AIMOVIG 70 mg Injectable Solution

Зміст інструкції

1. Aimovig 70 mg injectable solution in pre-filled syringe, 140 mg injectable solution in pre-filled syringe
   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. How to store Aimovig
   6. Content of the pack and other information
2. Aimovig 70 mg injectable solution in pre-filled pen, 140 mg injectable solution in pre-filled pen
   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. How to store Aimovig
   6. Content of the pack and other information

Aimovig 70 mg injectable solution in pre-filled syringe, 140 mg injectable solution in pre-filled syringe

erenumab

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of 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 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 known as
monoclonal antibodies.
Aimovig works by blocking the activity of the CGRP molecule which has been linked to migraine (CGRP
corresponds to calcitonin gene-related peptide).
Aimovig is used to prevent migraine in adults who have at least 4 migraine days a
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 had an allergic reaction to natural rubber latex. The container of this medicine contains natural rubber latex within the cap.
• if you suffer from cardiovascular disease. Aimovig has not been studied in patients with certain cardiovascular diseases.

Seek medical attention from your doctor or go to the nearest emergency room immediately:

• 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 can occur within minutes, but some may occur more than a week after using Aimovig.
• Contact a doctor if you experience constipation and seek immediate medical attention if you experience constipation with severe or persistent abdominal pain and vomiting, abdominal bloating or flatulence. Constipation may occur if you are treated with Aimovig. It is usually mild to moderate in intensity. However, some patients treated with Aimovig have experienced constipation with serious complications and have been hospitalised. Some cases have required surgery.

Children and adolescents
Do not give this medicine to children or adolescents (under 18 years of age) 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 taking, have recently taken or might take any other
medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding
ask your doctor for advice before taking this medicine.
Pregnancy
Your doctor will decide whether you should stop using Aimovig during pregnancy.
Breastfeeding
It is known that monoclonal antibodies like Aimovig 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 using Aimovig.

Driving and using machines
It is unlikely that Aimovig will affect your ability to drive and use machines.

Aimovig contains sodium
Aimovig contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially “sodium-free”.

3. How to use Aimovig

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor.
If the doctor prescribes a 70 mg dose, you must have one injection every 4 weeks. If the
doctor prescribes a 140 mg dose, you must have one 140 mg injection of Aimovig or two
70 mg injections of Aimovig every 4 weeks. If you are having two 70 mg injections of
Aimovig, the second injection must be given immediately after the first in a different injection
site. Make sure you have injected the entire contents of both syringes.
Aimovig is administered with an injection under the skin (known as a subcutaneous injection). You or the
person assisting you 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 the injection is given to you by
another person. If you need 2 injections, they must be given in different sites to avoid
skin hardening and must not be given in areas where the skin is painful, bruised, reddened or
hardened.
The doctor or nurse will teach you or the person assisting you the correct way to prepare and
inject Aimovig. Do not attempt to inject Aimovig yourself until you have been
taught how to do so.
If you have not observed any effect of the treatment after 3 months, inform your doctor who will decide if you should
continue the treatment.
The Aimovig syringes are for single use only.
For detailed instructions on how to inject Aimovig, see “Instructions for use of Aimovig syringe”

If you use more Aimovig than you should
If you have received more Aimovig than you should or the dose has been administered before it was scheduled,
inform your doctor.

If you forget to use Aimovig

• If you have forgotten to inject a dose of Aimovig, administer it as soon as you remember the omission.
• Then inform your doctor who will tell you when you should inject the next dose. Follow the new schedule exactly as indicated by your doctor.

If you stop using Aimovig
Do not stop using Aimovig without talking to your doctor first. If you stop the treatment, the
symptoms may reappear.
If you have any doubts 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 possible side effects are listed below. The majority of these side effects
are mild to moderate.

Common: may affect up to 1 in 10 people

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

Not known(frequency cannot be estimated from available data)

• Skin reactions such as rash, itching, hair loss or mouth/lip ulcers.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system detailed in Annex 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 the packaging
after EXP/Scad. The expiry date refers to the last day of that month.
Keep the syringe in the outer packaging to protect the medicine from light. Store in
refrigerator (2°C - 8°C). Do not freeze. Do not shake.
After Aimovig has been removed from the refrigerator, it must be kept at room temperature (up to
25°C) in the outer packaging and must be used within 7 days or discarded. Do not put Aimovig back in
the refrigerator once it has been removed.
Do not use this medicine if you observe that the solution contains particles, if it is cloudy or is
clearly yellow.
Do not dispose of any medicine in the drain or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. There may be local regulations for disposal.
This will help to protect the environment.

6. Content of the pack and other information

What Aimovig contains

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

Description of the appearance of Aimovig and contents of the pack
Aimovig solution for injection is a clear to opalescent, colourless to pale yellow liquid and
practically free from particles.
Each pack contains one single-use pre-filled syringe.

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

Manufacturer
Alcon-Couvreur
Rijksweg 14
B-2870 Puurs
Belgium
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
For further information on this medicine, 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

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

United Kingdom (Northern Ireland)
Novartis Ireland Limited
Tel: +44 1276 698370

Other sources of information
More 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 syringe

Syringe image
Before useAfter use

Used plunger
Plunger
Support
flange
Label and expiry
date
Support
flange
Syringe body
Label and expiry used
date
Body
Used needle
Solution
Grey cap
removed
Grey cap
inserted
(needle inside)
Note: The needle is inside the grey cap.

General
Before using the Aimovig pre-filled syringe, read this
important information:
Step 1: Preparation
Note: The prescribed dose of Aimovig is 70 mg or 140 mg. This means that for the 70 mg dose, you must
inject the contents of one 70 mg single-use syringe. For the 140 mg dose, you must inject the
contents of one 140 mg single-use syringe or two 70 mg single-use syringes, one injection
after the other.

• (A)

Remove the Aimovig pre-filled syringe from the box holding the syringe body. You may need to
use one or two syringes depending on the dose you have been prescribed. Do not shake.
To avoid discomfort at the injection site, leave the syringe at room temperature for at least
30 minutes before injection.
Note: Do not try to warm the syringe using a heat source such as hot water or a microwave.

• (B)

Inspect the syringe(s). Make sure the solution you see inside the syringe is
clear and colourless to pale yellow.
Note:

• Do not use the syringe if any part appears cracked or broken.
• Do not use the syringe if it has been dropped.
• Do not use the syringe if the grey cap is missing or is not firmly attached.

In all of the above cases, use a new syringe and, if in doubt, contact your doctor or pharmacist.

• (C)

Prepare all the necessary material
for the injection:
Wash your hands thoroughly with
soap and water.
On a clean and well-lit surface, place:

• New syringe(s)
• Alcohol swabs
• Cotton wool or gauze
• Plasters
• Sharps disposal container

• (D)

Prepare and clean the injection site.

Upper arm
Stomach
area
(abdomen)
Thigh

Only use the following injection sites:

• Thigh
• Stomach area (abdomen) (except for the area 5 cm around the navel)
• Outer area of the arm (only if the injection is performed by another person)

Clean the injection site with an alcohol swab and allow the skin to dry.
Choose a different site each time you give an injection. If you need to use the same
injection site, make sure it is not exactly in the same spot as the site you used last
time.
Note:

• After cleaning the area, do not touch it again before the injection.
• Do not choose an area where the skin is sore, bruised, red or hardened. Avoid injection into areas where there are scars or stretch marks.

Step 2: Immediately before the injection

• (E)

Pull off the grey cap and away from the syringe body, only when you are ready to
give the injection. The injection must be given within 5 minutes. It is normal to see a
drop of liquid come out of the tip of the needle.

Note :

• Do not leave the syringe without the grey cap for more than 5 minutes. This may dry out the medicine.
• Do not twist or bend the grey cap.
• Do not put the grey cap back on the syringe once it has been removed.
• (F)

Form a skin fold by firmly pinching the skin at the injection site.

Note: Keep the skin fold throughout the injection.

Step 3: Injection

• (G)

While maintaining the skin fold, insert the needle of the syringe into the skin at an angle of 45 to 90 degrees.

Do not put your fingers on the plunger during needle insertion.

• (H)

Using slow and steady pressure, push the plunger all the way in until it stops.

• (I)

Once the injection is complete, lift your thumb off the plunger and gently remove the syringe from the skin by lifting
the syringe and then releasing the skin fold.

Note: When removing the syringe, if it appears that there is still medicine in the syringe body,
this means that you have not received a full dose. Contact your doctor.

Step 4: Completion

• (J)

Dispose of the used syringe and grey cap.
Place the used syringe in an appropriate sharps container immediately after use. Talk to your doctor or
pharmacist about proper disposal. There may be local laws for disposal.
Note:

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

• (K)

Examine the injection site.
If there is blood on the skin, press a cotton wool or gauze pad on the injection site. Do not
rub the injection site. Apply a plaster if necessary.

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

Aimovig 70 mg injectable solution in pre-filled pen, 140 mg injectable solution in pre-filled pen

erenumab

Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of 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 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 known as
monoclonal antibodies.
Aimovig works by blocking the activity of the CGRP molecule which has been linked to migraine (CGRP
corresponds to calcitonin gene-related peptide).
Aimovig is used to prevent migraine in adults who have at least 4 migraine days a
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 had an allergic reaction to natural rubber latex. The container of this medicine contains natural rubber latex within the cap.
• if you suffer from cardiovascular disease. Aimovig has not been studied in patients with certain cardiovascular diseases.

Seek medical attention from your doctor or go to the nearest emergency room immediately:

• 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. Serious allergic reactions can occur within minutes, but some can occur more than a week after using Aimovig.
• Contact a doctor if you experience constipation and seek immediate medical attention if you experience constipation with severe or persistent abdominal pain and vomiting, abdominal bloating or flatulence. Constipation may occur if you are treated with Aimovig. It is usually mild to moderate in intensity. However, some patients treated with Aimovig have experienced constipation with serious complications and have been hospitalized. Some cases have required surgery.

Children and adolescents
Do not give this medicine to children or adolescents (under 18 years of age) 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 taking, have recently taken or might take any other
medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding
ask your doctor for advice before taking this medicine.
Pregnancy
Your doctor will decide whether you should stop using Aimovig during pregnancy.
Breastfeeding
It is known that monoclonal antibodies such as Aimovig 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 using Aimovig.

Driving and using machines
It is unlikely that Aimovig will affect your ability to drive and use machines.

Aimovig contains sodium
Aimovig contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially “sodium-free”.

3. How to use Aimovig

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor.
If the doctor prescribes the 70 mg dose, you must have one injection every 4 weeks. If the
doctor prescribes the 140 mg dose, you must have one 140 mg injection of Aimovig or two
70 mg injections of Aimovig every 4 weeks. If you are having two 70 mg injections of
Aimovig, the second injection must be given immediately after the first in a different injection
site. Make sure you have injected the entire contents of both pens.
Aimovig is administered with an injection under the skin (known as a subcutaneous injection). You or the
person assisting you 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 the injection is given to you by another
person. If you need 2 injections, they must be given in different sites to avoid
skin hardening and must not be given in areas where the skin is painful, bruised, reddened or
hardened.
The doctor or nurse will teach you or the person assisting you the correct way to prepare and
inject Aimovig. Do not attempt to inject Aimovig yourself until you have been
taught how to do so.
If you have not noticed any effect of the treatment after 3 months, inform your doctor who will decide if you should
continue the treatment.
The Aimovig pens are for single use only.
For detailed instructions on how to inject Aimovig, see “Instructions for use of Aimovig pen”

If you use more Aimovig than you should
If you have received more Aimovig than you should or the dose has been given earlier than expected,
inform your doctor.

If you forget to use Aimovig

• If you have forgotten to inject a dose of Aimovig, administer it as soon as you remember the omission.
• Then inform your doctor who will tell you when you should inject the next dose. Follow the new schedule exactly as indicated by your doctor.

If you stop using Aimovig
Do not stop using Aimovig without talking to your doctor first. If you stop the treatment, the
symptoms may reappear.
If you have any 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 possible side effects are listed below. The majority of these side effects
are mild to moderate.

Common: may affect up to 1 in 10 people

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

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

• Skin reactions such as rash, itching, hair loss or ulcers in the mouth/lips.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects
you can help to 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 on the packaging
after EXP/Scad. The expiry date refers to the last day of that month.
Keep the pen in the outer packaging to protect the medicine from light. Store in
refrigerator (2°C - 8°C). Do not freeze. Do not shake.
After Aimovig has been removed from the refrigerator, it must be kept at room temperature (up to
25°C) in the outer packaging and must be used within 7 days or discarded. Do not put Aimovig back in
the refrigerator once it has been removed.
Do not use this medicine if you observe that the solution contains particles, if it is cloudy or is
clearly yellow.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. There may be local regulations for disposal.
This will help protect the environment.

6. Content of the pack and other information

What Aimovig contains

• 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.

Description of the appearance of Aimovig and contents of the pack
Aimovig solution for injection is a clear to opalescent, colourless to light yellow liquid and
practically free from particles.
Aimovig is available in packs containing one single-use pre-filled pen and in multi-packs
containing 3 (3x1) 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
For further information on this medicinal product, 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

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

United Kingdom (Northern Ireland)
Novartis Ireland Limited
Tel: +44 1276 698370

Other sources of information
More detailed information on 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 pens

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

Before useAfter use

Start button
purple
Expiry date
Expiry date
Yellow window
Window (injection complete)
Solution
Safety
device green
(needle inside)
Safety device
green
(needle inside)
White cap inserted
White cap removed
Note: The needle is inside the green safety device.

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

Before useAfter use

Start button
grey
Date of
Expiry date
expiry
Yellow window
(injection
complete)
Window
Solution
Yellow safety
device
(needle inside)
Yellow safety
device
(needle inside)
Orange cap inserted
Orange cap
removed
Note: The needle is inside the yellow safety device.

General
Before using the Aimovig pre-filled pen, read
this information.
Step 1: Preparation
Note: The prescribed dose of Aimovig is 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 one 140 mg single-use pen or two 70 mg single-use pens, one injection
after the other.

• (A)

Carefully remove the Aimovig pre-filled pen(s) from the box. You may need to
use one or two pens depending on the dose prescribed for you. Do not shake.
To avoid discomfort at the injection site, leave the pen at room temperature for at least
30 minutes before the injection.
Note: Do not try to warm the pen using a heat source such as hot water or a 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 a pen that has been dropped.
• Do not use the pen if the cap is missing or if it is not firmly attached

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

• (C)

Prepare all the material
necessary for the injection(s).
Wash your hands thoroughly with
soap and water.
On a clean and well-lit surface, place:

• New pen(s)
• Alcohol swab(s)
• Cotton wool or gauze
• Plaster(s)
• Sharps disposal container

• (D)

Prepare and clean the injection site.

Upper arm
Stomach
area
(abdomen)
Thigh

Only use the following injection sites:

• Thigh
• Stomach area (abdomen) (except for the area 5 cm around the navel)
• Outer area of the upper arm (only if the injection is performed by another person)

Clean the injection site with an alcohol swab and allow the skin to dry.
Choose a different site each time you give an injection. If you need to use the same
injection site, make sure it is not in exactly the same spot as the site you used last
time.
Note:

• Do not touch the area again after cleaning it before the injection.
• Do not choose an area where the skin is sore, bruised, red or hardened. Avoid injecting into areas where there are scars or stretch marks.

Step 2: Just before the injection

• (E)

Remove the cap only when you are ready for the injection. The injection must be given

within 5 minutes. It is normal to see a drop of liquid come out of the tip of the needle or the safety device.

Note:

• Do not leave the pen without the cap for more than 5 minutes. This may dry out the medicine.
• Do not twist or bend the cap.
• Do not put the cap back on the pen once it has been removed.
• Do not put your fingers into the safety device.

• (F)

Form a firm surface at the selected injection site (thigh, stomach or outer areas of the
upper arm) using eitherthe distension method orthe skin pinch method.

Distension method
Firmly distend the skin by moving your thumb and other fingers in opposite directions to form
an area approximately fivecm wide.

Skin pinch method
Firmly pinch the skin between your thumb and other fingers to form an area approximately fivecm
wide.

Note: It is important to keep the skin distended or the skin pinch during the injection.

Step 3: Injection

• (G)

Continue to hold the skin distended/maintain the skin pinch throughout the injection. With the
cap removed, place the pen’s safety device on the skin at a 90-degree angle.
The needle is inside the safety device.

Safety device (needle
inside)
Note: Do not press the start button yet.

• (H)

Press the pen firmly against the skin until it stops.

Push down
Note: You must push down all the way but do not touch the start button until
you are ready to give the injection.

• (I)

Pressthe start button. You will hear a click.

• (J)

Remove your thumb from the start button but continue to push down on the skin. The injection may
take about 15 seconds.

15 seconds

Note: When the injection is complete, the window will turn from clear to yellow and you will hear the sound
of a second click.

Note:

• After removing the pen from the skin, the needle will be automatically covered by the safety device.
• When you remove the pen, if the window has not turned yellow or if it looks like the medicine has not been fully injected, this means you have not received the full dose. Contact your doctor immediately.

Step 4: Conclusion

• (K)

Dispose of the used pen and cap.
Place the used pen in a suitable sharps container immediately after
use. Talk to your doctor or pharmacist about proper disposal. There may be local laws
regarding disposal.
Note:

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

• (L)

Examine the injection site.
If there is blood on the skin, press a cotton ball or gauze on the injection site. Do not
rub the injection site. Apply a bandage if necessary.

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