Acute Headache Treatment Brekiya Launches in United States

Migraine and cluster headache autoinjector treatment Brekiya (dihydroergotamine mesylate) is now available by prescription through Walgreens Specialty Pharmacy and Sterling Specialty Pharmacy, according to a news release from its manufacturer, Amneal Pharmaceuticals, Inc.

Brekiya autoinjector is the first and only self-administered dihydroergotamine (DHE) autoinjector approved for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults. While the autoinjector was approved by the FDA in May 2025, dihydroergotamine has been used to treat patients in emergency rooms for decades. Dihydroergotamine’s initial U.S. approval was in 1946.

Commercially insured patients may pay as little as $40 for a carton of Brekiya, which includes 4 single-dose autoinjectors.

“We are excited to introduce the Brekiya autoinjector, making this innovative therapy broadly available to healthcare providers and patients,” Joe Renda, senior vice president, CCO, Specialty at Amneal, said in the news release. “As the first and only self-administered, ready-to-use DHE autoinjector, Brekiya offers patients the ability to treat debilitating attacks in a convenient way and avoid visits to the emergency room.”

Headache disorders are the fourth most common reason for emergency department visits in the United States, accounting for approximately 3% of visits.

Approximately 43 million Americans suffer from migraines, which are a type of primary headache disorder. Specific symptoms may differ from person to person and can include nausea, light sensitivity and fatigue, which can last hours or even days. Migraines can be broken up into subtypes, including migraine with typical aura, menstrual migraine or hemiplegic migraine. The most common type of migraine is migraine without aura. Migraine triggers include hormonal changes, certain foods and changes in weather.

Cluster headaches are separate from migraines and are rarer—approximately 1 in 1,000 suffer from cluster headaches. The main symptoms of a cluster headache include a sudden, excruciating burning or piercing sensation on one side of the head, which usually comes without warning. Attacks can last between 15 minutes and several hours, and some people may have multiple attacks a day, called cluster periods. Triggers for cluster headaches include alcohol consumption, strong odors and and changes in sleep patterns.

Sensory disturbances called auras can be present in both, although less commonly in cluster headaches. Auras can appear as flashing lights, shimmering spots, or blind spots or as sensory changes such as tingling or numbness.

Treatment options for migraines and cluster headaches are currently limited, which makes Brekiya an exciting new option for patients, the news release says.

Each Brekiya autoinjector contains a single 1-mg dose, administered subcutaneously into the middle of the thigh, according to the prescribing information. Patients may take up to two more doses if symptoms do not subside, making sure to wait an hour between injections. Patients should not exceed six doses in a week.

The most common and most serious adverse reactions from Brekiya are heart problems that include:

• temporary squeezing of arteries that supply the heart (coronary artery vasospasm)
• temporary decrease of blood flow to the heart (transient myocardial ischemia)
• heart rhythm problems (ventricular tachycardia and ventricular fibrillation).

Other potentially serious side effects include:

• Stroke
• Raynaud’s syndrome
• Stomach and intestinal problems
• Increased blood pressure
• Medicine and overuse headache

Brekiya should not be taken with CYP3A4 inhibitors such as ritonavir, nelfinavir, or indinavir or by people who are pregnant.

The Brekiya autoinjector does not require refrigeration, assembly or priming of the device.