Dihydroergotamine Mesylate (7 brand names, 4 dosage forms, 3 routes)
Available dosage forms: INJECTABLE, SPRAY, METERED, SOLUTION, POWDER.
Routes of administration: INJECTION, NASAL, SUBCUTANEOUS.
Brand Names
- ATZUMI
- BREKIYA (AUTOINJECTOR)
- D.H.E. 45
- DIHYDROERGOTAMINE MESYLATE
- EMBOLEX
- MIGRANAL
- TRUDHESA
Boxed Warning
Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with strong CYP3A4 inhibitors. 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 ATZUMI with strong CYP3A4 inhibitors is contraindicated [see Contraindications (4), Warnings and Precautions (5.1), and Drug Interactions (7.1)].
Indications and Usage
ATZUMI is indicated for the acute treatment of migraine with or without aura in adults.
Contraindications
ATZUMI 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 ergot alkaloids with recent use (i.e., within 24 hours) of other 5-HT1 agonists or 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)]
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 Adverse Cardiac Events, 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)] Local Irritation [see Warnings and Precautions (5.9)]
Mechanism of Action
Dihydroergotamine binds with high affinity to 5-HT1Dα and 5-HT1Dβ receptors. The therapeutic activity of dihydroergotamine in migraine is generally attributed to the agonist effects at 5-HT1D receptors.