ATZUMI 5.2 mg/1

DIHYDROERGOTAMINE MESYLATE · POWDER · Satsuma Pharmaceuticals, Inc.

No Recall History

Plain English

ATZUMI is a powder containing dihydroergotamine mesylate at 5.2 mg/1, taken nasal. Manufactured by Satsuma Pharmaceuticals, Inc..

Key Facts

Brand Name: ATZUMI
Generic Name: DIHYDROERGOTAMINE MESYLATE
NDC Code (Product): 76978-101
Manufacturer: Satsuma Pharmaceuticals, Inc.
Strength: 5.2 mg/1
Dosage Form: POWDER
Route: NASAL
Marketing Status
Application #: NDA217901
Marketing Start: 04/30/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective329 reports

off label use311 reports

hyperhidrosis296 reports

nightmare282 reports

sedation282 reports

nausea272 reports

product use in unapproved indication236 reports

nephrolithiasis193 reports

migraine75 reports

treatment failure57 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ATZUMI 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. ( 1 ) 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. ( 1 ) 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 & Administration

2 DOSAGE AND ADMINISTRATION ATZUMI is for nasal administration only. ( 2.1 ) The recommended dose of ATZUMI is 5.2 mg, the contents of one nasal device, administered into one nostril. ( 2.1 ) To administer a dose, the white air pump of the ATZUMI device must be squeezed three separate times into one nostril. ( 2.1 ) 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). ( 2.1 ) 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. ( 2.1 ) Prior to initiation, a cardiovascular evaluation is recommended. ( 2.2 ) 2.1 Dosing Information ATZUMI is for nasal administration only. The recommended dose of ATZUMI is 5.2 mg (the contents of one nasal device) and is administered as a powdered medicine into one nostril [see Dosage and Administration (2.3) ]. 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 in a 7-day period or 12 doses within a 30-day period has not been established.…

Contraindications

4 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-HT 1 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) ] Concomitant use of strong CYP3A4 inhibitors. ( 4 ) Ischemic heart disease or coronary artery vasospasm ( 4 ) Uncontrolled hypertension, peripheral arter…

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 ATZUMI 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 effects could be additive with ATZUMI. Therefore, triptans and ATZUMI 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 ATZUMI 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 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) ] Most common adverse reactions (incidence > 1%) were rhinitis, nausea, altered sense of taste, application site reactions, dizziness, vomiting, somnolence, pharyngitis, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Satsuma Pharmaceuticals, Inc. at toll-free phone # 1-888-273-2480 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinic…

Frequently Asked Questions

What is ATZUMI used for?

ATZUMI contains DIHYDROERGOTAMINE MESYLATE. It is a powder taken nasal. Consult your doctor for specific uses.

Is ATZUMI a controlled substance?

ATZUMI is not classified as a controlled substance by the DEA.

What is the generic name for ATZUMI?

The generic name for ATZUMI is DIHYDROERGOTAMINE MESYLATE. There are 11 other brand versions of DIHYDROERGOTAMINE MESYLATE.

What is the NDC code for ATZUMI 5.2 mg/1?

The NDC (National Drug Code) for ATZUMI 5.2 mg/1 is 76978-101, listed by Satsuma Pharmaceuticals, Inc..

Product NDC

76978-101

Package NDC

76978-101-08

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