Atzumi

Atzumi is used to treat migraine with or without aura in adults. It is a nasal powder, and one dose is administered into one nostril as soon as possible after migraine symptoms start.

• Atzumi will only treat a migraine that has already begun. It will not prevent migraines or reduce their frequency.

Atzumi (dihydroergotamine nasal powder) gained FDA approval on April 30, 2025. There is no generic.

Atzumi (dihydroergotamine) works via multiple mechanisms to treat migraines. It binds to and activates serotonin receptors (5-HT1Dα and 5-HT1Dβ) to constrict cranial blood vessels, inhibit inflammation, block pain transmission in the trigeminal nerve pathway, and disrupt the neurological cascade that causes migraine symptoms.

Atzumi belongs to the drug class called ergotamines.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

• Before you use Atzumi, your healthcare provider should conduct a thorough cardiovascular evaluation and show you how to use the device.
• You should use Atzumi as soon as your headache begins, but it may be given at any time during the migraine episode.

Each Atzumi nasal powder device contains one dose.

• Do not squeeze the device before inserting it into your nostril because priming is not required.
• To administer a dose, the white air pump of the Atzumi device must be squeezed 3 times into 1 nostril to administer the whole dose.
• Inhale while you are squeezing the medicine into your nostril, and release and allow the airpump to expand back to its original shape before squeezing again. Use fast, pulse-like squeezes to deliver the dose.
• The dose may be repeated, if needed, a minimum of 1 hour after the first dose.
• Do not take more than 2 doses in 24 hours.

Atzumi nasal powder is absorbed quickly through your nasal passages and is for use only in the nose.

Your first dose may be given in a medical setting where any serious side effects can be quickly treated.

You should not use dihydroergotamine if you are allergic to it or similar medicines (ergotamine, ergonovine, methylergonovine, and others), or if you have or have ever had:

• heart disease, angina (chest pain), blood circulation problems, coronary artery disease (clogged arteries), or a heart attack or stroke
• uncontrolled high blood pressure
• a serious infection called sepsis
• vascular surgery
• narrowing of blood vessels in the legs, arms, stomach, or kidneys (peripheral vascular disease)
• severe liver or kidney disease.

Some drugs should not be used with dihydroergotamine. Your treatment plan may change if you also use:

• medicines that raise your blood pressure or constrict your blood vessels
• an antibiotic such as troleandomycin, clarithromycin, or erythromycin
• antifungal medicine such as itraconazole or ketoconazole
• antiviral medicines for HIV or hepatitis C.

Before taking, tell your doctor about all your medical conditions, including if you:

• have circulation problems in your arms, hands, legs, or feet
• have chest pain, shortness of breath
• have risk factors for coronary artery disease (high blood pressure, high cholesterol, diabetes, menopause, smoking, family history of coronary artery disease, being overweight, being over 40, and being a man)
• have liver or kidney disease
• are pregnant or planning to become pregnant
• are breastfeeding or planning to breastfeed.

Pregnancy

May cause harm to an unborn baby. There is a risk of preterm labor if women use Atzumi during pregnancy. Atzumi should be avoided during pregnancy. Talk to your healthcare provider right away if you are pregnant or want to become pregnant.

Breastfeeding

Atzumi may reduce breast milk supply and pass into your breast milk, which may be harmful to your baby. Do not breastfeed while using this medicine, and for at least 3 days after your last dose. Talk with your healthcare provider about the best way to feed your baby if you take Atzumi.

The most common side effects of Atzumi are:

• Rhinitis (nasal congestion, runny nose, sneezing, and itching)
• Nausea
• Altered sense of taste
• Irritation and redness where the powder was applied
• Dizziness
• Vomiting
• Sleepiness
• Sore throat
• Diarrhea.

Serious side effects and warnings

Atzumi may cause an allergic reaction. Get emergency medical help if you have signs of an allergic reaction, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Atzumi may cause the following serious side effects:

• A heart attack, restriction of blood flow in the heart, or other cardiac symptoms. In people with risk factors for coronary artery disease, consider administering the first dose of Atzumi under the supervision of a healthcare provider. Seek emergency help if you develop chest pain or pressure, pain spreading to your jaw or shoulder, nausea, or sweating
• Stroke or blood clots/bleeding within the brain. Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have been reported with dihydroergotamine use. Discontinue Atzumi if suspected or seek emergency attention if you develop a severe headache, blurred vision, pounding in your neck or ears, sudden numbness or weakness on one side of the body, chest pain, or problems with vision or speech
• Unexpected narrowing or constriction of the blood vessels (vasopasm). Atzumi may cause vasospasm or an increase in blood pressure. Discontinue if signs or symptoms of vasoconstriction develop, such as pain, numbness, pain or swelling in one leg, skin color changes, or a cold feeling or pale appearance of your fingers or toes
• Abnormal thickening and scarring of tissue (pleural and retroperitoneal fibrosis). This has been reported following prolonged administration of dihydroergotamine products. Seek urgent medical attention if you develop breathing difficulties, cough, or chest pain
• Medication overuse headache. Using medications to treat migraine attacks for 10 or more days per month may lead to more headaches (called medication overuse headache). Record your headache frequency and drug use in a headache diary, and talk to your healthcare provider if your headaches become more frequent
• Serious problems with blood circulation to your legs and feet (peripheral ischemia) after coadministration of CYP3A4 inhibitors. Atzumi can cause peripheral ischemia when you take it with certain medications that strongly inhibit a liver enzyme called CYP3A4, such as macrolide antibiotics and protease inhibitors, which may lead to a stroke and death. Tell your doctor about all your other medicines. Some drugs should not be used with Atzumi nasal powder.

Tell your healthcare provider or seek emergency help if you have:

• bothersome irritation, swelling, or itching in your nose after using Atzumi nasal powder
• sudden or severe stomach pain, weight loss, nausea, vomiting, constipation, bloody diarrhea, fever
• burning sensation in the nose, mouth, throat, and altered sense of taste
• fast or slow heart rate.

Atzumi nasal powder should not be used to treat any headaches that are different from your usual migraine headaches, such as hemiplegic migraines (that make you unable to move on one side of your body) or basilar migraines (a rare form of migraine with aura).

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Onset of migraine: Atzumi 5.2 mg (contents of one device in 1 nostril).

At least 1 hour after the first dose: 5.2 mg (one device) if needed.

Maximum dosage in 24 hours: 10.4 mg (2 devices).

The safety of taking more than 4 doses within 7 days or 12 doses within a 30-day period has not been established.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include slow breathing, blood pressure changes, confusion, hallucinations, agitation, convulsions, coma, nausea, vomiting, stomach pain, and pain, numbness, cold feeling, or pale appearance of your fingers or toes.

Do not use Atzumi within 24 hours before or after using another migraine headache medicine, including:

• another ergot medicine such as ergotamine, dihydroergotamine, ergonovine, methylergonovine; or
• almotriptan, eletriptan, frovatriptan, naratriptan, sumatriptan, or rizatriptan.

Grapefruit may interact with Atzumi and cause side effects. Avoid consuming grapefruit products.

Tell your doctor about all your current medicines. Many drugs can affect dihydroergotamine, especially:

• antibiotics
• heart or blood pressure medication
• HIV or hepatitis medications
• nicotine gum or patches
• an antidepressant
• medicine to treat asthma.

This list is not complete, and many other drugs may affect Atzumi. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Store Atzumi at room temperature in its protective foil pouch until ready to use.

Active ingredient: dihydroergotamine 5.2 mg (equivalent to 6.0 mg dihydroergotamine mesylate)

Inactive ingredients: hypromellose, mannitol, and microcrystalline cellulose.

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. It does not need to be assembled or primed before use.

Available in a carton of 8 nasal devices, each individually packaged in a protective foil pouch.

Atzumi (dihydroergotamine nasal powder) is made by Satsuma Pharmaceuticals, Inc., based in Durham, NC.