Brekiya FDA Approval History

Last updated by Judith Stewart, BPharm on May 26, 2025.

FDA Approved: Yes (First approved May 14, 2025)
Brand name: Brekiya
Generic name: dihydroergotamine mesylate
Dosage form: Injection
Company: Amneal Pharmaceuticals LLC
Treatment for: Migraine, Cluster Headaches

Brekiya (dihydroergotamine mesylate) is a ready-to-use autoinjector presentation of the ergotamine derivative dihydroergotamine mesylate for the acute treatment of migraine and the acute treatment of cluster headaches.

• Brekiya is indicated for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults.
  Brekiya is not indicated for the preventive treatment of migraine or for the management of hemiplegic migraine or migraine with brainstem aura.
• Dihydroergotamine (DHE) is thought to work in the treatment of migraine through agonist effects at 5-HT_1D receptors.
• Dihydroergotamine mesylate is a well established migraine treatment with more than 70 years of therapeutic use, and has long been recommended in published migraine treatment guidelines as a first-line acute treatment option for migraine. It has been approved in injectable, liquid nasal spray, and nasal powder dosage forms under multiple brand names:
  - D.H.E. 45 (dihydroergotamine mesylate) injection (1946 - now discontinued; generic available)
  - Migranal (dihydroergotamine mesylate) nasal spray (1997)
  - Trudhesa (dihydroergotamine mesylate) nasal spray (2021)
  - Atzumi (dihydroergotamine mesylate) nasal powder (2025)
  - Brekiya (dihydroergotamine mesylate) injection (2025)
• Brekiya autoinjector provides patients with access to DHE in a convenient subcutaneous injection form that can be self-administered into the thigh. DHE is commonly administered by intravenous injection by health care professionals in emergency rooms, urgent care facilities, and headache clinics.
• Brekiya is administered subcutaneously as a single 1 mg dose into the middle of the thigh. 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, but no more than 6 mg (6 doses) total in one week.
• Brekiya comes with a Boxed Warning for serious and/or life-threatening peripheral ischemia associated with the coadministration of dihydroergotamine with strong CYP3A4 inhibitors. Warnings and precautions include myocardial Ischemia and/or infarction and other cardiac adverse reactions and fatalities; cerebrovascular adverse reactions and fatalities; other vasospasm related adverse reactions; medication overuse headache; risk of preterm labor in pregnant women; and fibrotic complications.
• Serious cardiac events (including fatal) that have been reported with dihydroergotamine mesylate injection use include coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, ventricular fibrillation.

Development timeline for Brekiya

Further information

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