Brekiya

Pronunciation: breh-kee-yah
Generic name: dihydroergotamine mesylate
Dosage form: single-dose autoinjector injection, for subcutaneous use (1 mg/mL)
Drug class: Antimigraine agents

Medically reviewed by Carmen Pope, BPharm. Last updated on May 30, 2025.

What is Brekiya?

Brekiya is used to treat adults with acute migraine with or without aura or acute cluster headaches. It is a subcutaneous injection that is given at any point during a migraine or cluster headache attack. The dose may be repeated every 1 hour to a maximum dose of 3 mg (3 autoinjectors).

• Brekiya is not used to prevent migraine.
• Brekiya is not used to treat other types of headaches, such as hemiplegic migraines (that make you unable to move on one side of your body) or basilar migraines (a rare form of migraine with aura).

Brekiya works by binding to specific serotonin receptors (5-HT1D) in blood vessels and nerve pathways involved in migraine. When it activates these receptors, it causes blood vessels in the brain to constrict and blocks pain signals, effectively stopping migraine headaches. Brekiya belongs to the drug class called ergotamines.

Brekiya gained FDA approval on May 14, 2025. Dihydroergotamine was first approved as an injection in 1946.

Side effects

The most common but serious side effects of Brekiya are heart problems that may lead to death. These heart problems 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).

Symptoms of these heart problems include:

• numbness or tingling in your fingers and toes.
• muscle pain or cramps in your arms and legs.
• weakness in your legs.
• temporary speeding or slowing of your heart rate.
• swelling or itching.

Serious side effects and warnings

Brekiya carries a Boxed Warning for peripheral ischemia when used with certain medications that inhibit CYP3A4 liver enzymes.

Serious problems with blood circulation to your legs and feet (peripheral ischemia). Brekiya can cause peripheral ischemia when you take it with certain medicines known as CYP3A4 inhibitors. Peripheral ischemia may lead to a stroke and death. Stop taking Brekiya and get emergency medical help right away if you have any of the following symptoms:

• cramping and pain in your legs or hips
• feeling of heaviness or tightness in your leg muscles
• burning or aching pain in your feet or toes while resting
• numbness, tingling, or weakness in your legs
• cold feeling or color changes in 1 or both legs or feet
• slurred speech
• sudden weakness.

Brekiya can cause other following serious side effects:

• Heart attack and other heart problems. Heart problems may lead to death. Stop taking Brekiya and get emergency medical help right away if you have any of the following symptoms of a heart attack:
  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded.

Brekiya is not for people with risk factors for heart disease unless a heart exam is done and shows no problem.

• Stroke. Stop using Brekiya and get emergency medical help right away if you have any of the following symptoms of a stroke:
  • face drooping
  • unusual weakness or numbness
  • slurred speech.
• Changes in color or sensation in your fingers and toes (Raynaud’s syndrome).
• Stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include:
  • sudden or severe stomach pain
  • constipation or diarrhea
  • stomach pain after meals
  • bloody diarrhea
  • weight loss
  • fever
  • nausea or vomiting.
• Increased blood pressure.
• Medicine overuse headache. Some people who use too much Brekiya may make their headaches worse (medicine overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with Brekiya.
• Preterm labor.
• Tissue changes (fibrotic complications). Inflammation and fiber-like tissue that is not normal (fibrosis) can occur around the lungs and stomach.

It is not known if Brekiya is safe and effective in children.

Tell your healthcare provider if you have any side effect that bothers you or that do not go away. These are not all of the possible side effects of Brekiya. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Before taking

Do NOT use Brekiya if you:

• are taking medicines known as strong CYP3A4 inhibitors
• have heart problems or a history of heart problems
• have uncontrolled high blood pressure
• have narrowing of blood vessels in your legs, arms, stomach, or kidneys (peripheral vascular disease)
• have sepsis
• have had vascular surgery
• have severe liver problems
• have severe kidney problems
• are allergic to dihydroergotamine, ergot alkaloids, latex, or any of the ingredients in Brekiya.
• have taken any of the following medicines in the last 24 hours:
  • sumatriptan, almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, zolmitriptan, ergotamine or ergotamine-type medicines
  • medicines that constrict your blood vessels or raise your blood pressure.

Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take Brekiya with other medicines.

Before you use Brekiya, tell your healthcare provider about all of your medical conditions, including if you:

• have high blood pressure.
• have liver problems.
• have kidney problems.
• have risk factors for heart disease, such as have high cholesterol levels, smoke, are overweight, have diabetes, have a family history of heart disease
• are taking medicines known as strong CYP3A4 inhibitors.
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Brekiya may cause preterm labor and should not be used during pregnancy. Talk to your healthcare provider right away if you are pregnant or want to become pregnant.

Breastfeeding

Brekiya may reduce breast milk supply and pass into your breast milk, and may be harmful to your baby. Do not breastfeed your baby while taking Brekiya and for 3 days after you use Brekiya. Talk with your healthcare provider about the best way to feed your baby if you take Brekiya.

How should I use Brekiya?

Certain people should take their first dose of Brekiya in their healthcare provider’s office or in another medical setting. Ask your healthcare provider if you should take your first dose in a medical setting.

• Brekiya is for injection under the skin (subcutaneous) only.
• Brekiya should be injected into the skin of you upper middle thigh.
• Use Brekiya exactly as your healthcare provider tells you to use it.
• See the detailed Instructions for Use that comes with Brekiya for information about how to use Brekiya.

Each autoinjector contains 1 dose (1 mg) of Brekiya.

• Give your first injection at any time during your migraine or cluster headache, preferably at the start.
• If your headache comes back after the first complete dose, you may give yourself up to 2 more doses as needed.

Wait at least 1 hour between doses.

• Do not inject more than 3 doses (3 mg) of Brekiya in a 24-hour period or 6 doses (6 mg) in a 1-week (7-day) period.

Using Brekiya for 10 or more days in 1 month may make your headache worse. You should write down when you have headaches and when you take Brekiya so that you can talk with your healthcare provider about how Brekiya is working for you.

Dosing information

Adult dose of Brekiya for acute migraine or cluster headaches

Brekiya autoinjector is for subcutaneous (under the skin) injection only.

• Initial dose: 1 mg subcutaneously via a single 1 mL autoinjector.
  • Repeat as needed at 1-hour intervals.
• Maximum dose: 3 mg (3 doses) in 24 hours.
• Do not exceed 6 mg (6 doses) total in a week.  

What happens if I give too much Brekiya?

If you use too much Brekiya, call your healthcare provider or the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away

What other drugs will affect Brekiya?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your healthcare provider will decide if you can take Brekiya with your other medicines.

Especially tell your healthcare provider if you take:

• sumatriptan
• fluconazole
• propranolol or other medicines that can lower your heart rate
• ergot-type medicine
• grapefruit juice
• any medicines that can increase your blood pressure
• saquinavir
• zileuton
• selective serotonin reuptake inhibitors
• nefazodone
• nicotine

Do not take medicines known as strong CYP3A4 inhibitors, such as:

• ritonavir
• indinavir
• clarithromycin
• itraconazole
• nelfinavir
• erythromycin
• ketoconazole.

These are not all of the medicines that could affect how Brekiya works. Your healthcare provider can tell you if it is safe to take Brekiya with other medicines. Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take Brekiya with other medicines.

Storage

Store Brekiya at room temperature between 68°F to 77°F (20°C to 25°C).

Do not refrigerate or freeze Brekiya. Protect from light and keep it in the original pack until ready to use.

Keep out of the reach of children.

Ingredients

Active ingredient: dihydroergotamine mesylate, USP

Inactive ingredients: ethanol, glycerin, water for injection, methanesulfonic acid, or sodium hydroxide.

Available as 1 mg/mL dihydroergotamine mesylate as a 1 mL single-dose autoinjector for injection.

Who makes Brekiya?

Brekiya is manufactured by Amneal Pharmaceuticals Pvt. Ltd, located in Ahmedabad 382213, India. It is distributed by Amneal Specialty, a division of Amneal Pharmaceuticals LLC, with headquarters in Bridgewater, NJ 08807.

Frequently asked questions

• What are the new drugs for the treatment of migraine?

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer