Brand Name
AJOVY
Generic Name
Fremanezumab-Vfrm
View Brand Information FDA approval date: September 15, 2018
Form: Injection
What is AJOVY (Fremanezumab-Vfrm)?
AJOVY is indicated for the preventive treatment of migraine in adults. AJOVY is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults.
Approved To Treat
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Brand Information
AJOVY (fremanezumab-vfrm)
1INDICATIONS AND USAGE
AJOVY is indicated for:
- the preventive treatment of migraine in adults, and
- the preventive treatment of episodic migraine in pediatric patients who are 6 to 17 years of age and who weigh 45 kg or more.
2DOSAGE FORMS AND STRENGTHS
AJOVY is a sterile, clear to opalescent, colorless to slightly yellow solution, available as follows:
- Injection: 225 mg/1.5 mL single-dose prefilled autoinjector
- Injection: 225 mg/1.5 mL single-dose prefilled syringe
3CONTRAINDICATIONS
AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema
4ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
- Hypersensitivity Reactions
- Hypertension
- Raynaud’s Phenomenon
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in clinical practice.
Adults
The safety of AJOVY was evaluated in 2512 patients with migraine who received at least 1 dose of AJOVY, representing 1279 patient-years of exposure. Of these, 1730 patients were exposed to AJOVY 225 mg monthly or AJOVY 675 mg quarterly for at least 6 months, 775 patients for at least 12 months, and 138 patients for at least 15 months. In placebo-controlled clinical trials (Studies 1 and 2), 662 patients received AJOVY 225 mg monthly for 12 weeks (with or without a loading dose of 675 mg), and 663 patients received AJOVY 675 mg quarterly for 12 weeks
The most common adverse reactions in the clinical trials for the preventive treatment of migraine (incidence at least 5% and greater than placebo) were injection site reactions. The adverse reactions that most commonly led to discontinuations were injection site reactions (1%). Table 1 summarizes adverse reactions reported in the 3-month placebo-controlled studies (Study 1 and Study 2), and the 1-month follow-up period after those studies.
a Injection site reactions include multiple related adverse event terms, such as injection site pain, induration, and erythema.
Pediatric Patients 6 to 17 Years of Age
The safety of AJOVY was evaluated in 225 pediatric patients 6 to 17 years of age with episodic migraine who received at least one dose of AJOVY. Of these patients, 209 received AJOVY monthly for at least 6 months and 100 received AJOVY for at least 12 months. In the placebo-controlled trial (Study 3), 123 pediatric patients with episodic migraine were treated with AJOVY
4.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of AJOVY. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: Anaphylactic reactions and angioedema [see Contraindications (
Vascular Disorders: Hypertension [see Warnings and Precautions (, Raynaud’s phenomenon [see Warnings and Precautions (
5DESCRIPTION
Fremanezumab-vfrm is a humanized IgG2Δa/kappa monoclonal antibody specific for calcitonin gene-related peptide (CGRP) ligand. Fremanezumab-vfrm is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. The antibody consists of 1324 amino acids and has a molecular weight of approximately 148 kDa.
AJOVY (fremanezumab-vfrm) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution for subcutaneous injection, supplied in a single-dose 225 mg/1.5 mL prefilled autoinjector and a single-dose 225 mg/1.5 mL prefilled syringe.
Each prefilled autoinjector or prefilled syringe delivers 1.5 mL of solution containing 225 mg fremanezumab-vfrm, disodium ethylenediaminetetraacetic acid dihydrate (EDTA) (0.204 mg), L-histidine (0.815 mg), L-histidine hydrochloride monohydrate (3.93 mg), polysorbate-80 (0.3 mg), sucrose (99 mg), and Water for Injection, and has a pH of 5.5.
6CLINICAL STUDIES
Adults
The efficacy of AJOVY was evaluated as a preventive treatment of episodic or chronic migraine in adult patients in two multicenter, randomized, 3-month, double-blind, placebo-controlled studies (Study 1 and Study 2, respectively).
Episodic Migraine
Study 1 (NCT 02629861) included adults with a history of episodic migraine (patients with <15 headache days per month). All patients were randomized (1:1:1) to receive subcutaneous injections of either AJOVY 675 mg every three months (quarterly), AJOVY 225 mg monthly, or placebo monthly, over a 3-month treatment period. Patients were allowed to use acute headache treatments during the study. A subset of patients (21%) was allowed to use one additional concomitant preventive medication.
The study excluded patients with a history of significant cardiovascular disease, vascular ischemia, or thrombotic events, such as cerebrovascular accident, transient ischemic attacks, deep vein thrombosis, or pulmonary embolism.
The primary efficacy endpoint was the mean change from baseline in the monthly average number of migraine days during the 3-month treatment period. Secondary endpoints included the proportion of patients reaching at least a 50% reduction in monthly average number of migraine days during the 3-month treatment period, the mean change from baseline in the monthly average number of days of use of any acute headache medication during the 3-month treatment period, and the mean change from baseline in the number of migraine days during the first month of the treatment period.
In Study 1, a total of 875 patients (742 females, 133 males), ranging in age from 18 to 70 years, were randomized. A total of 791 patients completed the 3-month double-blind phase. The mean migraine frequency at baseline was approximately 9 migraine days per month, and was similar across treatment groups.
Both monthly and quarterly dosing regimens of AJOVY demonstrated statistically significant improvements for efficacy endpoints compared to placebo over the 3-month period, as summarized in Table 3.
Figure 1 displays the mean change from baseline in the average monthly number of migraine days in Study 1.
Figure 1: Change from Baseline in Monthly Migraine Days in Study 1
Figure 2 shows the distribution of change from baseline in mean monthly migraine days in bins of 2 days by treatment group in Study 1. A treatment benefit over placebo for both doses of AJOVY is seen across a range of changes from baseline in monthly migraine days.
Figure 2: Distribution of Change from Baseline in Mean Monthly Migraine Days by Treatment Group in Study 1
Chronic Migraine
Study 2 (NCT 02621931) included adults with a history of chronic migraine (patients with ≥15 headache days per month). All patients were randomized (1:1:1) to receive subcutaneous injections of either AJOVY 675 mg starting dose followed by 225 mg monthly, 675 mg every 3 months (quarterly), or placebo monthly, over a 3-month treatment period. Patients were allowed to use acute headache treatments during the study. A subset of patients (21%) was allowed to use one additional concomitant, preventive medication.
The study excluded patients with a history of significant cardiovascular disease, vascular ischemia, or thrombotic events, such as cerebrovascular accident, transient ischemic attacks, deep vein thrombosis, or pulmonary embolism.
The primary efficacy endpoint was the mean change from baseline in the monthly average number of headache days of at least moderate severity during the 3-month treatment period. The secondary endpoints were the mean change from baseline in the monthly average number of migraine days during the 3-month treatment period, the proportion of patients reaching at least 50% reduction in the monthly average number of headache days of at least moderate severity during the 3-month treatment period, the mean change from baseline in the monthly average number of days of use of any acute headache medication during the 3-month treatment period, and the mean change from baseline in the number of headache days of at least moderate severity during the first month of treatment.
In Study 2, a total of 1130 patients (991 females, 139 males), ranging in age from 18 to 70 years, were randomized. A total of 1034 patients completed the 3-month double-blind phase.
Both monthly and quarterly dosing regimens of AJOVY treatment demonstrated statistically significant improvement for key efficacy outcomes compared to placebo, as summarized in Table 4.
aIn Study 2, patients received a 675 mg starting dose.
bUsed for chronic migraine diagnosis.
cUsed for primary endpoint analysis.
bUsed for chronic migraine diagnosis.
cUsed for primary endpoint analysis.
Figure 3 displays the mean change from baseline in the average monthly number of headache days of at least moderate severity in Study 2.
Figure 3: Change from Baseline in Monthly Headache Days of At Least Moderate Severity in Study 2
Figure 4 shows the distribution of change from baseline in monthly headache days of at least moderate severity at month 3 in bins of 3 days by treatment group. A treatment benefit over placebo for both dosing regimens of AJOVY is seen across a range of changes from baseline in headache days.
Figure 4: Distribution of Mean Change from Baseline in Monthly Headache Days of At Least Moderate Severity by Treatment Group in Study 2
*In Study 2, patients received a 675 mg starting dose.
Pediatric Patients 6 to 17 Years of Age
The efficacy of AJOVY for the preventive treatment of episodic migraine in pediatric patients 6 to 17 years of age was evaluated in a multicenter, randomized, 3-month, double-blind, placebo-controlled study (Study 3).
Episodic Migraine
Study 3 (NCT 04458857) included pediatric patients 6 to 17 years of age with a history of episodic migraine (patients with <15 headache days per month). All patients were randomized (1:1) to receive monthly subcutaneous injections of either AJOVY or placebo, over a 3-month period. Patients who weighed 45 kg or more received AJOVY 225 mg and patients who weighed under 45 kg received AJOVY 120 mg
The primary efficacy endpoint was the mean change from baseline in the monthly average number of migraine days during the 3-month treatment period. Secondary endpoints included the proportion of patients reaching at least a 50% reduction in monthly average number of migraine days during the 3-month treatment period; the mean change from baseline in the monthly average number of days of use of any acute headache medication during the 3-month treatment period; and the mean change from baseline in monthly average number of headache days of at least moderate severity during the 3-month treatment period.
In Study 3, a total of 235 patients (130 females, 105 males) were randomized. A total of 225 patients completed the 3-month, double-blind treatment period.
AJOVY demonstrated statistically significant improvements for efficacy endpoints compared to placebo over the 3-month period, as summarized in Table 5.
a One patient in the placebo group was excluded from the analysis due to not having at least 10 days of post-baseline efficacy data.
Figure 5 displays the mean change from baseline in the average monthly number of migraine days in Study 3.
Figure 5: Distribution of Change from Baseline in Mean Monthly Migraine Days by Placebo and Combined AJOVY Group (Full Analysis Set) in Study 3.
7PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Information on Preparation and Administration
Instruct patients who are 13 years and older and/or caregivers on proper subcutaneous administration technique, including aseptic technique, and how to use the single-dose prefilled syringe
Instruct patients who are prescribed the regimen of 675 mg every 3 months to administer the dosage as three consecutive subcutaneous injections of 225 mg each
Hypersensitivity Reactions
Inform patients about the signs and symptoms of hypersensitivity reactions and that these reactions can occur up to 1 month after administration. Advise patients to contact their healthcare provider if signs or symptoms of hypersensitivity reactions occur and to seek immediate medical attention if they experience serious or severe hypersensitivity reactions
Hypertension
Inform patients that hypertension can develop or pre-existing hypertension can worsen with AJOVY, and that they should contact their healthcare provider if they experience elevation in their blood pressure
Raynaud's Phenomenon
Inform patients that Raynaud’s phenomenon can develop or worsen with AJOVY. Advise patients to discontinue AJOVY and contact their healthcare provider if they experience signs or symptoms of Raynaud’s phenomenon
Pregnancy
Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AJOVY during pregnancy
Manufactured by:
AJOVY
©2025 Teva Pharmaceuticals USA, Inc.
AJO-012
8Patient Information
This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 8/2025
9Instructions for Use
AJOVY
For subcutaneous injection only.
Read and follow the
Important:
- AJOVY prefilled autoinjector is for single-time (one-time) use only. Put AJOVY in a FDA-cleared sharps disposal or puncture-resistant 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 autoinjector out of the reach of small children.
- After you remove the protective cap from AJOVY, to prevent infection,
- 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.
You or your caregiver may give AJOVY. You should not get your first dose of AJOVY until you or your caregiver receive training from a healthcare provider on the right way to use AJOVY.
Storage Conditions:
- Store AJOVY in the refrigerator between 36°F to 46°F (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 86°F (30°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 (dispose of) AJOVY in a sharps disposal or puncture-resistant container if it has been out of the refrigerator for 7 days or longer. Once stored at room temperature, do not place back in the refrigerator.
- 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.
Figure A
AJOVY prefilled autoinjector (After use). See Figure B.
Figure B
- The blue plunger moves down the viewing window during the injection. The blue plunger fills the window when the injection is complete.
- When injecting AJOVY, hold the prefilled autoinjector so that your hand does not cover the viewing window.
Step 1. Check the dose your healthcare provider has prescribed.
AJOVY comes as a single-dose (one time) prefilled autoinjector. Your healthcare provider will prescribe the dose that is best for you.
- If your healthcare provider has prescribed 225 mg of AJOVY each month for you, give 1 injection each month, using a 225 mg prefilled AJOVY autoinjector.
- If your healthcare provider has prescribed 675 mg of AJOVY every 3 months for you, give 3 separate injections, one after another, using a different 225 mg prefilled AJOVY autoinjector for each injection. Give these injections 1 time 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 provider.
How do I inject AJOVY?
Step 2. Remove the prefilled autoinjector from the carton.
- You may need to use more than 1 prefilled autoinjector depending on your prescribed dose.
- Remove the autoinjector from the carton (see Figure C).
- Do not shake the prefilled autoinjector at any time, as this could affect the way the medicine works.
Important: If there are any unused autoinjectors left in the carton, put the carton and unused autoinjectors back in the refrigerator.
Figure C
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 autoinjectors you will need to give your prescribed dose:
- If your dose is 225 mg, you will need 1 AJOVY 225 mg prefilled autoinjector.
- If your dose is 675 mg, you will need 3 AJOVY 225 mg prefilled autoinjectors.
- Alcohol swabs (not supplied).
- Gauze pads or cotton balls (not supplied).
- Sharps disposal or puncture-resistant container (not supplied).
Figure D
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 autoinjector in direct sunlight.
- Do not warm up the AJOVY prefilled autoinjector using a heat source such as hot water or a microwave.
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 autoinjector.
Note: You may see air bubbles in the prefilled autoinjector. This is normal. Do not remove the air bubbles from the prefilled autoinjector before giving your injection.
Injecting AJOVY with these air bubbles will not harm you.
Figure E
Step 7: Choose your injection area.
- Choose an injection area from the following areas (see Figure F):
- your
- the
- the
Figure F
Note: There are some injection areas on your body that are hard to reach (like the back of your arm). You may 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. Let your skin dry.
- 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 injection area for the 3 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 protective cap and do not replace.
- Pick up the prefilled autoinjector in 1 hand.
- Hold the prefilled autoinjector as shown in Figure G and pull the protective cap straight off with your other hand. Do not twist.
- Throw away the protective cap right away.
- Do not put the protective cap back on the prefilled autoinjector, to avoid injury and infection.
Figure G
Step 10. Give your injection.
- 10.1 Place the prefilled autoinjector at a 90 degree angle against your skin at the injection site you have cleaned (see Figure H).
Figure H
10.3 Check that the blue plunger has filled the viewing window and remove the autoinjector from the skin by lifting the prefilled autoinjector straight up (see Figure I).
Note: When the blue plunger has filled the viewing window you will be able to see the gray stopper.
As the prefilled autoinjector is lifted from the skin, the needle shield returns to the original (before use) position and locks into place, covering the needle.
Do not try to put the protective cap back on the used prefilled autoinjector as it is no longer needed.
Do not try to re-use the prefilled autoinjector.
Figure I
Step 11. Apply pressure to the injection site.
- Use a clean, dry cotton ball, or gauze pad to
- Do not rub the injection site.
- Do not re-use the prefilled autoinjector.
Step 12. Dispose of your prefilled autoinjector right away.
- Put your used prefilled autoinjectors in a FDA-cleared sharps disposal container right away after use.
- Do not throw away (dispose of) prefilled autoinjectors in your household trash. Do not recycle your used sharps disposal container.
- If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- 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 state or local laws about how you should throw away used autoinjectors. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal
- 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
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
©2025 Teva Pharmaceuticals USA, Inc.
AJOIFU-AI-005
10Instructions for Use
AJOVY
For subcutaneous injection only.
Read and follow the
Important:
- AJOVY prefilled syringe is for single-time (one-time) use only. Put AJOVY in a FDA-cleared sharps disposal or puncture-resistant 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 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.
You or your caregiver may give AJOVY. You should not get your first dose of AJOVY until you or your caregiver receive training from a healthcare provider on the right way to use AJOVY.
Storage Conditions:
- Store AJOVY in the refrigerator between 36°F to 46°F (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 86°F (30°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 (dispose of) AJOVY in a sharps disposal or puncture-resistant container if it has been out of the refrigerator for 7 days or longer. Once stored at room temperature, do not place back in the refrigerator.
- 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 syringe (Before use). See Figure A.
Figure A
AJOVY prefilled syringe (After use). See Figure B.
Figure B
Step 1. Check the dose your healthcare provider has prescribed.
AJOVY comes as a single-dose (one time) prefilled syringe. Your healthcare provider will prescribe the dose that is best for you.
- If your healthcare provider has prescribed 225 mg of AJOVY each month for you, give 1 injection each month using a 225 mg prefilled AJOVY syringe.
- If your healthcare provider has prescribed 675 mg of AJOVY every 3 months for you, give 3 separate injections, one after another, using a different 225 mg prefilled AJOVY syringe for each injection. Give these injections 1 time 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 provider.
How do I inject AJOVY?
Step 2. Remove the prefilled syringe from the carton.
- You may need to use more than 1 prefilled syringe depending on your prescribed dose.
- Hold the prefilled syringe (see 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.
Figure C
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.
- 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
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.
- Do not warm up the AJOVY prefilled syringe using a heat source such as hot water or a microwave.
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.
Figure E
Step 7. Choose your injection area.
- Choose an injection area from the following areas (see Figure F):
- your
- the
- the
Figure F
Note: There are some injection areas on your body that are hard to reach (like the back of your arm). You may 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. Let your skin dry.
- 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 injection area for the 3 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
Step 10. Give your injection following the 4 steps below.
Step 11. Remove the needle from your skin.
- After you have injected all of the medicine,
- Do not recap the needle at any time to avoid injury and infection.
Figure H
Step 12. Apply pressure to the injection site.
- Use a clean, dry cotton ball or gauze to
- 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 FDA-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 FDA-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 labeled 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 state or local laws about how you should throw away used syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal
- 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
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
©2025 Teva Pharmaceuticals USA, Inc.
AJOIFU-PFS-005
Revised: 8/2025
11PACKAGE/LABEL DISPLAY PANEL,Carton of 1 prefilled syringe
NDC 51759-204-10
Rx onlyAJOVYFOR SUBCUTANEOUS USE ONLYOne single-dose prefilled syringe
Store in refrigerator at 36°F to 46°F (2° to 8°C) in the original carton to protect from light. DO NOT FREEZE. DO NOT SHAKE. If needed, AJOVY® may be kept at room temperature up to 86°F (30°C) for 7 days. Once stored at room temperature, do not place back in the refrigerator. Discard after 7 days.
Rx onlyAJOVYFOR SUBCUTANEOUS USE ONLYOne single-dose prefilled syringe
Store in refrigerator at 36°F to 46°F (2° to 8°C) in the original carton to protect from light. DO NOT FREEZE. DO NOT SHAKE. If needed, AJOVY® may be kept at room temperature up to 86°F (30°C) for 7 days. Once stored at room temperature, do not place back in the refrigerator. Discard after 7 days.
OPEN HERE
12PACKAGE/LABEL DISPLAY PANEL,Carton of 1 prefilled autoinjector
NDC 51759-202-10
Rx only
One single-dose prefilled autoinjector
Store in refrigerator at 36°F to 46°F (2° to 8°C) in the original carton to protect from light. DO NOT FREEZE. DO NOT SHAKE. If needed, AJOVY® may be kept at room temperature up to 86°F (30°C) for 7 days. Once stored at room temperature, do not place back in the refrigerator. Discard after 7 days.
Rx only
One single-dose prefilled autoinjector
Store in refrigerator at 36°F to 46°F (2° to 8°C) in the original carton to protect from light. DO NOT FREEZE. DO NOT SHAKE. If needed, AJOVY® may be kept at room temperature up to 86°F (30°C) for 7 days. Once stored at room temperature, do not place back in the refrigerator. Discard after 7 days.
OPEN HERE
13PACKAGE/LABEL DISPLAY PANEL,Carton of 3 prefilled autoinjectors
NDC 51759-202-22
Rx only
3 x 225 mg/1.5 mL single-dose prefilled autoinjectors
Store in refrigerator at 36°F to 46°F (2° to 8°C) in the original carton to protect from light. DO NOT FREEZE. DO NOT SHAKE. If needed, AJOVY® may be kept at room temperature up to 86°F (30°C) for 7 days. Once stored at room temperature, do not place back in the refrigerator. Discard after 7 days.
Rx only
3 x 225 mg/1.5 mL single-dose prefilled autoinjectors
Store in refrigerator at 36°F to 46°F (2° to 8°C) in the original carton to protect from light. DO NOT FREEZE. DO NOT SHAKE. If needed, AJOVY® may be kept at room temperature up to 86°F (30°C) for 7 days. Once stored at room temperature, do not place back in the refrigerator. Discard after 7 days.
OPEN HERE
