Home › NDC Lookup › Ingredients › Dihydroergotamine Mesylate › 76978-0101-11
ATZUMI DIHYDROERGOTAMINE MESYLATE 5.2 mg Powder, 1 bottle — NDC 76978-0101-11 package photo

ATZUMI DIHYDROERGOTAMINE MESYLATE 5.2 mg Powder, 1 bottle

by Satsuma Pharmaceuticals, Inc. · 1 BOTTLE, UNIT-DOSE in 1 CARTON (76978-101-11) / 1 POWDER in 1 BOTTLE, UNIT-DOSE
NDC 76978-0101-11
🏷️ FDA NDC (as labeled) 76978-101-11 billing pads the product segment with a zero
This package
Contains1 bottle Pack sizes2 compare ↓
Also comes in: 8 bottles 76978-0101-08
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Dihydroergotamine Mesylate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Nov 22, 2024 — Discoloration (Provepharm Inc.) · FDA recall D-0150-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 76978-101-11
Product NDC 76978-101
11-digit billing NDC 76978010111
RxCUI 2714187, 2714192
UNII 81AXN7R2QT
Application # NDA217901
SPL Set ID 0982a44a-dc0c-75c0-e063-6394a90a6d6c
Established class (EPC) Ergotamine Derivative
Chemical class Ergotamines
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-04-30
Route NASAL
Dosage form POWDER
Substance DIHYDROERGOTAMINE MESYLATE
Why two NDCs? The FDA registers this code as 76978-101-11 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 76978-0101-11. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Ergotamine Derivative class.

Pharmacologic class Ergotamine Derivative
Drug family (ATC) Ergot alkaloids
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerSatsuma Pharmaceuticals, Inc.
Application holderSATSUMA PHARMACEUTICALS INC
FDA applicationNDA217901 (NDA)
Labeler code76978
First marketedApr 2025
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • It's used to treat a migraine attack that's already started — with or without the aura (visual disturbances or other sensory changes that can come before the headache). It works be...
  • What exactly is dihydroergotamine nasal spray used for?
  • That depends on which product you have. If you're using Atzumi (the nasal powder), you insert the blue nozzle into one nostril and squeeze the white air pump three separate times w...
  • The most common ones are nasal irritation, a runny or stuffy nose, an odd or altered taste, nausea, and dizziness. These are usually mild and go away on their own within a few hour...
📖 Read our full Dihydroergotamine Nasal Spray guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 8 bottles
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Atzumi 5.2 mgthis 76978-0101-11 Satsuma 1 bottle — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2025
First FDA approval
Apr 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2041
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Oct 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 30, 2025 RLD RS ⏳ ~15.1 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11872314 — drug product
US 12102754 — drug product
US 10792253 — drug product
US 12594273 — drug product
US 10758532 — drug product
US 12263162 — drug product
US 11744967 — drug product
Exclusivity NP
2025 2027 2029 2031 2033 2035 2037 2039 2041
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (7)
PatentTypeUse codeExpires
US 11872314 ↗ Drug product — Aug 4, 2037
US 12102754 ↗ Drug product — Oct 12, 2041
US 10792253 ↗ Drug product — Aug 4, 2037
US 12594273 ↗ Drug product — Sep 24, 2033
US 10758532 ↗ Drug product — Dec 11, 2039
US 12263162 ↗ Drug product — Dec 11, 2039
US 11744967 ↗ Drug product — Oct 12, 2041
FDA exclusivity
CodeWhat it grantsExpires
NPNew ProductApr 30, 2028
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Oct 2041 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Dihydroergotamine Mesylate (matched by generic name) — the program that covers self-administered drugs. 7 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Dihydroergotamine Mesylate. CMS lists 4 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.55M
Claims incl. refills
3.5K
Beneficiaries
1.5K
Spend / beneficiary
$1,672.11
Spend / claim
$729.25
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for ATZUMI (this brand).

Top reported reactions

Hyperhidrosis323
Nightmare308
Sedation308
Nausea306
Nephrolithiasis222
Migraine77
Treatment Failure57

Age at onset

Child1
Adolescent2
Adult88
Elderly6

Reporter sex

766 reports
Male · 48%
Female · 52%
Unknown · 0%

Serious outcomes

Hospitalization137
Life-threatening14
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 124 18
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
76978-0101-08 8 BOTTLE, UNIT-DOSE in 1 CARTON (76978-101-08) / 1 POWDER in 1 BOTTLE, UNIT-DOSE 2025-04-30 Active
76978-0101-11 You're viewing this 1 BOTTLE, UNIT-DOSE in 1 CARTON (76978-101-11) / 1 POWDER in 1 BOTTLE, UNIT-DOSE 2025-04-30 Active

Pack size FAQ

What quantity is in NDC 76978-0101-11?
NDC 76978-0101-11 contains 1 bottle — 1 bottle, unit-dose in 1 carton / 1 powder in 1 bottle, unit-dose.
What is the difference between NDC 76978-0101-11 and NDC 76978-0101-08?
Both are ATZUMI DIHYDROERGOTAMINE MESYLATE 5.2 mg Powder — the drug itself is identical. NDC 76978-0101-11 is the 1 bottle package, while NDC 76978-0101-08 is the 8 bottles package.
What NDC number is used to bill for this package of ATZUMI DIHYDROERGOTAMINE MESYLATE 5.2 mg Powder?
Bill NDC 76978-0101-11 — the 11-digit billing format is 76978010111. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 76978-101-11, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 76978-0101-11, written without dashes as 76978010111. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 76978-0101-11, the first segment (76978) is the labeler code FDA assigned to Satsuma Pharmaceuticals, Inc.; the middle segment (0101) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (11) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Satsuma Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 8 bottles (76978-0101-08). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Satsuma Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning 151 words ▾

WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH STRONG CYP3A4 INHIBITORS 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) ].

WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH STRONG CYP3A4 INHIBITORS See full prescribing information for complete 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. ( 4 , 5.1 , 7.1 )

🎯 Indications and Usage 96 words ▾

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 and Administration ~2 min read ▾

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 )

2.1Dosing 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.

2.2Assessment Prior to First Dose Prior to initiation of ATZUMI, a cardiovascular evaluation is recommended [see Warnings and Precautions (5.2) ] . For patients with risk factors predictive of coronary artery disease who are determined to have a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of ATZUMI take place in the setting of an equipped healthcare facility.

2.3Administration Instructions Priming is not required. To administer a dose of ATZUMI, remove the round blue tab from the blue nozzle, and insert the blue nozzle into one nostril. Squeeze the white air pump 3 separate times into 1 nostril while inhaling.

Allow the white air pump to expand back to its original shape between squeezes [see Instructions for Use ]. Fast, complete, pulse-like squeezes are needed to deliver the complete dose. Do not squeeze slowly, partially or with any hesitation.

💊 Dosage Forms and Strengths 26 words ▾

3 DOSAGE FORMS AND STRENGTHS Nasal Powder: 5.2 mg dihydroergotamine as a white powder in a single-dose nasal device. Nasal powder: 5.2 mg ( 3 )

⛔ Contraindications 215 words ▾

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 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 Cautions ~2 min read ▾

5 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.

Discontinue if signs or symptoms of vasoconstriction develop. ( 5.4 , 5.5 ) Medication Overuse Headache: Detoxification may be necessary. ( 5.6 ) Preterm Labor: Advise pregnant women of the risk.

( 5.7 , 8.1 ) Fibrotic Complications: Pleural and retroperitoneal fibrosis have been reported following prolonged daily use of dihydroergotamine. Administration of ATZUMI should not exceed the dosing guidelines or be used for chronic daily administration. ( 5.8 ) Local Irritation: If severe local irritation occurs for no other attributable reason, suspend ATZUMI until resolution.

( 5.9 )

5.1Peripheral Ischemia Following Coadministration with Strong CYP3A4 Inhibitors Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with strong CYP3A4 inhibitors, including protease inhibitors, macrolide antibiotics, and antifungals. 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) and Drug Interactions (7.1) ] .

5.2Myocardial Ischemia and/or Infarction, Other Cardiac Adverse Reactions, and Fatalities The potential for cardiac adverse reactions exists with ATZUMI treatment. Serious adverse cardiac events, including some that have been fatal, have occurred following use of dihydroergotamine. These events have included acute myocardial infarction, life-threatening disturbances of cardiac rhythm (e.g., ventricular tachycardia and ventricular fibrillation), coronary artery vasospasm, and transient myocardial ischemia.

Prior to initiation of ATZUMI, a cardiovascular evaluation is recommended to determine if the patient is free of coronary artery and ischemic myocardial disease or other significant underlying cardiovascular disease. If, during the cardiovascular evaluation, the patient's medical history (including risk factors), or electrocardiographic investigation, findings are consistent with coronary artery vasospasm or myocardial ischemia, ATZUMI should not be administered [see Contraindications (4) ] . For patients with risk factors predictive of coronary artery disease (e.g., hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of coronary artery disease, females who are surgically or physiologically postmenopausal, or males who are over 40 years of age) who are determined to have a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of ATZUMI take place in the setting of an equipped healthcare facility, unless the patient has previously received dihydroergotamine.

During the interval immediately following the first use of ATZUMI, an electrocardiogram is recommended in those patients with risk factors because ischemia can occur in the absence of clinical symptoms.

5.3Cerebrovascular Adverse Reactions and Fatalities The potential for adverse cerebrovascular adverse reactions exists with ATZUMI treatment. Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with dihydroergotamine; and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the dihydroergotamine having been administered in the inco…

🤒 Adverse Reactions ~3 min read ▾

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.

6.1Clinical 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 m…

🔄 Drug Interactions ~1 min read ▾

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 )

7.1CYP3A4 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.

7.2Triptans 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) ] .

7.3Beta Blockers There have been reports that propranolol may potentiate the vasoconstrictive action of ergotamine by blocking the vasodilating property of epinephrine.

7.4Vasoconstrictors ATZUMI is contraindicated for use with peripheral and central vasoconstrictors because the combination may cause synergistic elevation of blood pressure [see Warnings and Precautions (5.5) ] .

7.5Nicotine Nicotine may provoke vasoconstriction in some patients, predisposing to a greater ischemic response to ergot therapy [see Warnings and Precautions (5.2 , 5.4) ] .

7.6Selective Serotonin Reuptake Inhibitors Weakness, hyperreflexia, and incoordination have been reported rarely when 5-HT 1 agonists have been co-administered with selective serotonin reuptake inhibitors (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline).

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) Lactation: Advise not to use during breastfeeding. ( 8.2 )

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.

8.2Lactation Risk Summary There are no data on the presence of dihydroergotamine in human milk; however, ergotamine, a related drug, is present in human milk. There are reports of diarrhea, vomiting, weak pulse, and unstable blood pressure in breastfed infants exposed to ergotamine. ATZUMI may reduce milk supply because it may decrease prolactin levels.

Because of the potential for reduced milk supply and serious adverse events in the breastfed infant, including diarrhea, vomiting, weak pulse, and unstable blood pressure, advise patients not to breastfeed during treatment with ATZUMI and for 3 days after the last dose. Breast milk supply during this time should be pumped and discarded.

8.4Pediatric Use The safety and effectiveness of ATZUMI have not been established in pediatric patients.

8.5Geriatric Use Clinical studies of ATZUMI and other dihydroergotamine products did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. In general, dose selection for an e…

🤰 Pregnancy ~2 min read ▾

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.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of ATZUMI have not been established in pediatric patients.

🧓 Geriatric Use 71 words ▾

8.5Geriatric Use Clinical studies of ATZUMI and other dihydroergotamine products did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

🆘 Overdosage 182 words ▾

10 OVERDOSAGE

10.1Symptoms Excessive doses of dihydroergotamine may result in peripheral signs and symptoms of ergotism. In general, the symptoms of an acute ATZUMI overdose may be similar to those of an ergotamine overdose, although there may be less pronounced nausea and vomiting with ATZUMI. The symptoms of an ergotamine overdose include the following: numbness, tingling, pain, and cyanosis of the extremities associated with diminished or absent peripheral pulses; respiratory depression; an increase and/or decrease in blood pressure, usually in that order; confusion, delirium, convulsions, and coma; and/or some degree of nausea, vomiting, and abdominal pain.

In laboratory animals, dihydroergotamine mesylate was lethal when given at intravenous doses of 44 mg/kg in mice, 130 mg/kg in rats, and 37 mg/kg in rabbits.

10.2Treatment Treatment of an overdose of ATZUMI should consist of discontinuation of the drug, general supportive measures including monitoring of vital signs, and observation of the clinical status of the patient for at least 24 hours, or while symptoms or signs persist. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism 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.

12.2Pharmacodynamics Significant elevation in blood pressure has been reported in patients treated with dihydroergotamine with and without a history of hypertension [see Warnings and Precautions (5.5) ] . Dihydroergotamine possesses oxytocic properties [see Warnings and Precautions (5.7) ] .

12.3Pharmacokinetics Absorption Following ATZUMI administration, the mean maximum plasma concentration was 2.1 ng/mL, and the median time from dosing to maximum plasma concentration was approximately 0.5 hours. Distribution Dihydroergotamine is 93% plasma protein bound. The apparent steady-state volume of distribution is approximately 800 liters.

Elimination The mean apparent half-life of dihydroergotamine following nasal administration of ATZUMI in healthy subjects is approximately 13 hours. Metabolism Four dihydroergotamine mesylate metabolites have been identified in human plasma following oral administration. The major metabolite, 8'-β-hydroxydihydroergotamine, exhibits affinity equivalent to its parent for adrenergic and 5-HT 1 receptors and demonstrates equivalent potency in several venoconstrictor activity models, in vivo and in vitro.

The other metabolites, (i.e., dihydrolysergic acid, dihydrolysergic amide) and a metabolite formed by oxidative opening of the proline ring are of minor importance. Following nasal administration of ATZUMI, the 8'-β-hydroxydihydroergotamine metabolite plasma AUC was approximately 16% of the plasma AUC of dihydroergotamine, and the mean C max (5.7% of parent) was below the minimal concentrations required for receptor binding for adrenergic and 5-HT 1 receptors. Excretion The major excretory route of dihydroergotamine is via the bile in the feces.

The total body clearance following ATZUMI administration is

1.5L/min which reflects mainly hepatic clearance. The renal clearance (0.1 L/min) is unaffected by the route of dihydroergotamine administration based on other dihydroergotamine products. Specific Populations No studies have been conducted on the effect of renal or hepatic impairment, gender, race, ethnicity, or pregnancy on dihydroergotamine pharmacokinetics [see Contraindications (4) , Use in Specific Populations (8.1) ] .

Drug Interaction Studies CYP3A4 Inhibitors In a drug interaction study, administration of ATZUMI with itraconazole increased dihydroergotamine plasma exposure by 14% for C max and 19% for AUC while the plasma exposures (C max and AUC 0-inf ) of 8'-β-hydroxy dihydroergotamine (8'-OH-DHE, active metabolite) were increased by approximately 4-fold and 3-fold, respectively [see Contraindications (4) , Warnings and Precautions (5.1) , Drug Interactions (7.1) ] . Other Drugs The pharmacokinetics of dihydroergotamine did not appear to be significantly affected by the concomitant use of a local vasoconstrictor.

Multiple oral doses of the β-adrenoceptor antagonist propranolol, used for preventive treatment of migraine, had no significant influence on the C max , T max or AUC of dihydroergotamine doses up to 4 mg [see Drug Interactions (7.3) ]. The effect of oral contraceptives on the pharmacokinetics of dihydroergotamine has not been studied.

🧬 Mechanism of Action 34 words ▾

12.1Mechanism 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.

📦 How Supplied / Storage and Handling 84 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied ATZUMI (dihydroergotamine) nasal powder is supplied in a single-dose nasal device with white powder containing 5.2 mg of dihydroergotamine. ATZUMI is available in a carton of 8 nasal devices each individually packaged in a protective foil pouch (NDC 76978-101-08).

16.2Storage 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.

📦 Storage and Handling 37 words ▾

16.2Storage 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.

📋 Description 130 words ▾

11 DESCRIPTION ATZUMI contains dihydroergotamine, an ergotamine derivative, as the mesylate salt. Dihydroergotamine mesylate is a white or almost white crystalline powder. It is slightly soluble in water and chloroform and sparingly soluble in methanol.

The chemical designation for dihydroergotamine mesylate is (6aR,9R,10aR)-N-[(2R,5S,10aS,10bS)-5-benzyl-10b-hydroxy-2-methyl-3,6-dioxo-octahydro-8H-oxazolo[3,2-α]pyrrolo[2,1-c]pyrazin-2-yl]-7-methyl- 4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinoline-9-carboxamide methanesulphonate. The empirical formula is C 33 H 37 N 5 O 5 ∙ CH 4 O 3 S. The molecular weight is 679.80, and it has the following structure: ATZUMI contains dihydroergotamine 5.2 mg (equivalent to 6.0 mg dihydroergotamine mesylate).

ATZUMI nasal powder is a drug-device combination product consisting of a powder prefilled in a single-dose delivery device for nasal administration into one nostril. ATZUMI does not need to be assembled or primed before use. Inactive ingredients are hypromellose, mannitol, and microcrystalline cellulose.

Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Serious and/or Life-Threatening Reactions with Coadministration of CYP3A4 Inhibitors Inform patients that serious and/or life-threatening peripheral ischemia (cerebral ischemia and/or ischemia of the extremities) has been associated with the coadministration of dihydroergotamine and strong CYP3A4 inhibitors, such as macrolide antibiotics and protease inhibitors [see Contraindications (4) , Warnings and Precautions (5.1) , and Drug Interactions (7.1) ].

Myocardial Ischemia and/or Infarction, Other Cardiac Events, Cerebrovascular Events, and Fatalities Inform patients of the risk for serious cardiac, cerebrovascular, and other vasospasm related events. Advise patients to notify their healthcare provider if they develop any risk factors or symptoms while taking ATZUMI. Inform patients that nicotine may provoke vasoconstriction predisposing to a greater ischemic response [see Warnings and Precautions (5.2 , 5.3 , 5.4) ] .

Increase in Blood Pressure Inform patients of the risk for significant elevation in blood pressure [see Warnings and Precautions (5.5) ] . Medication Overuse Headache Inform patients that use of drugs to treat migraine attacks for 10 or more days per month may lead to an exacerbation of headache, and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions (5.6) ]. Local Irritation Advise patients to notify their healthcare provider if they have bothersome local irritation [see Warning and Precautions (5.9) ].

Drug Interactions Advise patients to inform their healthcare providers if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions [see Drug Interactions (7) ] . Pregnancy Advise patients of the risk for preterm birth. Advise women to inform their healthcare provider if they are pregnant or intend to become pregnant [see Warnings and Precautions (5.7) , Use in Specific Populations (8.1) ] .

Lactation Advise patients not to breastfeed during treatment with ATZUMI [see Use In Specific Populations (8.2) ] . Administration Instructions Instruct patients not to squeeze ATZUMI before inserting it into the nostril because priming is not required. Inform patients that they will need to squeeze the air pump on the ATZUMI device three separate times into one nostril to give a dose.

Instruct the patient to squeeze while inhaling, release to allow the air pump to expand back to its original shape, then repeat two more times [see Instructions for Use ]. Tell patients to use fast, complete, pulse-like squeezes to deliver their dose. [see Dosage and Administration (2.3) ].

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE ATZUMI™ (at zoo' mee) (dihydroergotamine) nasal powder This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 04/2025 What is the most important information I should know about ATZUMI?

ATZUMI can cause serious side effects, including: Serious problems with blood circulation to your legs and feet (peripheral ischemia). ATZUMI can cause peripheral ischemia when you take it with certain medicines known as CYP3A4 inhibitors. Peripheral ischemia may lead to a stroke and death.

Stop taking ATZUMI and get emergency medical help right away if you have any of the following symptoms: cramping and pain in your legs or hips feeling of heaviness or tightness in your leg muscles burning or aching pain in your feet or toes while resting numbness, tingling, or weakness in your legs cold feeling or color changes in 1 or both legs or feet slurred speech sudden weakness Do not take medicines known as strong CYP3A4 inhibitors, such as: ritonavir nelfinavir erythromycin clarithromycin ketoconazole itraconazole These are not all of the medicines that could affect how ATZUMI works.

Your healthcare provider can tell you if it is safe to take ATZUMI with other medicines. What is ATZUMI? ATZUMI is a prescription medicine used for the acute treatment of migraine with or without aura in adults.

ATZUMI is not used to prevent migraine. ATZUMI is not used to treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines. It is not known if ATZUMI is safe and effective in children.

Who should not take ATZUMI? Do not take ATZUMI if you: are taking medicines known as strong CYP3A4 inhibitors. have heart problems or a history of heart problems. have uncontrolled high blood pressure. have narrowing of blood vessels in your legs, arms, stomach, or kidneys (peripheral vascular disease). have sepsis. have had vascular surgery. have severe liver problems. have severe kidney problems. are allergic to dihydroergotamine, ergot alkaloids, or any of the ingredients in ATZUMI. See the end of this Medication Guide for a complete list of ingredients in ATZUMI. have taken any of the following medicines in the last 24 hours: sumatriptan almotriptan eletriptan frovatriptan naratriptan rizatriptan zolmitriptan ergotamine or ergotamine-type medicines have taken any medicines that constrict your blood vessels or raise your blood pressure.

Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take ATZUMI with other medicines. Before you take ATZUMI, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure. have liver problems. have kidney problems. have risk factors for heart disease.

You have a higher risk for heart disease if you: have high blood pressure have high cholesterol levels smoke are overweight have diabetes have a family history of heart disease are taking medicines known as strong CYP3A4 inhibitors. are pregnant or plan to become pregnant. ATZUMI may cause preterm labor. ATZUMI should be avoided during pregnancy.

Talk to your healthcare provider right away if you are pregnant or want to become pregnant. are breastfeeding or plan to breastfeed. ATZUMI may reduce breast milk supply and pass into your breast milk. ATZUMI may be harmful to your baby.

Do not breastfeed your baby while taking ATZUMI and for 3 days after you use ATZUMI. Talk with your healthcare provider about the best way to feed your baby if you take ATZUMI. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Your healthcare provider will decide if you can take ATZUMI with your other medicines. How should I take ATZUMI? ATZUMI is for nasal use only (use in the nose).

Certain people should take their first dose of AT…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 76973-0071-08 · GG 76986-0001-01 · Guangdong →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.