with bruises or where the skin is sore, red or hard, or has bruises. Do not inject into areas with scars or stretch marks.

Step 2: Get ready

(E)Pull the needle cover straight off the pen, but not until you are ready to inject one. Injection must be given within 5 minutes . It is normal to see a drop of liquid in the tip of the needle or on the safety guard.
Note!Do not leave the needle cover off for more than 5 minutes. The drug may evaporate.The needle guard should not be twisted or bent.Do not put the needle cover back on the pen once you have removed it.Do not put your fingers in the safety guard.

(F)Create a solid surface at the selected injection site (thigh, abdomen or outside of the upper arm) by either using the Stretch or Pinch method.
Stretch out Extend the skin properly by moving the thumb and other fingers apart so you get an area about five cm wide.
Pinch together take a firm pinch around the skin between the thumb and fingers so you get an area about five cm wide.
Note! It is important to keep the skin stretched or pinched while giving the injection.

Step 3: Inject

(G)Continue to keep the skin stretched / pinched. With the needle cover removed, place the safety pen of the pen against the skin at a 90-degree angle. The needle is inside the safety guard.
Note! Do not touch the start button yet.

(HRS)Press the pen firmly against the skin until it stops.
Note! You must push all the way down but do not touch the start button until you are ready to inject one.

(IN)Press the start button. A click is heard.

(J)Lift the thumb from the button but continue to press down on the skin. Injection can take about 15 seconds.
Note! When injection one is complete, the window will turn yellow (from having previously been completed) and you may hear another click.
Note!When you remove the pen from the skin, the needle is automatically covered by the safety guard.If the window has not turned yellow or if it looks as if the medicine is still being injected when you remove the pen, it means that you have not received the full dose . Contact your doctor immediately.

Step 4: Finish

(K)
Discard the used pen and needle guard. Place the used pen in a hazardous waste container immediately after use. Talk to your doctor or pharmacist about how to dispose of the pen. There may be local regulations on waste management.
Note! The pen must not be reused. The pen or container for hazardous waste must not be left for recycling and must not be disposed of with household waste. Always keep the container for hazardous waste out of the reach of children.

(L)
Examine the injection site. If there is some blood on the skin, press a cotton swab or compress against the injection site. Do not rub at the injection site. Apply a patch if needed.

If your dose is 140 mg and you are taking two Aimovig 70 mg pencils, repeat steps 1 (D) to 4 with the other pen to inject the full dose one.

Muhammad Nadeem

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