Country: United States
Language: English
Source: NLM (National Library of Medicine)
FREMANEZUMAB (UNII: PF8K38CG54) (FREMANEZUMAB - UNII:PF8K38CG54)
Teva Pharmaceuticals USA, Inc.
SUBCUTANEOUS
PRESCRIPTION DRUG
AJOVY is indicated for the preventive treatment of migraine in adults. 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 Precautions (5.1)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AJOVY during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-833-927-2605 or visiting www.tevamigrainepregnancyregistry.com. Risk Summary 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 (12.3)] . 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 throu
AJOVY (fremanezumab-vfrm) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution for subcutaneous administration. AJOVY is not made with natural rubber latex. AJOVY is supplied as follows: Prefilled Autoinjector Prefilled Syringe
Biologic Licensing Application
AJOVY- FREMANEZUMAB-VFRM INJECTION TEVA PHARMACEUTICALS USA, INC. ---------- 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 USE INITIAL U.S. APPROVAL: 2018 INDICATIONS AND USAGE AJOVY is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults. (1) DOSAGE AND ADMINISTRATION For subcutaneous use only. (2.1, 2.2) Two subcutaneous dosing options of AJOVY are available to administer the recommended dosage: 225 mg monthly, or 675 mg every 3 months (quarterly) (2.1) The 675 mg quarterly dosage is administered as three consecutive injections of 225 mg each. (2.1) Administer in the abdomen, thigh, or upper arm subcutaneously. (2.2) See Dosage and Administration for important administration instructions. (2.2) DOSAGE FORMS AND STRENGTHS Injection: 225 mg/1.5 mL solution in a single-dose prefilled autoinjector. (3) Injection: 225 mg/1.5 mL solution in a single-dose prefilled syringe. (3) CONTRAINDICATIONS AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. (4) WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: If hypersensitivity occurs, consider discontinuing AJOVY and institute appropriate therapy. (5.1) ADVERSE REACTIONS The most common adverse reactions (≥5% and greater than placebo) were injection site reactions. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TEVA PHARMACEUTICALS AT 1-888-483- 8279 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_. SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 10/2022 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage 2.2 Important Administration Instructions 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity Reactions 6 ADVERSE REAC Read the complete document