Dihydroergotamine Mesylate

What it is and how it works

Mechanism of Action Dihydroergotamine binds with high affinity to 5-HT 1Dα and 5-HT 1Dβ receptors. The therapeutic activity of dihydroergotamine in migraine is generally attributed to the agonist effects at 5-HT 1D receptors.

Indications

is indicated for the acute treatment of migraine with or without aura in adults. ATZUMI is an ergotamine derivative indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use ATZUMI is not indicated for the preventive treatment of migraine or for the management of hemiplegic migraine or migraine with brainstem aura. Limitations of Use ATZUMI is not indicated for the preventive treatment of migraine. ATZUMI is not indicated for the management of hemiplegic migraine or migraine with brainstem aura.

Dosage and administration (summary)

is for nasal administration only. The recommended dose of ATZUMI is 5.2 mg, the contents of one nasal device, administered into one nostril. To administer a dose, the white air pump of the ATZUMI device must be squeezed three separate times into one nostril. The dose may be repeated, if needed, a minimum of 1 hour after the first dose. The maximum dose in a 24-hour period is 10.4 mg (two doses of ATZUMI 5.2 mg). The safety of taking more than 4 doses within a 7-day period or 12 doses within a 30-day period has not been established. Prior to initiation, a cardiovascular evaluation is recommended. Dosing Information ATZUMI is for nasal administration only.

Contraindications

is contraindicated in patients: with concomitant use of strong CYP3A4 inhibitors 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 with uncontrolled hypertension with peripheral arterial disease with sepsis following vascular surgery with severe hepatic impairment with severe renal impairment with kn…

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 electrocardiogram. Cerebrovascular Adverse Reactions and Fatalities: Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have been reported; discontinue ATZUMI if suspected. Other Vasospasm Related Adverse Reactions: ATZUMI may cause vasospasm or elevation in blood pressure. Discontinue if signs or symptoms of vasoconstriction develop.

Pregnancy

Pregnancy Risk Summary Available data from published literature indicate an increased risk of preterm delivery with dihydroergotamine, the active moiety in ATZUMI, use during pregnancy. Avoid use of ATZUMI during pregnancy .

Storage and supply

Storage and Handling Store ATZUMI at controlled room temperature, 20°C to 25°C (68°F to 77°F), with excursions allowed between 15°C to 30°C (59°F to 86°F). Store ATZUMI in its protective foil pouch until ready to use.

Source: Dihydroergotamine Mesylate (Atzumi) — US FDA prescribing information, 2026-06-22, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.