Patient Medication Information: uses, side effects, how to take - Ajovy

What AJOVY is used for:

AJOVY is a prescription medicine used for the prevention of migraine in adults who have at least 4 migraine days per month.
AJOVY is also used for the preventive treatment of episodic migraine (fewer than 15 migraine days per month) in children aged 6 – 17 years and weighing at least 45 kg (99 pounds).

AJOVY has not been studied in children younger than 6 years of age.

AJOVY has not been studied in children with chronic migraine.

How AJOVY works:

AJOVY works by blocking the activity of a molecule called calcitonin gene-related peptide (CGRP). Increased CGRP levels in the blood may cause migraine attacks.

The ingredients in AJOVY are:

Medicinal ingredients: fremanezumab

Non-medicinal ingredients: Disodium ethylenediaminetetraacetic acid dihydrate (EDTA), L-histidine, polysorbate80, sucrose, and water for Injection

AJOVY comes in the following dosage forms:

Subcutaneous injection in a prefilled syringe or a prefilled autoinjector, each containing 225mg/1.5mL(150mg/mL) and each for a single use.

Do not use AJOVY if:

Do not use AJOVY if you are allergic to fremanezumab or any of the ingredients in AJOVY. See the “What are the ingredients of AJOVY” above for a complete list of the ingredients in AJOVY.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AJOVY. Talk about any health conditions or problems you may have, including if you:

If you have severe kidney disease
If you have severe liver disease
are pregnant or plan to become pregnant. It is not known if AJOVY will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if AJOVY passes into your breast milk. Talk to your healthcare professional about the best way to feed your baby while using AJOVY

Talk to your doctor, pharmacist or nurse right away if you get:

Severe injection site reactions such as area of swelling, bleeding
Severe allergic reactions such as trouble breathing, swelling of the lips and tongue, itching or severe rash after injecting AJOVY.
These reactions may occur within minutes, although some may occur up to one month after administration.

Tell your doctor if you have or have had cardiovascular disease (problems with the heart and blood vessels) before using this medication, because AJOVY has not been studied in patients with certain cardiovascular diseases.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

How to take AJOVY:

See the detailed “Instructions for Use” for information on how to prepare and inject a dose of AJOVY.
Use AJOVY exactly as your healthcare professional tells you to use it.
AJOVY is injected under your skin (subcutaneously).
Your healthcare professional should show you or your caregiver how to prepare and inject your first dose of AJOVY. A child 13 years of age and older may give AJOVY themselves under the supervision of an adult or may receive AJOVY by a caregiver. A child younger than 13 years of age will receive AJOVY by a caregiver.
Your healthcare professional will tell you how much AJOVY to use and when to use it. See Usual Dose section for more information.

Adults

Your healthcare professional will tell you if you should use AJOVY 225 mg one time every month or AJOVY 675 mg one time every 3 months.
If your prescribed dose is AJOVY 675 mg every 3 months, you must use 3 separate syringes or 3 separate autoinjectors. You will give 3 separate injections, one after another, one time every 3 months.
If you are giving 3 injections of AJOVY for your prescribed dose, you may use the same body site for all 3 injections. Do NOT use the same spot for all 3 injections
Do not inject AJOVY in the same injection site that you inject other medicine.
If your doctor changes the frequency of injections, the new dose regimen should be given on the next scheduled dosing date of the old dose regimen.

If you have questions about your schedule, ask your healthcare professional.

Children 6 to 17 years of age and weighing and least 45 kg (99 pounds)

Use AJOVY 225 mg one time every month
Do not inject AJOVY in the same injection site that you inject other medicine.

If you have questions about your schedule, ask your healthcare professional.

Usual dose:

AJOVY comes as single-use (1 time) pre-filled syringe or a prefilled autoinjector, each containing a single-dose. Your healthcare professional will prescribe the dose that is best for you.

Adult

If your healthcare professional prescribes the 225 mg monthly dose for you, take 1 injection every month, using a prefilled syringe or a prefilled autoinjector.
Be aware that the monthly dose consists of a single subcutaneous injection.
If your healthcare professional prescribes the 675 mg every 3 months dose for you, take 3 separate injections one after another. Use a different prefilled syringe or a different prefilled autoinjector for each injection. You will take these injections once every 3 months.

It is important to follow the dose regimen as prescribed by your doctor.

Children 6 to 17 years of age and weighing at least 45 kg (99 pounds):

Use AJOVY 225 mg one time every month, using a prefilled syringe or a prefilled autoinjector.

It is important to follow the dose regimen as prescribed by your doctor.

Be aware that the monthly dose consists of a single subcutaneous injection.

Overdose:

If you think you, or a person you are caring for, have taken too much AJOVY, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed Dose:

If you miss a dose of AJOVY, take it as soon as possible. If you need to take the dose late, you will need to adjust your schedule:

If you take 225 mg of AJOVY, inject your next dose 1 month after the late dose.
If you take 675 mg of AJOVY, inject your next dose 3 months after the late dose.

If you have questions about your schedule, ask your healthcare professional.

Possible side effects from using AJOVY:

These are not all the possible side effects you may feel when taking AJOVY. If you experience any side effects not listed here, contact your healthcare professional.

Very common (may affect more than 1 in 10 people)

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

Pain, localized hardening in the skin raised red or purple skin patches, redness of the skin, severe itching 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 injection site. Hives, rash, dizziness, fatigue, gastrointestinal discomfort, joint pain, back pain.

If you have a troublesome symptom or side effect that is not listed above or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store refrigerated at 2°C to 8°C in the original outer carton to protect from light until time of use.
If necessary, AJOVY may be kept in the original carton at room temperature up to 25°C for a maximum of 7 days. After removal from the refrigerator, AJOVY must be used within 7 days or discarded.
Do not freeze. Do not expose to extreme heat or direct sunlight. Do not shake.

Keep out of reach and sight of children.

If you want more information about AJOVY:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website at http//www.tevacanadainnovation.ca or by calling Toll free number 1-833-302-0121.

Last Revised 2026-01-30

INSTRUCTIONS FOR USE – PREFILLED SYRINGE

AJOVY^®(FREMANEZUMAB) INJECTION FOR SUBCUTANEOUS USE

Prefilled syringe for subcutaneous injection only.

Read and follow the Instructions for Use for your AJOVY prefilled syringe before you start using it and each time you get a refill.

Important:

AJOVY prefilled syringe is for one-time use only. Put AJOVY in sharps disposal container right away after use. Do not throw away (dispose of) your used sharps disposal container in your household trash.
Before injecting, let AJOVY sit at room temperature for 30 minutes.
Keep AJOVY prefilled syringe out of the reach of small children.
After you remove the needle cap from AJOVY, to prevent infection, do not touch the needle.
Do NOT pull back on the plunger at any time, as this can break the prefilled syringe.
Do NOT inject AJOVY in your veins (intravenously).
Do NOT re-use your AJOVY prefilled syringe, as this could cause injury or infection.
Do NOT share your AJOVY prefilled syringe with another person. You may give another

person an infection or get an infection from them.

AJOVY may be self-administered by patients 13 years of age and older or administered by healthcare professionals and/or adult caregivers. In pediatric patients 6 to 12 years of age, AJOVY must be administered by a healthcare professional or adult caregiver. Administration should be performed by an individual who has been trained to administer the product.

Storage Conditions:

Store AJOVY in the refrigerator between 2 °C to 8°C.
Keep AJOVY in the carton it comes in to protect from light.
If needed, AJOVY may be stored at room temperature up to 25 °C in the carton it comes in for up to 7 days. Do not use AJOVY if it has been out of the refrigerator for 7 days or longer. Throw away AJOVY in a sharps disposal container if it has been out of the refrigerator for 7 days or longer.
Do NOT freeze. If AJOVY freezes, throw it away in a sharps disposal container.
Keep AJOVY out of extreme heat and direct sunlight.
Do NOT shake AJOVY.
Keep the syringe out of the reach of children.

AJOVY prefilled syringe (Before use). See Figure A. Appearance of the syringe before use

Diagram of a syringe with text

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Figure A - AJOVY prefilled syringe

After use: See Figure B.

Figure B - Appearance of the syringe after use

How do I inject AJOVY?

Read this before you inject.

Step 1. Check your prescription.

AJOVY comes as a single-dose (1 time) prefilled syringe. Your healthcare provider will prescribe the dose that is best for you.

If your healthcare professional prescribes the 225 mg monthly dose for you, take 1 injection monthly, using a prefilled syringe.
If your healthcare professional prescribes the 675 mg every 3 months dose for you, take 3 separate injections one after another, using a different prefilled syringe for each injection. You will take these injections once every 3 months.

Before you inject, always check the label of your single-dose prefilled syringe to make sure you have the correct medicine and the correct dose of AJOVY. If you are not sure of your dose, ask your healthcare professional.

Step 2. Remove the prefilled syringe from the carton.

You may need to use more than 1 prefilled syringe based on your prescribed dose.
Hold the prefilled syringe (as shown in Figure C).
Remove the syringe from the carton.
Do NOT shake the prefilled syringe at any time, as this could affect the way the medicine works.

A hand holding a syringe

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Figure C - How to manipulate the syringe

Step 3. Gather the supplies you will need to inject AJOVY.

Gather the following supplies (see Figure D) and the number of AJOVY 225 mg prefilled syringes you will need to give your prescribed dose:
- If your dose is 225 mg, you will need:
1 AJOVY 225 mg prefilled syringe.
alcohol swabs (not supplied)
gauze pads or cotton balls (not supplied)
sharps disposal or puncture-resistant container (not supplied).
- If your dose is 675 mg, you will need:
3 AJOVY 225 mg prefilled syringes
alcohol swabs (not supplied)
gauze pads or cotton balls (not supplied)
sharps disposal or puncture-resistant container (not supplied).

Figure D - Supplies needed for the injection of AJOVY

Tell your pharmacist or healthcare provider if you do not already have a sharps or puncture-resistant container.

Step 4. Let AJOVY reach room temperature.

Place the supplies you have gathered on a clean, flat surface.
Wait for 30 minutes to allow the medicine to reach room temperature.
Do NOT leave the prefilled syringe in direct sunlight, as this could damage the liquid medicine.
Do NOT warm up the AJOVY prefilled syringe using hot water, a microwave, or any other way than instructed, as this could damage the liquid medicine.

Step 5. Wash your hands.

Wash your hands with soap and water and dry well with a clean towel. Be careful not to touch your face or hair after washing your hands.

Step 6. Look closely at your AJOVY prefilled syringe.

Note: You may see air bubbles in the prefilled syringe. This is normal. Do NOT remove the air bubbles from the prefilled syringe before giving your injection. Injecting AJOVY with these air bubbles will not harm you.

Check that the liquid medicine in the prefilled syringe is clear and colourless to slightly yellow before you give your injection. (See Figure E). If the liquid has any particles in it, or is discoloured, cloudy, or frozen,		Do not use the prefilled syringe if it has any visible damage, such as cracks or leaks. See disposal instructions in Step 12.
		do not use the prefilled autoinjector. Call your healthcare provider or pharmacist.
Check that AJOVY appears on the prefilled syringe.		Do not use if you have been given the wrong medicine.
Check the expiration date printed on the prefilled syringe label.		Do not use the prefilled syringe if the expiration date has passed.

The above checks are all important to make sure the medicine is safe to use.

A close-up of a syringe

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Figure E - Checking the content of the prefilled syringe

Step 7. Choose your injection area.

Choose an injection area from the following areas (see Figure F):
1. o your stomach area (abdomen), avoid about 2 inches around the belly button.
2. o the front of your thighs, an area that is at least 2 inches above the knee and 2 inches below the groin.
3. o the back of your upper arms, in the fleshy area of the upper back portion.

Figure F - Injection areas

Note: There are some injection areas on your body that are hard to reach (like the back of your arm). You will need help from someone who has been instructed on how to give your injection if you cannot reach certain injection areas.

Step 8. 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, bruised, callused, tattooed, hard, or that has scars or stretch marks.
Do NOT inject AJOVY in the same injection site that you inject other medicine.
If you want to use the same body site for the three separate injections needed for the 675 mg dose, make sure the second and third injections are not at the same spot you used for the other injections.

Step 9. Remove needle cap and do not replace.

Pick up the body of the prefilled syringe with 1 hand.
Pull the needle cap straight off with your other hand (see Figure G). Do not twist.
Throw away the needle cap right away.
Do NOT put the needle cap back on the prefilled syringe, to avoid injury and infection.

Figure G - Removing the needle cap

Step 10. Give your injection following the 4 steps below.

1. Use your free hand to gently pinch up at least 1 inch of the skin that you have cleaned.	2. Insert the needle into the pinched skin at 45 to 90 degree angle	3. When the needle is all the way into your skin, use your thumb to push the plunger.	4. Push the plunger slowly all the way down as far as it will go to inject all of the medicine.

A close-up of a drawing of a person's hand

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Step 11. Remove the needle from your skin.

After you have injected all of the medicine, pull the needle straight out (see Figure H).
Do not recap the needle at any time to avoid injury and infection.

Figure H - Removing the needle

Step 12. 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
Do NOT re-use the prefilled syringe.

Step 13. Dispose of your prefilled syringe right away.

Put your used prefilled syringes, needles, and sharps in a Health Canada -cleared sharps disposal container right away after use.
Do NOT throw away (dispose of) loose needles, syringes, or prefilled syringes in your household trash. Do not recycle your used sharps disposal container.
If you do not have a Health Canada -cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labelled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be provincial or local laws about how you should throw away used syringes.

Do NOT dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

Injection Complete

INSTRUCTIONS FOR USE – PREFILLED AUTOINJECTOR

AJOVY^®(fremanezumab) injection for subcutaneous use

Prefilled autoinjector for subcutaneous injection only

Read and follow the Instructions for Use for your AJOVY prefilled autoinjector before you start using it and each time you get a refill.

Important:

AJOVY prefilled autoinjector is for single-time (one-time) use only. Put AJOVY in a sharps disposal right away after use. Do not throw away (dispose of) your used sharps disposal container in your household trash.
Before injecting, let AJOVY sit at room temperature for 30 minutes.
Keep AJOVY prefilled autoinjector out of the reach of small children.
After you remove the protective cap from AJOVY, to prevent infection, do not touch the needle.
Do NOT inject AJOVY in your veins (intravenously).
Do NOT re-use your AJOVY prefilled autoinjector as this could cause injury or infection.
Do not share your AJOVY prefilled autoinjector with another person. You may give another person an infection or get an infection from them.

Storage Conditions:

Store AJOVY in the refrigerator between 2°C to 8°C.
Keep AJOVY in the carton it comes in to protect from light.
If needed, AJOVY may be stored at room temperature up to 20°C to 25°C in the carton it comes in for up to 7 days . Do not use AJOVY if it has been out of the refrigerator for
- 7 days or longer. Throw away AJOVY in a sharps disposal container if it has been out of the refrigerator for 7 days or longer.
Do NOT freeze. If AJOVY freezes, throw it away in a sharps disposal container.
Keep AJOVY out of extreme heat and direct sunlight.
Do NOT shake AJOVY.

AJOVY prefilled autoinjector (Before use). See Figure A.

A close-up of a pen

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Figure A AJOVY prefilled autoinjector

AJOVY prefilled autoinjector (After use). See Figure B.

A diagram of a blue plunger

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Figure B Appearance of the autoinjector 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 gray stopper, as shown in Figure B.
When injecting AJOVY, hold the prefilled autoinjector so that your hand does not cover the viewing window.

Read this before you inject.

Step 1. Check your prescription.

AJOVY comes as a single-dose (1 time) prefilled autoinjector. Your healthcare provider will prescribe the dose that is best for you.

If your healthcare professional prescribes the 225 mg of AJOVY monthly dose for you, take 1 injection monthly, using a 225 mg prefilled AJOVY autoinjector.
If your healthcare professional prescribes the 675 mg of AJOVY every 3 months dose for you, take 3 separate injections, one after another, using a different 225 mg prefilled AJOVY autoinjector for each injection. You will take these injections once every 3 months.

Before you inject, always check the label of your single-dose prefilled autoinjector to make sure you have the correct medicine and the correct dose of AJOVY. If you are not sure of your dose, ask your healthcare professional.