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Ajovy (fremanezumab-vfrm) is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults.
Common side effects if Ajovy include:
AJOVY is a prescription medicine used for the preventive treatment of migraine in adults.
Fremanezumab-vfrm is a fully 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 syringe.
Each 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.
AJOVY is indicated for the preventive treatment of migraine in adults.
Two subcutaneous dosing options of AJOVY are available to administer the recommended dosage:
When switching dosage options, administer the first dose of the new regimen on the next scheduled date of administration. If a dose of AJOVY is missed, administer as soon as possible. Thereafter, AJOVY can be scheduled from the date of the last dose.
AJOVY is for subcutaneous use only.
AJOVY may be administered by healthcare professionals, patients, and/or caregivers. Prior to use, provide proper training to patients and/or caregivers on the preparation and administration of AJOVY prefilled syringe, including aseptic technique [see Instructions for Use]:
AJOVY is a sterile, clear to opalescent, colorless to slightly yellow solution, available as follows:
AJOVY (fremanezumab-vfrm) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution for subcutaneous administration.
The prefilled syringe cap is not made with natural rubber latex.
AJOVY is supplied as follows:
Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. Revised: Sep 2018
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
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.
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 [see Clinical Studies]. In the controlled trials, 87% of patients were female, 80% were White, and the mean age was 41 years.
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.
Table 1: Adverse Reactions Occurring with an Incidence of At Least 2% for Either Dosing Regimen of AJOVY and At Least 2% Greater Than Placebo in Studies 1 and 2
| Adverse Reaction | AJOVY 225 mg Monthly (n=290) % |
AJOVY 675 mg Quarterly (n=667) % |
Placebo Monthly (n=668) % |
| Injection site reactionsa | 43 | 45 | 38 |
| a Injection site reactions include multiple related adverse event terms, such as injection site pain, induration, and erythema. | |||
As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to fremanezumab-vfrm in the studies described below with the incidence of antibodies in other studies to other products may be misleading. Clinical immunogenicity of AJOVY was monitored by analyzing anti-drug antibodies (ADA) and neutralizing antibodies in drug-treated patients. The data reflect the percentage of patients whose test results were positive for antibodies to AJOVY in specific assays.
In 3-month placebo-controlled studies, treatment-emergent ADA responses were observed in 6 out of 1701 (0.4%) AJOVY-treated patients. One of the 6 patients developed anti-AJOVY neutralizing antibodies at Day 84. In the ongoing long-term open-label study, ADA were detected in 1.6% of patients (30 out of 1888). Out of 30 ADA-positive patients, 17 had a neutralizing activity in their post-dose samples. Although these data do not demonstrate an impact of anti-fremanezumab-vfrm antibody development on the efficacy or safety of AJOVY in these patients, the available data are too limited to make definitive conclusions.
No Information Provided
Included as part of the "PRECAUTIONS" Section
Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria, were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration.
If a hypersensitivity reaction occurs, consider discontinuing AJOVY, and institute appropriate therapy.
Advise the patient and/or caregiver to read the FDA-approved patient labeling (PATIENT INFORMATION and Instructions for Use).
Provide guidance to patients and caregivers on proper subcutaneous administration technique, including aseptic technique, and how to use the single-dose prefilled syringe [see DOSAGE AND ADMINISTRATION]. Instruct patients and/or caregivers to read and follow the Instructions for Use each time they use AJOVY.
Instruct patients prescribed the regimen of 675 mg every 3 months to administer the dosage as three consecutive subcutaneous injections of 225 mg each [see DOSAGE AND ADMINISTRATION].
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 immediately if signs or symptoms of hypersensitivity reactions occur [see WARNINGS AND PRECAUTIONS].
Carcinogenicity studies of fremanezumab-vfrm were not conducted.
Genetic toxicology studies of fremanezumab-vfrm were not conducted.
When fremanezumab-vfrm (0, 50, 100, or 200 mg/kg) was administered to male and female rats by weekly subcutaneous injection prior to and during mating and continuing in females throughout organogenesis, no adverse effects on male or female fertility were observed. The highest dose tested was associated with plasma exposures (AUC) approximately 2 times that in humans at a dose of 675 mg.
There are no adequate data on the developmental risk associated with the use of AJOVY in pregnant women. AJOVY has a long half-life [see CLINICAL PHARMACOLOGY]. This should be taken into consideration for women who are pregnant or plan to become pregnant while using AJOVY. Administration of fremanezumab-vfrm to rats and rabbits during the period of organogenesis or to rats throughout pregnancy and lactation at doses resulting in plasma levels greater than those expected clinically did not result in adverse effects on development [see Animal Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The estimated rate of major birth defects (2.2-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine.
Disease-Associated Maternal and/or Embryo/Fetal Risk
Published data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy.
Animal Data
When fremanezumab-vfrm (0, 50, 100, or 200 mg/kg) was administered to male and female rats by weekly subcutaneous injection prior to and during mating and continuing in females throughout organogenesis, no adverse embryofetal effects were observed. The highest dose tested was associated with plasma exposures (AUC) approximately 2 times that in humans at a dose of 675 mg.
Administration of fremanezumab-vfrm (0, 10, 50, or 100 mg/kg) weekly by subcutaneous injection to pregnant rabbits throughout the period of organogenesis produced no adverse effects on embryofetal development. The highest dose tested was associated with plasma AUC approximately 3 times that in humans (675 mg).
Administration of fremanezumab-vfrm (0, 50, 100, or 200 mg/kg) weekly by subcutaneous injection to female rats throughout pregnancy and lactation resulted in no adverse effects on preand postnatal development. The highest dose tested was associated with plasma AUC approximately 2 times that in humans (675 mg).
There are no data on the presence of fremanezumab-vfrm in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for AJOVY and any potential adverse effects on the breastfed infant from AJOVY or from the underlying maternal condition.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of AJOVY did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
No Information Provided
AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients [see WARNINGS AND PRECAUTIONS].
Fremanezumab-vfrm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.
The relationship between the pharmacodynamic activity and the mechanism(s) by which fremanezumab-vfrm exerts its clinical effects is unknown.
After single subcutaneous (SC) administrations of 225 mg, 675 mg, and 900 mg fremanezumabvfrm, median time to maximum concentrations (tmax) was 5 to 7 days. Dose-proportionality, based on population PK, was observed between 225 mg to 900 mg. Steady state was achieved by approximately 168 days (about 6 months) following 225 mg SC monthly and 675 mg SC quarterly dosing regimens. Median accumulation ratio, based on once-monthly and once-quarterly dosing regimens, is approximately 2.3 and 1.2, respectively.
Fremanezumab-vfrm has an apparent volume of distribution of approximately 6 liters, suggesting minimal distribution to the extravascular tissues.
Similar to other monoclonal antibodies, fremanezumab-vfrm is degraded by enzymatic proteolysis into small peptides and amino acids.
Fremanezumab-vfrm apparent clearance was approximately 0.141 L/day. Fremanezumab-vfrm was estimated to have a half-life of approximately 31 days.
A population PK analysis assessing effects of age, race, sex, and weight was conducted on data from 2287 subjects. No dose adjustments are recommended for AJOVY.
Hepatic/renal impairment is not expected to affect the pharmacokinetics of fremanezumab. A population PK analysis of integrated data from the AJOVY clinical studies did not reveal a difference in the pharmacokinetics of fremanezumab in patients with mild hepatic impairment, relative to those with normal hepatic function. There were only 4 patients with moderate hepatic impairment, and no patient with severe hepatic impairment in fremanezumab clinical studies. No dedicated hepatic/renal impairment studies were conducted to assess the effect of hepatic or renal impairment on the pharmacokinetics of fremanezumab.
Fremanezumab is not metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely. Additionally, the effects of medications for the acute treatment (specifically analgesics, ergots, and triptans) and preventive treatment of migraine were evaluated in a population PK model, and found not to influence fremanezumab exposure.
The efficacy of AJOVY was evaluated as a preventive treatment of episodic or chronic migraine in two multicenter, randomized, 3-month, double-blind, placebo-controlled studies (Study 1 and Study 2, respectively).
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 2.
Table 2: Efficacy Endpoints in Study 1
| Study 1 Efficacy Endpoint |
AJOVY 225 mg Monthly (N=287) |
AJOVY 675 mg Quarterly (N=288) |
Placebo (N=290) |
| Monthly migraine days (MMD) | |||
| Baseline migraine days | 8.9 | 9.2 | 9.1 |
| Change from baseline | -3.7 | -3.4 | -2.2 |
| Difference from placebo | -1.5 | -1.2 | |
| p-value | <0.001 | <0.001 | |
| ≥50% MDD responders | |||
| % responders | 47.7% | 44.4% | 27.9% |
| Difference from placebo | 19.8% | 16.5% | |
| p-value | <0.001 | <0.001 | |
| Monthly acute migraine-specific medication days | |||
| Change from baseline | -3.0 | -2.9 | -1.6 |
| Difference from placebo | -1.4 | -1.3 | |
| p-value | <0.001 | <0.001 | |
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 1a
 |
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
 |
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 3.
Table 3: Efficacy Endpoints in Study 2
| Study 2 Efficacy Endpoint |
AJOVY 225 mga Monthly (N=375) |
AJOVY 675 mg Quarterly (N=375) |
Placebo (N=371) |
| Baseline headache days of any severityb | 20.3 | 20.4 | 20.3 |
| Baseline headache days of at least moderate severityc | 12.8 | 13.2 | 13.3 |
| Change from baseline in the monthly average number of headache days of at least moderate severity | -4.6 | -4.3 | -2.5 |
| Difference from placebo | -2.1 | -1.8 | |
| p-value | <0.001 | <0.001 | |
| Change from baseline in the monthly average number of migraine days in patients | -5.0 | -4.9 | -3.2 |
| Change from baseline in monthly average number of headache days of at least moderate severity at 4 weeks after 1st dose | -4.6 | -4.6 | -2.3 |
| Percentage of patients with ≥ 50% reduction in monthly average number of headache days of at least moderate severity | 40.8% | 37.6% | 18.1% |
| Change from baseline in monthly average number of days of acute headache medication | -4.2 | -3.7 | -1.9 |
|
a In Study 2, patients received a 675 mg starting dose. b Used for chronic migraine diagnosis. c Used for primary endpoint analysis. |
|||
Figure 3 displays the mean change from baseline in the average monthly number of migraine days in Study 2.
Figure 3: Change from Baseline in Monthly Headache Days of At Least Moderate Severity in Study 2a
 |
Figure 4 shows the distribution of change from baseline in monthly migraine days 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.
AJOVY™
(a-JO-vee)
(fremanezumab-vfrm) injection
for subcutaneous use
What is AJOVY?
AJOVY is a prescription medicine used for the preventive treatment of migraine in adults.
It is not known if AJOVY is safe and effective in children.
Who should not use AJOVY?
Do not use AJOVY if you are allergic to fremanezumab-vfrm or any of the ingredients in AJOVY. See the end of this leaflet for a complete list of the ingredients in AJOVY.
Before you use AJOVY, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine.
How should I use AJOVY?
What are the possible side effects of AJOVY?
AJOVY may cause serious side effects, including:
The most common side effects of AJOVY include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of AJOVY. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store AJOVY?
Keep AJOVY prefilled syringe out of the reach of small children.
General information about the safe and effective use of AJOVY.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use AJOVY for a condition for which it was not prescribed. Do not give AJOVY to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about AJOVY that is written for health professionals.
What are the ingredients in AJOVY?
Active ingredient: fremanezumab-vfrm
Inactive ingredients: disodium ethylenediaminetetraacetic acid dihydrate (EDTA), L-histidine, L-histidine hydrochloride monohydrate, polysorbate-80, sucrose, and Water for Injection
The prefilled syringe cap is not made with natural rubber latex.
Instructions for Use
AJOVY™
(a-JO-vee)
(fremanezumab-vfrm) injection
for subcutaneous use
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:
You may give AJOVY yourself. If you feel uncomfortable, 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:
AJOVY prefilled syringe (Before use). See Figure A.
 |
Figure A
AJOVY prefilled syringe (After use). See Figure B.
 |
Figure B
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.
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.
Step 2. Remove the prefilled syringe from the carton.
 |
Figure C
Step 3. Gather the supplies you will need to inject AJOVY.
 |
Figure D
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.
 |
Step 5. Wash 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.
The above checks are all important to make sure the medicine is safe to use.
 |
Figure E
Step 7. Choose your injection area.
 |
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.
Step 9. Remove needle cap and do not replace.
 |
Figure G
Step 10. Give your injection following the 4 steps below.
 |
Step 11. Remove the needle from your skin.
 |
Figure H
Step 12. Apply pressure at the injection site.
Step 13. Dispose of your prefilled syringe right away.
 |
Injection Complete
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
