Ajovy
- Generic Name: fremanezumab-vfrm injection
- Brand Name: Ajovy
- Drug Class: CGRP Monoclonal Antibodies
Ajovy (Fremanezumab-vfrm Injection) side effects drug center
Ajovy Side Effects Center
What Is Ajovy?
Ajovy (fremanezumab-vfrm) is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults.
What Are Side Effects of Ajovy?
Common side effects if Ajovy include:
- injection site reactions (pain, swelling, and redness)
Dosage for Ajovy
Two subcutaneous dosing options of Ajovy are available to administer the recommended dosage: 225 mg monthly, or 675 mg every 3 months (quarterly). The 675 mg quarterly dosage is administered as three consecutive injections of 225 mg each.
What Drugs, Substances, or Supplements Interact with Ajovy?
Ajovy may interact with other drugs. Tell your doctor all medications and supplements you use.
Ajovy During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Ajovy; it is unknown how it would affect a fetus. It is unknown if Ajovy passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Ajovy (fremanezumab-vfrm) Injection, for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Ajovy Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
An allergic reaction to fremanezumab can occur up to 1 month after an injection.
Common side effects may include:
- pain, redness, or a hard lump where the medicine was injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Ajovy (Fremanezumab-vfrm Injection)
Ajovy Professional Information
SIDE EFFECTS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
Clinical 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.
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. | |||
Immunogenicity
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.
Read the entire FDA prescribing information for Ajovy (Fremanezumab-vfrm Injection)
© Ajovy Patient Information is supplied by Cerner Multum, Inc. and Ajovy Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.