AJOVY 225 mg Roztwór Do Wstrzykiwań

Treść ulotki

1. AJOVY 225 mg injectable solution in pre-filled syringe
   1. What is AJOVY and what is it used for
   2. What you need to know before using AJOVY
   3. How to use AJOVY
   4. Possible side effects
   5. How to store AJOVY
   6. Package Contents and Other Information
2. AJOVY 225 mg injectable solution in pre-filled syringe
3. AJOVY 225 mg solution for injection in pre-filled pen
   1. What is AJOVY and what is it used for
   2. What you need to know before using AJOVY
   3. How to use AJOVY
   4. Possible side effects
   5. How to store AJOVY
   6. Contents of the pack and other information
4. AJOVY 225 mg injectable solution in pre-filled pen

AJOVY 225 mg injectable solution in pre-filled syringe

fremanezumab

Read this leaflet carefully before 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 their symptoms are the same as yours, 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 AJOVY is and what it is used for
• 2. What you need to know before you use AJOVY
• 3. How to use AJOVY
• 4. Possible side effects
• 5. How to store AJOVY
• 6. Contents of the pack and other information

1. What is AJOVY and what is it used for

What is AJOVY
AJOVY is a medicine containing the active substance fremanezumab, a monoclonal antibody, i.e.
a type of protein that recognizes a specific target in the body and binds to it.

How does AJOVY work
A substance present in the body, called calcitonin gene-related peptide (CGRP),
plays an important role in migraine. Fremanezumab binds to CGRP, preventing it from acting. Reducing the
activity of CGRP reduces migraine attacks.

What is AJOVY used for
AJOVY is used for the prevention of migraine in adults who experience at least 4 migraine days
per month.

What are the benefits of using AJOVY
AJOVY reduces the frequency of migraine attacks and headache days. This medicine also reduces
disability associated with migraine and the need for medicines to treat migraine
attacks.

2. What you need to know before using AJOVY

Do not use AJOVY
Do not use this medicine if you are allergic to fremanezumab or to any of the other ingredients of
this medicine (listed in section 6).

Warnings and precautions
Contact your doctor, pharmacist or nurse immediately if you experience signs of a severe
allergic reaction, such as difficulty breathing, swelling of the lips and tongue or severe skin
rash after injecting AJOVY. These reactions may occur within 24 hours of
using AJOVY, but sometimes they may be delayed.
Tell your doctor if you have or have had cardiovascular disease (problems with the heart and blood vessels)
before using this medicine, because AJOVY has not been studied in patients with certain
cardiovascular diseases.

Children and adolescents
AJOVY is not recommended for use in children and adolescents under 18 years of age, as
it has not been studied in this age group.

Other medicines and AJOVY
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 or are planning to become pregnant, ask your doctor
or pharmacist for advice before taking this medicine. It is preferable to avoid the use of AJOVY during
pregnancy, as the effects of this medicine on pregnant women are unknown.
If you are breastfeeding or planning to breastfeed, ask your doctor or pharmacist
before using this medicine. Your doctor will decide with you whether to use AJOVY during
breastfeeding.

Driving and operating machinery
No effects on the ability to drive and operate machinery are expected from this medicine.

AJOVY contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium-free”.

3. How to use AJOVY

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
Read the “Instructions for Use” of the pre-filled syringe carefully before using AJOVY.

How much and when to inject
Your doctor will discuss and decide with you the most appropriate dosing schedule. There are two
alternative dosing options recommended:

• one injection (225 mg) once a month (monthly administration), or
• three injections (675 mg) every 3 months (quarterly administration)

If you need to inject the 675 mg dose, administer the three injections one after the other in three
different injection sites.
AJOVY is administered by injection under the skin (subcutaneous injection). Your doctor or
nurse will explain to you or the person assisting you how to administer the injection. Do not inject
AJOVY before you or the person assisting you has been trained by the doctor or nurse.
Use a method, for example notes on a calendar or diary, as a reminder to help you
remember the next dose so as not to miss a dose or administer a dose too close to the previous one.

If you use more AJOVY than you should
If you have used more AJOVY than you should, inform your doctor.

If you forget to use AJOVY or miss a dose
If you have missed a dose of AJOVY, inject the missed dose as soon as possible. Do not take a
double dose to make up for a missed dose. If you are unsure when to inject AJOVY, consult your
doctor, pharmacist or nurse.
If you have any questions about the use of this medicine, consult 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:
Very common (may affect more than 1 in 10 people)
Pain, hardening or redness at the injection site
Common (may affect up to 1 in 10 people)
Itching sensation at the injection site
Uncommon (may affect up to 1 in 100 people)
Skin rash at the injection site
Allergic reactions, such as skin rash, swelling or hives
Rare (may affect up to 1 in 1,000)
Severe allergic reactions (signs may include difficulty breathing, swelling of the lips
and tongue or severe skin rash) (see section 2 “Warnings and precautions”).

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 detailed in Annex V. By reporting side effects you can help
to provide more information on the safety of this medicine.

5. How to store AJOVY

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 syringe label and on the
outer carton after “EXP”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the pre-filled syringe in the outer carton to protect the medicine from light.
This medicine can be removed from the refrigerator and stored at a maximum temperature of 30 °C
for a maximum period of 7 days. The medicine must be discarded if it has been outside the
refrigerator for more than 7 days. Once stored at room temperature, do not return it to the
refrigerator.
Do not use this medicine if you notice that the outer carton has been tampered with, the syringe is damaged or
the medicine is cloudy, has changed colour or contains particles.
The syringe is for single use only.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What AJOVY contains

• The active substance is fremanezumab. Each pre-filled syringe contains 225 mg of fremanezumab.
• The other ingredients (excipients) are L-histidine, L-histidine hydrochloride monohydrate, sucrose, ethylenediaminetetraacetic acid (EDTA) disodium dihydrate, polysorbate 80 and water for injections.

Description of AJOVY and package contents
AJOVY is an injectable solution (preparation for injection) contained in a pre-filled syringe with
a fixed injection needle in a blister. AJOVY is a clear solution, from colourless to slightly
yellow. Each pre-filled syringe contains 1.5 mL of solution.
AJOVY is available in packs containing 1 or 3 pre-filled syringes. Not all pack sizes may be
available in your country.

Marketing Authorisation Holder
TEVA GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany

Manufacturer
Merckle GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
Teva Pharmaceuticals Europe B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Teл: +359 24899585

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Deutschland
TEVA GmbH
Tel: +49 73140208

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
TEVA HELLAS Α.Ε.
Τηλ: +30 2118805000

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Teva Pharma, S.L.U.
Tel: +34 913873280

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

France
Teva Santé
Tél: +33 155917800

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
TEVA HELLAS Α.Ε.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117

Other sources of information
Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666
More detailed information on this medicine is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .
------------------------------------------------------------------------------------------------------------------------

Instructions for Use

AJOVY 225 mg injectable solution in pre-filled syringe

fremanezumab

Before using the AJOVY pre-filled syringe, read and follow the following detailed instructions carefully.
Important information:

• Do notpull back the plunger at any time as the pre-filled syringe may break.
• Do notshake the pre-filled syringe.
• If the box contains unused pre-filled syringes , immediately return them tothe refrigerator.

Parts of the AJOVY pre-filled syringe

Step 1: Preparing for the injection
a)Gather the following products for the injection:

• 1 or 3 AJOVY pre-filled syringes to administer 1 or 3 injections depending on the dose
• 1 alcohol swab for each injection
• 1 gauze pad or cotton ball for each injection
• 1 sharps container or puncture-resistant container b)Place the products you have gathered on a clean flat surface.c)Wait 30 minutes for AJOVY to reach room temperature in order toreduce discomfort during the injection.
• Do notleave the pre-filled syringe in direct sunlight.
• Do notheat the pre-filled syringe in a microwave or with other heat sources.
• Do notremove the needle cap. d)Wash your handswith soap and water and dry them well with a clean towel. e)Inspect the AJOVY pre-filled syringe.
• Check the syringe label. Make sure the name AJOVY appears on the label.
• Verify that the medicine inside the syringe is clear and colorless to slightly yellow.
• Small air bubbles may be present in the pre-filled syringe. This is normal.
• Do notuse the pre-filled syringe if you notice that:
• The syringe appears damaged.
• The expiration date has passed or the pre-filled syringe has been out of the refrigerator for more than 7 days.
• The medicine is cloudy, has changed color, or contains particles.

f)Choose the injection site.

• Choosethe injection site from:
• The abdominal area(abdomen), avoiding 5 cm around the navel
• The front of the thighs, about 5 cm above the knee and 5 cm below the groin
• The back of the arms, in the fleshy areas of the upper back
• If multiple injections are needed, they can be performed in the same area or in different areas (abdomen, thigh, arm), but avoid the exact same point.

g)Clean the injection site.

• Clean the chosen injection site using a new alcohol swab.
• Wait 10 seconds to allow the skin to dry before administering the injection.
• Do notinject AJOVY into an area that is painful, red, warm, bruised, hardened, with tattoos or scars or stretch marks.

Step 2: How to administer the injection
a)Only when you are ready to administer the injection, remove the needle cap by pulling it
straight off and discard it.

• Do notput the needle cap back on the pre-filled syringe to avoid injury and infection.
• Do nottouch the needle.

b)Administer the injection following these 4 steps.

1. Gently pinch at least 2.5 cm of the cleaned skin.	2. Insert the needle into the pinched skin at an angle between 45° and 90°.	3. Slowly push the plunger.	a m 4. Push the plunger all the way down to inject all of the medicine.
e l F a

c)Remove the needle from the skin.

• After injecting all the medicine, pull the needle straight out.
• Do notput the cap back on the needle, to avoid injury and infection.

d)Apply pressure to the injection site.

• Use a clean, dry cotton ball or gauze pad to gently press on the injection site for a few minutes.
• Do notrub the injection site or reuse the pre-filled syringe.

Step 3: Disposing of the pre-filled syringe
a)Dispose of the pre-filled syringe immediately.

• Immediately after use, place the used pre-filled syringes (with the needle still inserted) in a sharps container.
• Do notdiscard (dispose of) loose needles, syringes, or pre-filled syringes in household waste.
• Do notrecycle the used sharps container. b)Ask your doctor, pharmacist, or nurse how to dispose of the container.

If you need to inject the 675 mg dose, repeat steps 1 e) to 3 a) with the second and third
pre-filled syringes to inject the entire dose.

AJOVY 225 mg solution for injection in pre-filled pen

fremanezumab

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 their symptoms are the same as yours, 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 AJOVY is and what it is used for
• 2. What you need to know before you use AJOVY
• 3. How to use AJOVY
• 4. Possible side effects
• 5. How to store AJOVY
• 6. Contents of the pack and other information

1. What is AJOVY and what is it used for

What is AJOVY
AJOVY is a medicine containing the active substance fremanezumab, a monoclonal antibody, i.e.
a type of protein that recognizes a specific target in the body and binds to it.

How does AJOVY work
A substance present in the body, called calcitonin gene-related peptide (CGRP),
plays an important role in migraine. Fremanezumab binds to CGRP, preventing it from acting. Reducing the
activity of CGRP reduces migraine attacks.

What is AJOVY used for
AJOVY is used for the prevention of migraine in adults who experience at least 4 migraine days
per month.

What are the benefits of using AJOVY
AJOVY reduces the frequency of migraine attacks and headache days. This medicine also reduces
disability associated with migraine and the need for medicines to treat migraine attacks.

2. What you need to know before using AJOVY

Do not use AJOVY
Do not use this medicine if you are allergic to fremanezumab or to any of the other ingredients of
this medicine (listed in section 6).

Warnings and precautions
Contact your doctor, pharmacist or nurse immediately if you experience signs of a severe
allergic reaction, such as difficulty breathing, swelling of the lips and tongue or severe skin
rash after injecting AJOVY. These reactions can occur within 24 hours of
using AJOVY, but can sometimes be delayed.
Tell your doctor if you have or have had cardiovascular disease (heart and blood vessel problems)
before using this medicine, because AJOVY has not been studied in patients with certain
cardiovascular diseases.

Children and adolescents
AJOVY is not recommended for use in children and adolescents under 18 years of age, as
it has not been studied in this age group.

Other medicines and AJOVY
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 or are planning to become pregnant, ask your doctor
or pharmacist for advice before taking this medicine. It is preferable to avoid the use of AJOVY during
pregnancy, as the effects of this medicine on pregnant women are unknown.
If you are breastfeeding or planning to breastfeed, ask your doctor or pharmacist
before using this medicine. You and your doctor will decide together whether to use AJOVY during
breastfeeding.

Driving and operating machinery
No effects on the ability to drive and operate machinery are expected from this medicine.

AJOVY contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium-free”.

3. How to use AJOVY

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
Read the “Instructions for Use” of the pre-filled pen carefully before using AJOVY.

How much and when to inject
Your doctor will discuss and decide with you the most appropriate dosing schedule. There are two
alternative dosing options recommended:

• one injection (225 mg) once a month (monthly administration), or
• three injections (675 mg) every 3 months (quarterly administration)

If you need to inject the 675 mg dose, administer the three injections one after the other in three
different injection sites.
AJOVY is administered by injection under the skin (subcutaneous injection). Your doctor or
nurse will explain to you or the person assisting you how to perform the injection. Do not inject
AJOVY before you or the person assisting you has been trained by the doctor or nurse.
Use a method, for example notes on a calendar or diary, as a reminder to help you
remember the next dose so as not to miss a dose or administer a dose too close to the previous one.

If you use more AJOVY than you should
If you have used more AJOVY than you should, inform your doctor.

If you forget to use AJOVY or miss a dose
If you have missed a dose of AJOVY, inject the missed dose as soon as possible. Do not take a
double dose to make up for a forgotten dose. If you are not sure when to inject AJOVY, consult
your doctor, pharmacist or nurse.
If you have any questions about the use of this medicine, consult 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:
Very common (may affect more than 1 in 10 people)
Pain, hardening or redness at the injection site
Common (may affect up to 1 in 10 people)
Itching sensation at the injection site
Uncommon (may affect up to 1 in 100 people)
Skin rash at the injection site
Allergic reactions, such as skin rash, swelling or hives
Rare (may affect up to 1 in 1,000)
Severe allergic reactions (signs may include difficulty breathing, swelling of the lips
and tongue or severe skin rash) (see section 2 “Warnings and precautions”).

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 listed in Annex V. By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store AJOVY

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 pen label and on the
outer carton after “EXP”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the pre-filled pen in the outer carton to protect the medicine from light.
This medicine can be removed from the refrigerator and stored at a maximum temperature of 30 °C
for a maximum period of 7 days. The medicine must be discarded if it has been outside the
refrigerator for more than 7 days. Once stored at room temperature, do not return it to the
refrigerator.
Do not use this medicine if you notice that the outer carton has been tampered with, the pen is damaged or
the medicine is cloudy, has changed colour or contains particles.
The pen is for single use only.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What AJOVY contains

• The active substance is fremanezumab. Each pre-filled pen contains 225 mg of fremanezumab.
• The other ingredients (excipients) are L-histidine, L-histidine hydrochloride monohydrate, sucrose, ethylenediaminetetraacetic acid (EDTA) disodium dihydrate, polysorbate 80 and water for injections.

Description of AJOVY and contents of the pack
AJOVY is an injectable solution (injectable preparation) contained in a pre-filled pen
single-dose. AJOVY is a clear solution, from colourless to slightly yellow. Each pre-filled pen
contains 1.5 mL of solution.
AJOVY is available in packs containing 1 or 3 pre-filled pens. Not all pack sizes may be
available in your country.

Marketing Authorisation Holder
TEVA GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany

Manufacturer
Merckle GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
Teva Pharmaceuticals Europe B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Teл: +359 24899585

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Deutschland
TEVA GmbH
Tel: +49 73140208

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
TEVA HELLAS Α.Ε.
Τηλ: +30 2118805000

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Teva Pharma, S.L.U.
Tel: +34 913873280

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

France
Teva Santé
Tél: +33 155917800

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
TEVA HELLAS Α.Ε.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117

Other sources of information
Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666
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

AJOVY 225 mg injectable solution in pre-filled pen

fremanezumab

Before using the pre-filled pen of AJOVY, read and follow the following detailed instructions carefully.
Important information:

• Donot shake the pre-filled pen.
• If the box contains unused pre-filled pens , immediately put them back in therefrigerator.

AJOVY pre-filled pen (before use)

AJOVY pre-filled pen (after use)

• During the injection, the blue plunger moves along the viewing window until it completely occupies it when the injection is complete. (Note: when the blue plunger occupies the entire viewing window, you can still see the grey stop).
• When injecting AJOVY, hold the pre-filled pen so that your hand does not cover the viewing window.

Step 1: Preparing for the injection
a)Gather the following products for the injection:

• 1 or 3 pre-filled AJOVY pens to administer 1 or 3 injections depending on the dose
• 1 alcohol swab for each injection
• 1 gauze pad or cotton ball for each injection
• 1 sharps disposal container or puncture-resistant container b)Place the products you have gathered on a clean flat surface.c)Wait 30 minutes for AJOVY to reach room temperature (<30 °C) in orderto reduce discomfort during the injection.
• Donot leave the pre-filled pen in direct sunlight.
• Donot heat the pre-filled pen in a microwave or with other heat sources. d)Wash your handswith soap and water and dry them well with a clean towel. e)Inspect the AJOVY pre-filled pen.
• Check the pen label. Make sure the name AJOVY appears on the label.
• Verify that the medicine inside the pen’s viewing window is clear and colourless to slightly yellow.
• Small air bubbles may be present in the pre-filled pen. This is normal.
• Donot use the pre-filled pen if you notice that:
• The pen appears damaged.
• The expiry date has passed or the pre-filled pen has been left out of the refrigerator for more than 7 days.
• The medicine is cloudy, has changed colour or contains particles.

f)Choose the injection site.

• Choosethe injection site from:
• The abdominal area(stomach), avoiding 5 cm around the navel
• The front of the thighs, about 5 cm above the knee and 5 cm below the groin
• The back of the arms, in the fleshy areas of the upper back
• If multiple injections are needed, they can be made in the same area or in different areas (abdomen, thigh, arm), but avoid the exact same spot.

g)Clean the injection site.

• Clean the chosen injection site using a new alcohol swab.
• Wait 10 seconds to allow the skin to dry before administering the injection.
• Donot inject AJOVY into an area that is painful, red, warm, bruised, hardened, with tattoos or scars or stretch marks.

Step 2: How to administer the injection
a)Remove the protective cap and do not put it back on.

• Remove the protective cap by pulling. Donot rotate it.
• Donot put the protective cap back on the pre-filled pen, to avoid injury and infection.
• Donot touch the needle protection area.

b)Administer the injection by following these steps.

• Place the pre-filled pen at a 90° angle against the skin at the injection site.

• Press on the pre-filled pen and maintain pressure against the skin for at least 30 seconds. Donot remove the pressure until you have completed the following 3 steps.

1. You hear the first "click" (which signals the start of the injection; the blue plunger starts to move).	2. You hear a second "click" (about 15 seconds after the first "click"; the plunger moves towards the bottom of the viewing window as the medicine is injected).	3. Wait another 10 seconds (to ensure that all the medicine has been injected). c a
F a r m

c)Check that the blue plunger occupies the entire viewing window and remove the
pre-filled pen from the skin.

• After injecting all the medicine, i.e. when the blue plunger has completely occupied the viewing window and you can see the grey stop, remove the pre-filled pen from the skin by lifting it vertically and immediately dispose of it in a sharps disposal container (see step 3).
• When the pre-filled pen is lifted from the skin, the needle protection returns to its original position and locks, covering the needle.
• Donot put the protective cap back on the pre-filled pen, to avoid injury and infection.

d)Apply pressure to the injection site.

• Use a clean, dry cotton ball or gauze pad to gently press on the injection site for a few minutes.
• Donot rub the injection site or reuse the pre-filled pen.

Step 3: Disposing of the pre-filled pen
a)Dispose of the pre-filled pen immediately.

• a. Immediately after use, place the used pre-filled pens in a sharps disposal container.

• b. Donot throw (dispose of) the pre-filled pens in household waste.
• c. Donot recycle the used sharps container. b)Ask your doctor, pharmacist or nurse how to dispose of the container.

If you need to inject the 675 mg dose, repeat steps 1 e) to 3 a) with the second and third
pre-filled pens to inject the entire dose.