AJOVY- fremanezumab-vfrm injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FREMANEZUMAB (UNII: PF8K38CG54) (FREMANEZUMAB - UNII:PF8K38CG54)

Available from:

Teva Pharmaceuticals USA, Inc.

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

AJOVY- FREMANEZUMAB-VFRM INJECTION
TEVA PHARMACEUTICALS USA, INC.
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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 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