FDA

Dihydroergotamine auto-injector approved for migraine, cluster headache

May 22, 2025

FDA approved Brekiya (dihydroergotamine [DHE] mesylate) injection for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults.

According to a manufacturer press release, Brekiya autoinjector contains the same medication (DHE) used in hospitals, now in a ready-to-use device. Brekiya autoinjector doesn’t require refrigeration, assembly, or priming of the device. Patients can deliver one dose SC into the thigh. Brekiya may be beneficial for patients who respond inadequately to oral therapies, experience nausea or vomiting during attacks, have gastroparesis, or delay dosing until too late into the migraine attack.

Safety

DHE mesylate injection has been associated with serious (including fatal) cardiac events including coronary artery vasospasm, transient myocardial ischemia, MI, ventricular tachycardia, and ventricular fibrillation. Brekiya includes a Boxed Warning pertaining to serious and/or life-threatening peripheral ischemia associated with the co-administration of DHE with strong CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics.

Recommended dose

The recommended dosage of Brekiya is 1 mg SC via a single 1-mL autoinjector. The dose may be repeated, as needed, at 1-hour intervals to a total maximum of 3 mg (3 doses) in a 24-hour period. Don’t exceed 6 mg (6 doses) total in a week.

Sources:

Brekiya (dihydroergotamine mesylate) [package insert]. Amneal. https://documents.amneal.com/pi/brekiya.pdf Revised May 2025. Accessed May 20, 2025.

Amneal receives US FDA approval for Brekiya® (dihydroergotamine mesylate) injection for the acute treatment of migraine and cluster headaches in adults. [News release]. 2025. https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Receives-U-S--FDA-Approval-for-Brekiya-dihydroergotamine-mesylate-injection-for-the-Acute-Treatment-of-Migraine-and-Cluster-Headaches-in-Adults/default.aspx