Label: AJOVY- fremanezumab-vfrm injection

  • NDC Code(s): 51759-202-10, 51759-202-11, 51759-202-22, 51759-204-10, view more
  • Packager: Teva Pharmaceuticals USA, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated March 25, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use AJOVY safely and effectively. See full prescribing information for AJOVY. AJOVY® (fremanezumab-vfrm) injection, for subcutaneous ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    AJOVY is indicated for the preventive treatment of migraine in adults.
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Dosage - Two subcutaneous dosing options of AJOVY are available to administer the recommended dosage: 225 mg monthly, or - 675 mg every 3 months (quarterly), which is administered ...
  • 3 DOSAGE 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 ...
  • 4 CONTRAINDICATIONS
    AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema [see Warnings and ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1  Hypersensitivity Reactions - Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria, were reported with AJOVY in clinical trials. Most reactions were mild ...
  • 6 ADVERSE REACTIONS
    The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity Reactions [see Warnings and Precautions ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Exposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AJOVY during pregnancy. Healthcare providers are ...
  • 11 DESCRIPTION
    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 ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Fremanezumab-vfrm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. 12.2 ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Carcinogenicity studies of fremanezumab-vfrm were not conducted. Mutagenesis - Genetic toxicology studies of ...
  • 14 CLINICAL STUDIES
    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 ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - AJOVY (fremanezumab-vfrm) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution for subcutaneous administration. AJOVY is not ...
  • 17 PATIENT 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 - Provide guidance to ...
  • Patient Information
    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 ...
  • Instructions for Use
    AJOVY® (a-JO-vee) (fremanezumab-vfrm) injection - prefilled autoinjector, for subcutaneous use - For subcutaneous injection only. Read and follow the Instructions for Use for your AJOVY ...
  • Instructions for Use
    AJOVY® (a-JO-vee) (fremanezumab-vfrm) injection - prefilled syringe, for subcutaneous use -   For subcutaneous injection only. Read and follow the Instructions for Use for your AJOVY prefilled ...
  • PACKAGE/LABEL DISPLAY PANEL,Carton of 1 prefilled syringe
    NDC 51759-204-10 - Rx only - AJOVY® (fremanezumab-vfrm) injection 225 mg/1.5 mL - FOR SUBCUTANEOUS USE ONLY - One single-dose prefilled syringe - Store in refrigerator at 36°F to 46°F (2° to 8°C ...
  • PACKAGE/LABEL DISPLAY PANEL,Carton of 1 prefilled autoinjector
    NDC 51759-202-10 - Rx only - AJOVY (fremanezumab-vfrm) injection 225 mg/1.5 mL - FOR SUBCUTANEOUS USE ONLY - One single-dose prefilled autoinjector - Store in refrigerator at 36°F to 46°F (2° to 8°C) in ...
  • PACKAGE/LABEL DISPLAY PANEL,Carton of 3 prefilled autoinjectors
    NDC 51759-202-22 - Rx only - AJOVY (fremanezumab-vfrm) injection 225 mg/1.5 mL - FOR SUBCUTANEOUS USE ONLY - 3 x 225 mg/1.5 mL single-dose prefilled autoinjectors - Store in refrigerator at 36°F to 46°F ...
  • INGREDIENTS AND APPEARANCE
    Product Information