FDA

Atzumi

Approved 30 Apr 2025NasalPowder

Indications

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.

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 arterial diseases, sepsis, following vascular surgery, or severe hepatic or renal impairment ( 4 ) Hypersensitivity to ergot alkaloids ( 4 ) Concomitant use of other 5-HT 1 agonists or ergotamine-containing or ergot-type medications within 24 hours ( 4 ) Concomitant use of peripheral and central vasoconstrictors ( 4 )

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. ( 5.2 ) Cerebrovascular Adverse Reactions and Fatalities: Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have been reported; discontinue ATZUMI if suspected. ( 5.3 ) Other Vasospasm Related Adverse Reactions: ATZUMI may cause vasospasm or elevation in blood pressure.

At a glance

Brand name: Atzumi
Active substance: dihydroergotamine mesylate
Route: Nasal
Dosage form: Powder
Applicant: Satsuma Pharms
Status: Prescription
FDA approval: 30 Apr 2025
Application: NDA217901-001

Indications

ATZUMI is not indicated for the management of hemiplegic migraine or migraine with brainstem aura.

Contraindications

Warnings and precautions

Pregnancy and breastfeeding

8.1Pregnancy 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 [see Warnings and Precautions (5.7) ] . Data collected over decades have shown no increased risk of major birth defects or miscarriage with the use of dihydroergotamine during pregnancy. In animal reproduction studies, adverse effects on development were observed following intranasal administration of dihydroergotamine mesylate during pregnancy (decreased fetal body weight and/or skeletal ossification) in rats and rabbits or during pregnancy and lactation in rats (decreased body weight and impaired reproductive function in the offspring) at doses that were not associated with maternal toxicity (see Data ) .

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The estimated rate of major birth defects (2.2% to 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. Data Animal Data Intranasal administration of dihydroergotamine mesylate to pregnant rats throughout the period of organogenesis resulted in decreased fetal body weight and/or skeletal ossification at doses of 0.16 mg/day and greater.

A no-effect level for adverse effects on embryofetal development was not identified in rats. Intranasal administration of dihydroergotamine mesylate to pregnant rabbits throughout organogenesis resulted in decreased skeletal ossification at 3.6 mg/day. The no-effect dose for adverse effects on embryofetal development in rabbits was 1.2 mg/day. Intranasal administration of dihydroergotamine mesylate to female rats throughout pregnancy and lactation resulted in decreased body weight and impaired reproductive function (decreased mating indices) in the offspring at doses of 0.16 mg/day or greater.

A no-effect dose for adverse effects on pre- and postnatal development in rats was not established. Effects on offspring development occurred at doses below those that produced evidence of significant maternal toxicity in these studies. Dihydroergotamine-induced intrauterine growth retardation has been attributed to reduced uteroplacental blood flow resulting from prolonged vasoconstriction of the uterine vessels and/or increased myometrial tone.

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.

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The studies described below were conducted with dihydroergotamine mesylate nasal spray; adverse reactions with ATZUMI nasal powder are expected to be similar to adverse reactions with dihydroergotamine mesylate nasal spray.

Adverse Reactions in Placebo-Controlled Trials with Dihydroergotamine Mesylate Nasal Spray [see Clinical Studies (14) ] Of the 1,796 patients and subjects treated with dihydroergotamine mesylate nasal spray doses 2 mg or less in U.S. and foreign clinical studies, 26 (1.4%) discontinued because of adverse events. The adverse events associated with discontinuation were, in decreasing order of frequency: rhinitis (13), dizziness (2), facial edema (2), and one patient each due to cold sweats, accidental trauma, depression, elective surgery, somnolence, allergy, vomiting, hypotension, and paraesthesia.

Table 1 summarizes the incidence rates of adverse reactions reported by at least 1% of patients who received dihydroergotamine mesylate nasal spray for the treatment of migraine during placebo-controlled, double-blind clinical studies and were more frequent than in those patients receiving placebo. The most commonly reported adverse reactions (greater than 1% of patients who received dihydroergotamine mesylate nasal spray) were rhinitis, nausea, altered sense of taste, application site reactions, dizziness, vomiting, somnolence, pharyngitis, and diarrhea.

In most instances these events were transient and self-limited and did not result in patient discontinuation from a study. Table 1 Adverse Reactions Reported by at Least 1% of the Dihydroergotamine Mesylate Nasal Spray Treated Patients and Occurred more Frequently than in the Placebo-Group in the Migraine Placebo-Controlled Trials Dihydroergotamine Mesylate Nasal Spray N=597 % Placebo N=631 % Respiratory System Rhinitis 26 7 Pharyngitis 3 1 Gastrointestinal System Nausea 10 4 Vomiting 4 1 Diarrhea 2 <1 Special Senses, Other Altered Sense of Taste 8 1 Application Site Application Site Reaction 6 2 Central and Peripheral Nervous System Dizziness 4 2 Somnolence 3 2 Body as a Whole, General Hot Flashes 1 <1 Asthenia 1 0 Musculoskeletal System Stiffness 1 <1 Adverse Reactions in Studies with ATZUMI An open-label study in adults was conducted to evaluate the safety and tolerability of ATZUMI, with repeated use of ATZUMI over the course of 6 to 12 months.

A total of 344 patients with migraine received at least one dose of ATZUMI. One hundred and eighty-eight patients treated on average at least two migraines per month for at least 6 months, and 86 patients treated at least two migraines per month for at least one year. Of the patients who received at least one dose of ATZUMI, 99 (29%) experienced local irritative symptoms. Of these, the most common local irritative symptoms (at least 5% of patients) were nasal discomfort, altered taste, nasal congestion, and nasopharyngitis [see Warnings and Precautions (5.9) ] .

The most common adverse reaction resulting in discontinuation in the long-term safety study was nasal discomfort (1.5%).

6.2Postmarketing Experience

The following adverse reactions have been identified during postapproval use of dihydroergotamine. 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 drug exposure: Vasospasm, paresthesia, hypertension, dizziness, anxiety, dyspnea, headache, flushing, diarrhea, rash, increased sweating, and pleural and retroperitoneal fibrosis after long-term use of dihydroergotamine.

Cases of myocardial infarction and stroke have been reported following the use of dihydroergotamine [see Warnings and Precautions (5.2) ] .

Atzumi

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

Atzumi

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

5.1Peripheral Ischemia Following Coadministration with Strong CYP3A4 Inhibitors

5.2Myocardial

5.3Cerebrovascular Adverse Reactions and Fatalities

5.4Other Vasospasm Related Adverse Reactions

5.5Increase in Blood Pressure

5.6Medication Overuse Headache Overuse

5.8Fibrotic Complications

5.9Local Irritation

Interactions

7.1CYP3A4 Inhibitors

7.2Triptans Triptans

7.3Beta Blockers

7.4Vasoconstrictors

7.5Nicotine

7.6Selective Serotonin Reuptake Inhibitors

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Official product information