Ajovy

Package leaflet: Information for the patient

AJOVY 225 mg solution for injection in pre-filled syringe

fremanezumab
Please read all of this leaflet carefully before you use this medicine because 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 other people, even if they have the same symptoms as yours, because it may be harmful.
• If you get any side effects, including those not listed in this leaflet, talk to 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 using 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, that is
a type of protein that recognises a specific target in the body and binds to it.
How AJOVY works
A substance in the body called calcitonin gene-related peptide (CGRP) plays an important role in migraine.
Fremanezumab binds to CGRP, preventing it from working. Reducing CGRP activity reduces migraine attacks.
What AJOVY is used for
AJOVY is used for the prevention of migraine in adults who have at least 4 migraine days per month.
What benefits of using AJOVY
AJOVY reduces the frequency of migraine attacks and the number of headache days. This medicine also
reduces migraine-related disability and the need for medications to treat migraine attacks.

2. What you should 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 an AJOVY injection. These reactions may occur within 24 hours after using AJOVY, but sometimes they may be delayed.
Inform your doctor if you have or have had cardiovascular disease (heart and blood vessel problems)
before using this medicine, as 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor
or pharmacist before taking this medicine. It is preferable to avoid using AJOVY during
pregnancy, as the effects of this medicine in pregnant women are unknown.
If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before using this medicine. You and your doctor will decide whether AJOVY should be used during
breastfeeding.
Driving and using machines
This medicine is not expected to affect your ability to drive vehicles or operate machinery.
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 exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Read carefully the “Instructions for use” of the pre-filled syringe before using AJOVY.
Dose and timing of injection
Your doctor will discuss and decide with you the most appropriate dosing schedule. There are two
recommended alternative dosing options:

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

If you are to self-inject the 675 mg dose, administer the three injections consecutively at three different
injection sites.
AJOVY is administered by injection under the skin (subcutaneous injection). Your doctor or
nurse will explain to you or to the person assisting you how to perform the injection. Do not inject
AJOVY yourself until you or the person assisting you has been trained by a doctor or nurse.
Use a reminder method, such as calendar notes or a diary, to help you remember when your next dose is due, so that you do not 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 administer a
double dose to make up for the 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 everyone experiences 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)
Rash at the injection site
Allergic reactions, such as rash, swelling, or hives

Rare (may affect up to 1 in 1,000 people)
Severe allergic reactions (symptoms may include difficulty breathing, swelling of the lips and tongue, or severe rash) (see section 2 “Warnings and precautions”).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via 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 AJOVY

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the syringe 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 kept 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 if the medicine is cloudy, discoloured or contains particles.
The syringe is for single use only.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in 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 monohydrochloride monohydrate, sucrose, ethylenediaminetetraacetic acid (EDTA) disodium dihydrate, polysorbate 80, and water for injections.

Description of the appearance of AJOVY and contents of the pack
AJOVY is an injectable solution (injection preparation) contained 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 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
For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:
België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203
България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл.: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373
Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel.: +36 12886400
Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf.: +45 44985511 Ireland
Tel: +44 2075407117
Deutschland Nederland
Teva Nederland B.V.
TEVA GmbH Tel: +31 8000228400
Tel: +49 73140208
Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590
Ελλάδα Österreich
TEVA HELLAS Α.Ε. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070
España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel.: +48 223459300
France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550
Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524
Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390
Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911
Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900
Κύπρος Sverige
TEVA HELLAS Α.Ε. Teva Sweden AB
Greece Tel: +46 42121100
Τηλ: +30 2118805000
Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .

---

Instructions for use
AJOVY 225 mg solution for injection in pre-filled syringe
fremanezumab
Before using the AJOVY pre-filled syringe, read and carefully follow the detailed instructions below.
Important information:

• Read the AJOVY patient information leaflet carefully to learn more about the medicine.
• Do not pull back the plunger at any time, as the pre-filled syringe may break.
• Do not shake the pre-filled syringe.
• If the box contains unused pre-filled syringes, return them immediately to the refrigerator.

Parts of the AJOVY pre-filled syringe

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

• 1 or 3 AJOVY pre-filled syringes, depending on the dose required (for 1 or 3 injections)
• 1 alcohol swab for each injection
• 1 gauze pad or cotton ball for each injection
• 1 sharps container or puncture-resistant container for safe disposal
  b) Place the items you have gathered on a clean, flat surface.
  c) Wait 30 minutes to allow AJOVY to reach room temperature to reduce discomfort during injection.
• Do not leave the pre-filled syringe in direct sunlight.
• Do not heat the pre-filled syringe in a microwave or with other heat sources.
• Do not remove the needle cap.
  d) Wash your hands thoroughly with soap and water, then 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 colourless to slightly yellow.
• Small air bubbles may be present in the pre-filled syringe. This is normal.
• Do not use the pre-filled syringe if:
• The syringe appears damaged.
• The expiry 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 colour, or contains particles.

f) Choose the injection site.

• Select an injection site from the following areas:
• The abdominal area (abdomen), avoiding the 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 upper arms, in the fleshy part of the upper back
• If multiple injections are needed, they may be administered in the same area or in different areas (abdomen, thigh, arm), but avoid using 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.
• Do not inject AJOVY into an area that is painful, red, warm, bruised, hardened, tattooed, scarred, or has stretch marks.

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

• Do not recap the needle onto the pre-filled syringe to avoid injury and infection.
• Do not touch the needle.

b) Administer the injection by following these 4 steps.

c) Remove the needle from the skin.

• After injecting all the medicine, pull the needle straight out.
• Never replace the cap onto 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 several minutes.
• Do not rub the injection site or reuse the pre-filled syringe.

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

• Immediately after use, place used pre-filled syringes (with the needle still attached) into a sharps disposal container.
• Do not throw loose needles, syringes, or pre-filled syringes into household waste.
• Do not recycle used sharps disposal containers. b) Ask your doctor, pharmacist, or nurse how to dispose of the container.

If you need to self-inject the 675 mg dose, 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
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 using 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, which is
a type of protein that recognises a specific target in the body and binds to it.
How AJOVY works
A substance in the body called calcitonin gene-related peptide (CGRP) plays an important role in migraine.
Fremanezumab binds to CGRP, preventing it from acting. By reducing CGRP activity, AJOVY reduces migraine attacks.
What AJOVY is used for
AJOVY is used for the prevention of migraine in adults who have at least 4 migraine days per month.
What benefits of using AJOVY can be expected
AJOVY reduces the frequency of migraine attacks and the number of headache days. This medicine also
reduces migraine-related disability and the need for medications to treat migraine attacks.

2. What you should 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 injection of AJOVY. These reactions may occur within 24 hours after using AJOVY, but sometimes
they may be delayed.
Inform 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, think you might be pregnant, or are planning to become pregnant, consult your
doctor or pharmacist before taking this medicine. It is preferable to avoid using AJOVY during
pregnancy, because the effects of this medicine in pregnant women are unknown.
If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before using
this medicine. You and your doctor will decide whether to use AJOVY during breastfeeding.
Driving and using machines
This medicine is not expected to affect your ability to drive or use machinery.
AJOVY contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".

3. How to use AJOVY

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

Dose and timing of injection
Your doctor will discuss and decide with you the most appropriate dosing schedule. There are two recommended alternative dosing options:

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

If you need to self-administer the 675 mg dose, perform the three injections consecutively at three different injection sites.
AJOVY is administered by injection under the skin (subcutaneous injection). Your doctor or nurse will explain to you or to the person assisting you how to perform the injection. Do not inject AJOVY yourself unless you or the person assisting you has been trained by a doctor or nurse.
Use a reminder method, such as calendar notes or a diary, to help you remember when to take your next dose, so you do not 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, administer the missed dose as soon as possible. Do not take a double dose to make up for the missed dose. If you are unsure about 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 will experience 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)
Rash at the injection site
Allergic reactions, such as rash, swelling, or hives

Rare (may affect up to 1 in 1,000 people)
Severe allergic reactions (symptoms may include difficulty breathing, swelling of the lips and tongue, or severe rash) (see section 2 "Warnings and precautions").

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via 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 stated on the label of the pen 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 of 7 days. The medicine must be discarded if it has been kept 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 if the solution is cloudy, has changed colour, or contains particles.
The pen is for single use only.
Do not dispose of medicines via 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 pen contains 225 mg of fremanezumab.
• The other ingredients (excipients) are L-histidine, L-histidine monohydrochloride monohydrate, sucrose, ethylenediaminetetraacetic acid (EDTA) disodium dihydrate, polysorbate 80, and water for injections.

Description of the appearance of AJOVY and contents of the pack
AJOVY is an injectable solution (injection preparation) contained in a single-dose pre-filled pen.
AJOVY is a clear, colourless to slightly yellow solution. 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл.: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel.: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf.: +45 44985511 L-Irlanda
Tel: +44 2075407117

Deutschland Nederland
TEVA GmbH Teva Nederland B.V.
Tel: +49 73140208 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
TEVA HELLAS Α.Ε. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel.: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
TEVA HELLAS Α.Ε. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

---

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

Before using the AJOVY pre-filled pen, read and carefully follow the detailed instructions below.

Important information:

• Read the AJOVY package leaflet carefully to learn more about the medicine.
• Do not shake the pre-filled pen.
• If the box contains unused pre-filled pens, return them immediately to the refrigerator.

AJOVY pre-filled pen (before use)

AJOVY pre-filled pen (after use)

• During injection, the blue plunger moves along the viewing window until it completely fills the window when the injection is complete. (Note: when the blue plunger completely fills the viewing window, the grey stopper may still be visible.)
• When injecting AJOVY, hold the pre-filled pen so that your hand does not cover the viewing window.

Step 1: Prepare for injection
a) Gather the following items for injection:

• 1 or 3 AJOVY pre-filled pens, depending on the dose required (for 1 or 3 injections)
• 1 alcohol swab for each injection
• 1 gauze pad or cotton ball for each injection
• 1 sharps or puncture-resistant disposal container

b) Place the gathered items on a clean, flat surface.
c) Wait 30 minutes for AJOVY to reach room temperature (<30 °C) to reduce discomfort during injection.

• Do not leave the pre-filled pen in direct sunlight.
• Do not heat the pre-filled pen in a microwave or with other heat sources.
  d) Wash your hands thoroughly with 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 solution 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.
• Do not use the pre-filled pen if:
• The pen appears damaged.
• The expiry date has passed, or the pre-filled pen has been kept outside the refrigerator for more than 7 days.
• The solution is cloudy, has changed colour, or contains particles.

f) Choose the injection site.

• Select an injection site from the following areas:
• The abdominal area (abdomen), avoiding a 5 cm radius around the navel
• The front of the thighs, approximately 5 cm above the knee and 5 cm below the groin
• The back of the upper arms, in the fleshy areas
• If multiple injections are needed, they may be administered in the same area or in different areas (abdomen, thigh, arm), but avoid using the exact same spot.

g) Clean the injection site.

• Clean the selected injection site using a new alcohol swab.
• Wait 10 seconds to allow the skin to dry before administering the injection.
• Do not inject AJOVY into areas that are painful, red, warm, bruised, hardened, tattooed, or have scars or stretch marks.

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

• Remove the protective cap by pulling it off. Do not twist it.
• Do not replace the protective cap on the pre-filled pen to avoid injury and infection.
• Do not touch the needle guard area.

b) Administer the injection by following these steps.

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

• Press the pre-filled pen against the skin and maintain pressure for at least 30 seconds. Do not release pressure until the following three steps are completed.

c) Check that the blue plunger has completely filled the viewing window and remove the
prefilled pen from the skin.

• After injecting the entire medicine, i.e. when the blue plunger has completely filled the viewing window and the grey stopper becomes visible, remove the prefilled pen from the skin by lifting it vertically, and immediately dispose of it in a sharps disposal container (see step 3).
• When the prefilled pen is lifted from the skin, the needle shield automatically returns to its original position and locks, covering the needle.
• Never replace the protective cap onto the prefilled 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 several minutes.
• Do not rub the injection site, and do not reuse the prefilled pen.

Step 3: Disposal of the prefilled pen
a) Dispose of the prefilled pen immediately.
a. Immediately after use, place used prefilled pens in a sharps disposal container.
b. Do not throw away (dispose of) prefilled pens in household waste.
c. Do not recycle used sharps disposal containers.
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
prefilled pens to inject the full dose.