The FDA has approved Brekiya® (dihydroergotamine mesylate) injection, the first and only autoinjector formulation of dihydroergotamine for the acute treatment of migraine with or without aura and cluster headaches in adults, according to Amneal Pharmaceuticals.
The single-dose autoinjector delivers 1 mg subcutaneously and is designed for self-administration. It does not require refrigeration, assembly, or priming, and is expected to be available for appropriate patients in the second half of 2025.
Brekiya contains the same medication used in hospitals, now available in a ready-to-use device. “Physicians are familiar with dihydroergotamine (DHE), which is an effective and well-established therapy that provides sustained relief for headaches. Our single-dose autoinjector represents an innovative therapeutic option for patients that allows for quick self-administration of the medication during these painful attacks without visiting the emergency room,” said Joe Renda, Senior Vice President and Chief Commercial Officer – Specialty at Amneal.
DHE may provide sustained relief for 24 to 72 hours and can be administered at any point during an attack. It may benefit patients who experience nausea, vomiting, gastroparesis, or an inadequate response to oral medications. The autoinjector offers a convenient alternative to intravenous administration in emergency settings, particularly for patients with limited treatment options.
Brekiya is contraindicated in patients taking strong CYP3A4 inhibitors (e.g., ritonavir, clarithromycin), those with coronary artery disease, uncontrolled hypertension, peripheral vascular disease, or severe hepatic or renal impairment. It should not be used by individuals with allergies to ergot alkaloids or formulation components, or by those who have recently used other vasoconstrictive agents or serotonergic migraine medications.
Serious adverse effects may include myocardial infarction, stroke, Raynaud phenomenon, gastrointestinal complications, hypertension, medication overuse headache, fibrosis, and preterm labor. Patients should not exceed three doses in 24 hours or six doses in seven days, and clinical monitoring is recommended for those with cardiovascular risk factors.
Brekiya is not indicated for hemiplegic or basilar migraine and is not approved for pediatric use.
Full prescribing information, including Boxed Warning, Medication Guide, and Instructions for Use, is available at Brekiya.com.
Source: Amneal Pharmaceuticals
