Ajovy - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

AJOVY 225 mg solution for injection in pre-filled syringe

fremanezumab

This medicine is subject to additional monitoring. This will allow quick identification of new safetyinformation. You canhelp by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet. See section 4.

What is in 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 AJOVY is and what it is used for

What AJOVY is

AJOVY is a medicine containing the active substance fremanezumab, a monoclonal antibody, a type of protein that recognises and attaches to a specific target in the body.

How AJOVY works

A substance in the body called calcitonin gene-related peptide (CGRP) plays an important role in migraine. Fremanezumab attaches to CGRP and prevents it from working.This reduction in CGRP's activity reduces migraine attacks.

What AJOVY is used for

AJOVY is used to prevent migraine in adults who have at least 4 migraine days per month.

What are the benefits of using AJOVY

AJOVY reduces the frequency of migraine attacks and days with headache.This medicine also decreases the disability associated with migraine and it reduces the need for medicines used to treat migraine attacks.

2. What you need to know before you use AJOVY

Do not use AJOVY

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse if you get any symptoms of an allergic reaction, e.g. trouble breathing, swelling of the lips and tongue, or severe rash, after injecting AJOVY.

Tell your doctor if you have or have had cardiovascular disease (problems affecting 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 children and adolescents below the age of 18 years because it has not been studied in this age group.

Other medicines and AJOVY

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, 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 in pregnant women are not known.

If you are breast-feeding or are planning to breast-feed, talk to your doctor or pharmacist before using this medicine. You and your doctor should decide if you will use AJOVY while breast-feeding.

Driving and using machines

This medicine is not expected to have any effect on your ability to drive or use machines.

AJOVY contains sodium

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

3. How to use AJOVY

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

AJOVY is given by injection under your skin (subcutaneous injection). Your doctor or nurse will explain to you or your caregiver how to give the injection. Do not inject AJOVY until you or your caregiver have been trained by your doctor or nurse.

Read the “Instructions for Use” for 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 recommended dosing options:

• – one injection (225 mg) once a month (monthly dosing) or

• – three injections (675 mg) every 3 months (quarterly dosing)

If your dose is 675 mg, inject the three injections one after another, each in a different place.

Use a reminder method such as notes in a calendar or diary to help you remember your next dose so that you do not miss a dose or have a dose too soon after the last one.

If you use more AJOVY than you should

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

If you forget or miss to use AJOVY

If you have missed a dose of AJOVY, inject your missed dose as soon as you can. Do not take a double dose to make up for a forgotten dose. If you are not sure when to inject AJOVY, talk to your doctor, pharmacist or nurse.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following mild to moderate, short-lasting skin reactions around the injection area can 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 at the injection site

Uncommon (may affect up to 1 in 100 people)

Rash at the injection site

Allergic reactions such as rash, swelling or hives (see section 2)

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. Y ou can also report side effects directly via the national reporting system listed in 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 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 may be removed from the refrigerator and stored at a temperature up to 30 °C for a maximum period of up to 7 days. The medicine must be discarded if it has been out of the refrigerator for longer than 7 days. Once stored at room temperature, do not place back in 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, discoloured, or contains particles.

The syringe is for single use only.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack 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, disodium ethylenediami­netetraacetic acid (EDTA) dihydrate, polysorbate 80 and water for injections.

What AJOVY looks like and contents of the pack

AJOVY is a solution for injection (injection) in a pre-filled syringe with a fixed injection needle in a blister. AJOVY is a clear, colourless to slightly yellow solution. Each pre-filled syringe contains 1.5 mL 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

The Netherlands

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

Belgie/Belgiqu­e/Belgien

Teva Pharma Belgium N.V./S.A./AG

Tél/Tel: +32 3 820 73 73

Efcnrapua

Aktobuc EAfl

Ten.: + 359 2 489 95 85

Česká republika

Teva Pharmaceuticals CR, s.r.o.

Tel: +420 251 007 111

Danmark Teva Denmark A/S Tlf: +45 44 98 55 11	Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 207 540 7117
Deutschland TEVA GmbH Tel: +49 731 402 08	Nederland Teva Nederland B.V. Tel: +31 800 022 8400
Eesti UAB Teva Baltics Eesti filiaal Tel: +372 661 0801	Norge Teva Norway AS Tlf: +47 66 77 55 90
EXÀàôa Specifar A.B.E.E. Tql: +30 211 880 5000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97 007 0
España Teva Pharma, S.L.U. Tél: +34 91 387 32 80	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel.: +48 22 345 93 00
France Teva Santé Tél: +33 1 55 91 78 00	Portugal Teva Pharma – Produtos Farmacéuticos, Lda Tel: +351 21 476 75 50
Hrvatska Pliva Hrvatska d.o.o. Tel: +385 1 37 20 000	Romania Teva Pharmaceuticals S.R.L. Tel: +40 21 230 65 24
Ireland Teva Pharmaceuticals Ireland Tel: +44 207 540 7117	Slovenija Pliva Ljubljana d.o.o. Tel: +386 1 58 90 390
Ísland Teva Pharma Iceland ehf. Sími: +354 550 3300	Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 2 57 26 79 11
Italia Teva Italia S.r.l. Tel: +39 02 89 17 98 1	Suomi/Finland Teva Finland Oy Puh/Tel: +358 20 180 5900
Kùnpoç Specifar A.B.E.E. EUáSa	Sverige Teva Sweden AB Tel: +46 42 12 11 00

Tql: +30 211 880 5000

Latvija UAB Teva Baltics filiale Latvijä Tel: +371 673 23 666

United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 207 540 7117

This leaflet was last revised in {month YYYY }.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

Instructions for Use

AJOVY 225 mg solution for injection in pre-filled syringe fremanezumab

Before you use the AJOVY pre-filled syringe, read and carefully follow the step-by-step instructions.

Important information:

• The AJOVY pre-filled syringe is for single use only.
• Each AJOVY pre-filled syringe contains 225 mg of fremanezumab. Depending on your dose you will need to use 1 pre-filled syringe or 3 pre-filled syringes.
• AJOVY is injected under your skin (subcutaneous injection).You should not inject yourself until you have been trained by your doctor or nurse.
• Carefully read the AJOVY package leaflet to learn more about your medicine.
• Do not pull back on the plunger at any time as this can break the pre-filled syringe.
• Do not shake the pre-filled syringe.
• Put the carton back in the refrigerator immediately, if you have any unused pre-filled

syringes in the carton.

Parts of the AJOVY pre-filled syringe

Step 1: Getting ready for an injection

• a) Gather the following supplies for your injection:

• – 1 or 3 AJOVY pre-filled syringes to enable 1 or 3 injections depending on your dose

• – 1 alcohol swab per injection

• – 1 gauze pad or cotton ball per injection

• – 1 sharps disposal or puncture-resistant container

• b) Place the supplies you have gathered on a clean, flat surface.

• c) Wait for 30 minutes to let AJOVY reach room temperature to reduce discomfort during injection.

• - Do not leave the pre-filled syringe in direct sunlight.

• - Do not warm up the pre-filled syringe using a microwave or any other heat source.

• - Do not remove needle cap.

• d) Wash your hands with soap and water and dry well with a clean towel.

• e) Inspect your AJOVY pre-filled syringe.

• – Check the syringe label. Make sure the name AJOVY appears on the label.

• – Check that the medicine inside the syringe looks clear and is colourless to slightly yellow.

• – You may see small air bubbles in the pre-filled syringe. This is normal.

• - Do not use the pre-filled syringe if you see any of the following:

• ■ The syringe looks damaged.

• ■ The expiration date has passed or the pre-filled syringe has been out of the refrigerator for longer than 7 days.

• ■ The medicine is cloudy, discoloured, or contains particles.

  
  

• f) Choose your injection area.

• – Choose an injection area from the following areas:

• ■ Your stomach area (abdomen), avoid about 5 cm around the belly button

• ■ The front of your thighs , about 5 cm above the knee and 5 cm below the

groin

• ■ The back of your upper arms , in the fleshy areas of the upper back portion

• – If multiple injections are required, they may be given in the same or different area (abdomen, thigh, upper arm), but you should avoid injecting in exactly the same place.

• g) Clean your injection area.

• – Clean the chosen injection area using a new alcohol swab.

• – Wait 10 seconds to allow the skin to dry before injecting.

• - Do not inject AJOVY into an area that is tender, red, hot, bruised, hardened, tattooed

or that has scars or stretch marks.

Step 2: How to inject

• a) Only when you are ready to inject, pull the needle cap straight off and throw it away.

• - Do not put the needle cap back on the pre-filled syringe, to avoid injury and infection.

• - Do not touch the needle.

  ■I--

  
  

  Do not put the needle cap back on the pre-filled syringe.

  
  

b) Inject by following the 4 steps below.

1. Gently pinch up at least 2.5 cm of the skin that you have cleaned.	2. Insert the needle into the pinched skin at a 45° to 90° angle.	3. Slowly push the plunger in.	4. Push the plunger all the way down as far as it will go to inject all of the medicine.
	90' : (//		zgA—'
		-jig
	AV

• c) Remove the needle from your skin.

• – After you have injected all of the medicine, pull the needle straight out.

• - Do not put the cap back on the needle at any time to avoid injury and infection.

• d) Apply pressure at the injection site.

• – Use a clean, dry cotton ball, or gauze to gently press on the injection site for a few seconds.

– Do not rub the injection site or re-use the pre-filled syringe.

Step 3: Disposal of the pre-filled syringe

• a) Dispose of your pre-filled syringe right away.

• – Put your used pre-filled syringes (with the needle still attached) in a sharps disposal container right away after use.

• - Do not throw away (dispose of) loose needles, syringes, or pre-filled syringes with your household waste.

• - Do not recycle used sharps disposal container.

• b) Ask your doctor, pharmacist or nurse how to throw away the container.

If your dose is 675 mg, repeat steps 1 e) to 3 a) with the second and third pre-filled syringe to inject the full dose.

Package leaflet: Information for the patient

AJOVY 225 mg solution for injection in pre-filled pen

fremanezumab

This medicine is subject to additional monitoring. This will allow quick identification of new safetyinformation. You canhelp by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet. See section 4.

What is in 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 AJOVY is and what it is used for

What AJOVY is

AJOVY is a medicine containing the active substance fremanezumab, a monoclonal antibody, a type of protein that recognises and attaches to a specific target in the body.

How AJOVY works

A substance in the body called calcitonin gene-related peptide (CGRP) plays an important role in migraine. Fremanezumab attaches to CGRP and prevents it from working.This reduction in CGRP's activity reduces migraine attacks.

What AJOVY is used for

AJOVY is used to prevent migraine in adults who have at least 4 migraine days per month.

What are the benefits of using AJOVY

AJOVY reduces the frequency of migraine attacks and days with headache.This medicine also decreases the disability associated with migraine and it reduces the need for medicines used to treat migraine attacks.

2. What you need to know before you use AJOVY

Do not use AJOVY

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse if you get any symptoms of an allergic reaction, e.g. trouble breathing, swelling of the lips and tongue, or severe rash, after injecting AJOVY.

Tell your doctor if you have or have had cardiovascular disease (problems affecting 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 children and adolescents below the age of 18 years because it has not been studied in this age group.

Other medicines and AJOVY

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, 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 in pregnant women are not known.

If you are breast-feeding or are planning to breast-feed, talk to your doctor or pharmacist before using this medicine. You and your doctor should decide if you will use AJOVY while breast-feeding.

Driving and using machines

This medicine is not expected to have any effect on your ability to drive or use machines.

AJOVY contains sodium

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

3. How to use AJOVY

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

AJOVY is given by injection under your skin (subcutaneous injection). Your doctor or nurse will explain to you or your caregiver how to give the injection. Do not inject AJOVY until you or your caregiver have been trained by your doctor or nurse.

Read the “Instructions for Use” for 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 recommended dosing options:

• – one injection (225 mg) once a month (monthly dosing) or

• – three injections (675 mg) every 3 months (quarterly dosing)

If your dose is 675 mg, inject the three injections one after another, each in a different place.

Use a reminder method such as notes in a calendar or diary to help you remember your next dose so that you do not miss a dose or have a dose too soon after the last one.

If you use more AJOVY than you should

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

If you forget or miss to use AJOVY

If you have missed a dose of AJOVY, inject your missed dose as soon as you can. Do not take a double dose to make up for a forgotten dose. If you are not sure when to inject AJOVY, talk to your doctor, pharmacist or nurse.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following mild to moderate, short-lasting skin reactions around the injection area can 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 at the injection site

Uncommon (may affect up to 1 in 100 people)

Rash at the injection site

Allergic reactions such as rash, swelling or hives (see section 2)

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. Y ou can also report side effects directly via the national reporting system listed in 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 may be removed from the refrigerator and stored at a temperature up to 30 °C for a maximum period of up to 7 days. The medicine must be discarded if it has been out of the refrigerator for longer than 7 days. Once stored at room temperature, do not place back in 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, discoloured, or contains particles.

The pen is for single use only.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures 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, disodium ethylenediami­netetraacetic acid (EDTA) dihydrate, polysorbate 80 and water for injections.

What AJOVY looks like and contents of the pack

AJOVY is a solution for injection (injection) in a single-dose pre-filled pen. AJOVY is a clear, colourless to slightly yellow solution. Each pre-filled pen contains 1.5 mL 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

The Netherlands

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

Belgie/Belgiqu­e/Belgien

Teva Pharma Belgium N.V./S.A./AG

Tél/Tel: +32 3 820 73 73

Efcnrapua

Aktobuc EAfl

Ten.: + 359 2 489 95 85

Česká republika

Teva Pharmaceuticals CR, s.r.o.

Tel: +420 251 007 111

Danmark Teva Denmark A/S Tlf: +45 44 98 55 11	Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 207 540 7117
Deutschland TEVA GmbH Tel: +49 731 402 08	Nederland Teva Nederland B.V. Tel: +31 800 022 8400
Eesti UAB Teva Baltics Eesti filiaal Tel: +372 661 0801	Norge Teva Norway AS Tlf: +47 66 77 55 90
EXÀàôa Specifar A.B.E.E. Tql: +30 211 880 5000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97 007 0
España Teva Pharma, S.L.U. Tél: +34 91 387 32 80	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel.: +48 22 345 93 00
France Teva Santé Tél: +33 1 55 91 78 00	Portugal Teva Pharma – Produtos Farmacéuticos, Lda Tel: +351 21 476 75 50
Hrvatska Pliva Hrvatska d.o.o. Tel: +385 1 37 20 000	Romania Teva Pharmaceuticals S.R.L. Tel: +40 21 230 65 24
Ireland Teva Pharmaceuticals Ireland Tel: +44 207 540 7117	Slovenija Pliva Ljubljana d.o.o. Tel: +386 1 58 90 390
Ísland Teva Pharma Iceland ehf. Sími: +354 550 3300	Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 2 57 26 79 11
Italia Teva Italia S.r.l. Tel: +39 02 89 17 98 1	Suomi/Finland Teva Finland Oy Puh/Tel: +358 20 180 5900
Kùnpoç Specifar A.B.E.E. EUáSa	Sverige Teva Sweden AB Tel: +46 42 12 11 00

Tql: +30 211 880 5000

Latvija UAB Teva Baltics filiale Latvijä Tel: +371 673 23 666

United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 207 540 7117

This leaflet was last revised in {month YYYY }.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

Instructions for Use

AJOVY 225 mg solution for injection in pre-filled pen fremanezumab

Before you use the AJOVY pre-filled pen, read and carefully follow the step-by-step instructions.

Important information:

• The AJOVY pre-filled pen is for single use only.
• Each AJOVY pre-filled pen contains 225 mg of fremanezumab. Depending on your dose you will need to use 1 pre-filled pen or 3 pre-filled pens.
• AJOVY is injected under your skin (subcutaneous injection). You should not inject yourself until you have been trained by your doctor or nurse.
• Carefully read the AJOVY package leaflet to learn more about your medicine.
• Do not shake the pre-filled pen.
• Put the carton back in the refrigerator immediately, if you have any unused pre-filled pens in the carton.

AJOVY pre-filled pen (before use)

AJOVY pre-filled pen (after use)

• The blue plunger moves down the viewing window during the injection. The blue plunger fills the window when the injection is complete. (Note: When the blue plunger has filled the viewing window you will still be able to see the grey stopper.)
• When injecting AJOVY, hold the pre-filled pen so that your hand does not cover the viewing window.

Step 1: Getting ready for an injection

• a) Gather the following supplies for your injection:

• – 1 or 3 AJOVY pre-filled pens to enable 1 or 3 injections depending on your dose

• – 1 alcohol swab per injection

• – 1 gauze pad or cotton ball per injection

• – 1 sharps disposal or puncture-resistant container

• b) Place the supplies you have gathered on a clean, flat surface.

• c) Wait for 30 minutes to let AJOVY reach room temperature (<30 °C) to reduce discomfort during injection.

• - Do not leave the pre-filled pen in direct sunlight.

• - Do not warm up the pre-filled pen using a microwave or any other heat source.

• d) Wash your hands with soap and water and dry well with a clean towel.

• e) Inspect your AJOVY pre-filled pen.

• – Check the pen label. Make sure the name AJOVY appears on the label.

• – Check that the medicine in the pen viewing window looks clear and is colourless to slightly yellow.

• – You may see small air bubbles in the pre-filled pen. This is normal.

• - Do not use the pre-filled pen if you see any of the following:

• ■ The pen looks damaged.

• ■ The expiration date has passed or the pre-filled pen has been out of the refrigerator for longer than 7 days.

• ■ The medicine is cloudy, discoloured, or contains particles.

• f) Choose your injection area.

• – Choose an injection area from the following areas:

• ■ Your stomach area (abdomen), avoid about 5 cm around the belly button

• ■ The front of your thighs , about 5 cm above the knee and 5 cm below the groin

• ■ The back of your upper arms , in the fleshy areas of the upper back portion

– If multiple injections are required, they may be given in the same or different area (abdomen, thigh, upper arm), but you should avoid injecting in exactly the same place.

• g) Clean your injection area.

• – Clean the chosen injection area using a new alcohol swab.

• – Wait 10 seconds to allow the skin to dry before injecting.

• - Do not inject AJOVY into an area that is tender, red, hot, bruised, hardened, tattooed or that has scars or stretch marks.

Step 2: How to inject

• a) Remove the protective cap and do not replace.

• – Pull the protective cap straight off. Do not twist.

• - Do not put the protective cap back on the pre-filled pen, to avoid injury and infection.

• - Do not touch the needle shield area.

• b) Inject by following the steps below.

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

• – Press down on the pre-filled pen and keep pressed down against the skin for about 30 seconds. Do not remove pressure until the 3 steps below are complete.

  • 1. You hear the first “click” (this signals the start of the injection and the blue plunger starts to move).

• 2. You hear a second “click” (about 15 seconds after the first “click”; the plunger will be moving to the bottom of the viewing window as the medicine is being injected).

• c) Check that the blue plunger has filled the viewing window and remove the pre-filled pen from your skin.

• – After you have injected all of the medicine, i.e. the blue plunger has filled the viewing window and you are able to see the grey stopper, remove the pre-filled pen from the skin by lifting the pre-filled pen straight up and dispose straightaway into a sharp disposal container (see step 3).

• – As the pre-filled pen is lifted from the skin, the needle shield returns to the original position and locks into place, covering the needle.

• - Do not put the protective cap back on the pre-filled pen at any time to avoid injury and infection.

  
  

• d) Apply pressure at the injection site.

• – Use a clean, dry cotton ball, or gauze to gently press on the injection site for a few seconds.

• - Do not rub the injection site or re-use the pre-filled pen.

Step 3: Disposal of the pre-filled pen

• a) Dispose of your pre-filled pen right away.

• – Put your used pre-filled pens in a sharps disposal container right away after use.

• - Do not throw away (dispose of) pre-filled pens with your household waste.

• - Do not recycle used sharps disposal container.

• b) Ask your doctor, pharmacist or nurse how to throw away the container.