Introducing Brekiya®:
The first and only DHE autoinjector1
For the acute treatment of migraine with or without aura and cluster
headaches in adults2
Brekiya autoinjector—where the proven power of DHE meets on‑the‑go convenience2,3
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Important Safety Information
Serious and/or life-threatening peripheral ischemia has been associated with the co-administration of dihydroergotamine with strong CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of Brekiya autoinjector with strong CYP3A4 inhibitors is contraindicated.
CONTRAINDICATIONS
Brekiya autoinjector is contraindicated in patients:
- With concomitant use of strong CYP3A4 inhibitors; with peripheral and central vasoconstrictors; and with other 5-HT1 agonists, ergotamine-containing or ergot-type medications within 24 hours.
- With ischemic heart disease or coronary artery vasospasm.
- With uncontrolled hypertension, peripheral arterial diseases, sepsis, following vascular surgery, or severe hepatic or renal impairment.
- Who have hypersensitivity to dihydroergotamine, ergot alkaloids, latex, or any of the ingredients in Brekiya autoinjector.
WARNINGS AND PRECAUTIONS
- Myocardial Ischemia and/or Infarction, Other Cardiac Adverse Reactions, and Fatalities: In patients with risk factors predictive of coronary artery disease, consider first dose administration under medical supervision with an electrocardiogram.
- Cerebrovascular Adverse Reactions and Fatalities: Cerebrovascular hemorrhage, subarachnoid hemorrhage, and stroke have been reported; discontinue Brekiya autoinjector if suspected.
- Other Vasospasm Related Adverse Reaction: Brekiya autoinjector may cause vasospasm or elevation in blood pressure. Discontinue if signs or symptoms of vasoconstriction develop.
- Medication Overuse Headache: Detoxification may be necessary.
- Preterm Labor: Advise pregnant women of the risk.
- Fibrotic Complication: Pleural and retroperitoneal fibrosis have been reported following prolonged daily use of dihydroergotamine mesylate. Do not exceed the Brekiya autoinjector dosing guidelines or use for chronic daily administration.
ADVERSE REACTIONS
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.
DOSAGE AND ADMINISTRATION
- For subcutaneous injection only.
- Recommended dosage is 1 mg administered subcutaneously as a single 1 mL autoinjector.
- Do not exceed 3 mg (3 doses) in a 24-hour period.
- Do not exceed 6 mg (6 doses) in a week.
- Prior to initiation, a cardiovascular evaluation is recommended.
DRUG INTERACTIONS
- Beta Blockers/Nicotine: May potentiate/provoke vasoconstriction.
- Selective Serotonin Reuptake Inhibitors: Weakness, hyperreflexia, and incoordination may occur with coadministration.
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm.
Lactation: Advise patients not to breastfeed during treatment with Brekiya autoinjector and for 3 days after the last dose.
INDICATIONS
Brekiya autoinjector 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 autoinjector is not indicated for the preventive treatment of migraine or for the management of hemiplegic migraine or migraine with brainstem aura.
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see the Brekiya autoinjector Full Prescribing Information, including Boxed Warning and Medication Guide.