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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 ContentsTable of Contents
-
1 INDICATIONS AND USAGEAJOVY is indicated for the preventive treatment of migraine in adults.
-
2 DOSAGE AND ADMINISTRATION2.1 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 STRENGTHSAJOVY 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 CONTRAINDICATIONSAJOVY 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 PRECAUTIONS5.1 Hypersensitivity Reactions - Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria, were reported with AJOVY in clinical trials. Most reactions were mild ...
-
6 ADVERSE REACTIONSThe 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 POPULATIONS8.1 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 DESCRIPTIONFremanezumab-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 PHARMACOLOGY12.1 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 TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Carcinogenicity studies of fremanezumab-vfrm were not conducted. Mutagenesis - Genetic toxicology studies of ...
-
14 CLINICAL STUDIESThe 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 HANDLING16.1 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 INFORMATIONAdvise 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 InformationAJOVY® (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 UseAJOVY® (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 UseAJOVY® (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 syringeNDC 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 autoinjectorNDC 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 autoinjectorsNDC 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 APPEARANCEProduct Information