BREKIYA 1 mg/mL
Dihydroergotamine Mesylate · INJECTION · Amneal Pharmaceuticals LLC
BREKIYA is a injection containing dihydroergotamine mesylate at 1 mg/mL, taken subcutaneous. Manufactured by Amneal Pharmaceuticals LLC.
Key Facts
- Brand Name
- BREKIYA
- Generic Name
- Dihydroergotamine Mesylate
- NDC Code (Product)
64896-509- Manufacturer
- Amneal Pharmaceuticals LLC
- Strength
- 1 mg/mL
- Dosage Form
- INJECTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- NDA215400
- Marketing Start
- 05/16/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE BREKIYA is indicated for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults. Limitations of Use BREKIYA is not indicated for the preventive treatment of migraine. BREKIYA is not indicated for the management of hemiplegic migraine or migraine with brainstem aura. BREKIYA is an ergotamine derivative indicated for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults. ( 1 ) Limitations of Use BREKIYA is not indicated for the preventive treatment of migraine or for the management of hemiplegic migraine or migraine with brainstem aura. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For subcutaneous injection only. ( 2.1 ) Recommended dosage is 1 mg administered subcutaneously as a single 1 mL autoinjector. ( 2.1 ) Do not exceed 3 mg (3 doses) in a 24-hour period. ( 2.1 ) Do not exceed 6 mg (6 doses) in a week. ( 2.1 ) Prior to initiation, a cardiovascular evaluation is recommended. ( 2.2 ) 2.1 Recommended Dosage BREKIYA autoinjector is for subcutaneous injection only. The recommended dose of BREKIYA is 1 mg administered subcutaneously 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. Do not exceed 6 mg (6 doses) total in a week. 2.2 Assessment Prior to First Dose Prior to initiation of BREKIYA, a cardiovascular evaluation is recommended [see Warnings and Precautions (5.3) ] . For patients with risk factors predictive of coronary artery disease who are determined to have a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of BREKIYA take place in the setting of an equipped healthcare facility. 2.3 Important Administration Instructions See the “Instructions for Use” for detailed steps…
Contraindications
4 CONTRAINDICATIONS BREKIYA is contraindicated in patients: with concomitant use of strong CYP3A4 inhibitors [see Warnings and Precautions (5.1) and Drug Interactions (7.1) ] with ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, or documented silent ischemia) or patients who have clinical symptoms or findings consistent with coronary artery vasospasm, including Prinzmetal's variant angina [see Warnings and Precautions (5.4) ] with uncontrolled hypertension [see Warnings and Precautions (5.5) ] with peripheral arterial disease with sepsis following vascular surgery with severe hepatic impairment with severe renal impairment with known hypersensitivity to dihydroergotamine, ergot alkaloids, latex, or any of the ingredients in BREKIYA [see Warnings and Precautions (5.9) ] with recent use (i.e., within 24 hours) of other 5-HT 1 agonists, ergotamine-containing or ergot-type medications [see Drug Interactions (7.2) ] with concomitant use of peripheral and central vasoconstrictors because the combination may result in additive or synergistic elevation of blood pressure [see Warnings and Precautions (5.5) ] Concomitant use of strong CYP3A4 inhibitors ( 4 ) I…
Drug Interactions
7 DRUG INTERACTIONS Beta Blockers/Nicotine: May potentiate/provoke vasoconstriction. ( 7.3 , 7.5 ) Selective Serotonin Reuptake Inhibitors: Weakness, hyperreflexia, and incoordination may occur with coadministration. ( 7.6 ) 7.1 CYP3A4 Inhibitors There have been rare reports of serious adverse events in connection with the coadministration of intravenous administration of dihydroergotamine and strong CYP3A4 inhibitors resulting in vasospasm that led to cerebral ischemia and/or ischemia of the extremities [see Warnings and Precautions (5.1) ]. The use of strong CYP3A4 inhibitors with BREKIYA is contraindicated [see Contraindications (4) ]. Administer moderate CYP3A4 inhibitors with caution. 7.2 Triptans Triptans (serotonin [5-HT 1B/1D receptor agonists) have been reported to cause coronary artery vasospasm, and its effect could be additive with BREKIYA. Therefore, triptans and BREKIYA should not be taken within 24 hours of each other [see Contraindications (4) ]. 7.3 Beta Blockers There have been reports that propranolol may potentiate the vasoconstrictive action of ergotamine by blocking the vasodilating property of epinephrine. 7.4 Vasoconstrictors BREKIYA is contraindicated for u…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Peripheral Ischemia Following Coadministration with Strong CYP3A4 Inhibitors [see Boxed Warning and Warnings and Precautions (5.1) ] Myocardial Ischemia and/or Infarction, Other Cardiac Adverse Reactions, and Fatalities [see Warnings and Precautions (5.2) ] Cerebrovascular Adverse Reactions and Fatalities [see Warnings and Precautions (5.3) ] Other Vasospasm Related Adverse Reactions [see Warnings and Precautions (5.4) ] Increase in Blood Pressure [see Warnings and Precautions (5.5) ] Medication Overuse Headache [see Warnings and Precautions (5.6) ] Preterm Labor [see Warnings and Precautions (5.7) ] Fibrotic Complications [see Warnings and Precautions (5.8) ] Hypersensitivity [see Warnings and Precautions (5.9) ] The following adverse reactions associated with the use of dihydroergotamine were identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug exposure. Serious cardiac…
Frequently Asked Questions
What is BREKIYA used for?
BREKIYA contains Dihydroergotamine Mesylate. It is a injection taken subcutaneous. Consult your doctor for specific uses.
Is BREKIYA a controlled substance?
BREKIYA is not classified as a controlled substance by the DEA.
What is the generic name for BREKIYA?
The generic name for BREKIYA is Dihydroergotamine Mesylate. There are 11 other brand versions of Dihydroergotamine Mesylate.
What is the NDC code for BREKIYA 1 mg/mL?
The NDC (National Drug Code) for BREKIYA 1 mg/mL is 64896-509, listed by Amneal Pharmaceuticals LLC.
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)