AJOVY® (fremanezumab-vfrm) injection

Contraindications: AJOVY® is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.

Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. Cases of anaphylaxis and angioedema have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.

Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including AJOVY, in the postmarketing setting.

Monitor patients treated with AJOVY for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of AJOVY is warranted.

Raynaud’s Phenomenon: Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including AJOVY. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain.

AJOVY should be discontinued if signs or symptoms of Raynaud’s phenomenon develop. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

Adverse Reactions: The most common adverse reactions in clinical trials (≥5% and greater than placebo) were injection site reactions.

AJOVY is indicated for the preventive treatment of migraine in adults.

Please see the full Prescribing Information.

*Based on third-party USA data from IQVIA, top headache centers are defined as the top 50 treatment centers with the highest new preventive anti-CGRP prescription volume, that have 2 or more prescribers, 50 or more new prescriptions for anti-CGRPs, and 170 or more total prescriptions for anti-CGRPs (December 2023 – February 2024).

^†“Long-acting” and “lasting protection” defined as reduction in monthly average migraine or headache days (chronic migraine: 4.6 and 4.3 fewer headache days of at least moderate severity with monthly and quarterly dosing, respectively, vs 2.5 with placebo; episodic migraine: 3.7 and 3.4 fewer migraine days with monthly and quarterly dosing, respectively, vs 2.2 with placebo) measured over a 12-week period following a monthly 225 mg SC dose or quarterly 675 mg (225 mg x 3) SC dose.²

CGRP: calcitonin gene-related peptide; SC: subcutaneous.

References: 1. Data on file. Parsippany, NJ: Teva Pharmaceuticals USA, Inc. 2. AJOVY® (fremanezumab-vfrm) injection Current Prescribing Information. North Wales, PA: Teva Pharmaceuticals USA, Inc.

The long-acting anti-CGRP injection with lasting protection against migraine2†

The long-acting anti-CGRP injection with lasting protection against migraine^2†