Clinical Information
Gen. Code and Des.
80875 fremanezumab-vfrm SUBCUT AUTO INJCT 225 MG/1.5
GCN and Des.
47862 fremanezumab-vfrm SUBCUT AUTO INJCT 225 MG/1.5
Strength
225MG
Dose Form
AUTO-INJECTOR (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
28321200 CALCITONIN GENE-RELATED PEPTIDE ANTAG.
Active Ingredients
17742 fremanezumab-vfrm
Inactive Ingredients
2551 polysorbates 9005645
2598 sucrose 57501
3785 edetic acid 60004
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
