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Cautions

Contraindications

• Known or suspected pregnancy and in nursing women.
• Concomitant therapy with peripheral or central vasoconstrictors or potent CYP3A4 inhibitors; recent (i.e., 24 hours) therapy with a 5-HT₁ receptor agonist (e.g., sumatriptan) or an ergot alkaloid (e.g., ergotamine, methysergide). (See Interactions.)
• Known or suspected ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, documented silent ischemia) or coronary artery vasospasm (e.g., Prinzmetal variant angina).
• Known peripheral arterial disease, uncontrolled hypertension, or following vascular surgery.
• Severe hepatic or renal impairment.
• Sepsis.
• Basilar or hemiplegic migraine.
• Known hypersensitivity to ergot alkaloids.

Warnings/Precautions

Warnings

Use only in patients in whom a clear diagnosis of migraine has been established.

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; developmental toxicity observed in animals. Possesses oxytocic properties.

If used during pregnancy, or if pregnancy occurs during therapy, apprise the patient of the potential hazard to the fetus.

Fibrosis

Retroperitoneal and pleuropulmonary fibrosis reported following long-term daily use. Possible fibrotic thickening of cardiac valves with continuous, long-term administration.

Do not administer on a chronic daily basis.

Cardiac Effects

Possible myocardial ischemia and/or infarction, coronary vasospasm, life-threatening cardiac rhythm disturbance, and death. (See Contraindications.)

Use not recommended in patients in whom unrecognized CAD is likely (e.g., postmenopausal women, men >40 years of age, patients with risk factors such as hypertension, hypercholesterolemia, obesity, diabetes mellitus, smoking, or family history of CAD) unless there is satisfactory evidence from a prior cardiovascular evaluation that the patient does not have CAD, ischemic heart disease, or other underlying cardiovascular disease.

Administer initial dose to patients with risk factors for CAD who have completed satisfactory cardiovascular evaluation under medical supervision (e.g., in clinician’s office, possibly followed by ECG) unless patient previously received the drug.

Periodic cardiovascular evaluation recommended in patients with risk factors for CAD if receiving intermittent long-term therapy.

Patients with symptoms suggestive of angina after receiving dihydroergotamine should be evaluated for presence of CAD or predisposition to Prinzmetal variant angina before receiving additional doses.

Cerebrovascular Events

Possible cerebral or subarachnoid hemorrhage, stroke, and other cerebrovascular events, sometimes fatal.

Risk of certain cerebrovascular events (e.g., stroke, hemorrhage, transient ischemic attack) may be increased in patients with migraine.

Other Cardiovascular or Vasospastic Effects

Peripheral vascular ischemia and colonic ischemia reported. Further evaluation recommended if signs or symptoms suggestive of decreased arterial flow (e.g., manifestations of ischemic bowel syndrome or Raynaud’s phenomenon) occur following administration.

Substantial increases in BP reported rarely in patients with or without history of hypertension. (See Contraindications.)

Increases in mean pulmonary artery pressure observed following administration of another 5-HT₁ receptor agonist to patients with suspected CAD who were undergoing cardiac catheterization.

Ergotism

Potential for ergotism, manifested by intense arterial vasoconstriction, producing signs and symptoms of peripheral vascular ischemia; if left untreated, can progress to gangrene. Do not exceed recommended dosages.

If signs and symptoms of impaired circulation occur, immediately discontinue therapy.

Local Effects of Intranasal Administration

Nasal or throat irritation reported frequently following intranasal administration (see Common Adverse Effects under Cautions). Effects of long-term, repeated administration on nasal and respiratory mucosa have not been systematically evaluated to date; however, nasal and throat examinations performed in a limited number of patients revealed no evidence of mucosal injury following repeated administration over periods up to 36 months.

Specific Populations

Pregnancy

Category X. (See Fetal/Neonatal Morbidity and Mortality and also see Contraindications, under Cautions.)

Lactation

Not known whether dihydroergotamine is distributed into milk; however, ergotamine is distributed into milk and may cause vomiting, diarrhea, weak pulse, and unstable BP in nursing infants. Dihydroergotamine is contraindicated in nursing women.

Inhibits prolactin.

Pediatric Use

Safety and efficacy not established in children.

Geriatric Use

Insufficient experience with intranasal dihydroergotamine in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.

Hepatic Impairment

Contraindicated in patients with severe hepatic impairment.

Renal Impairment

Contraindicated in patients with severe renal impairment.

Common Adverse Effects

With parenteral dihydroergotamine, vasospasm, paresthesia, hypertension, dizziness, anxiety, dyspnea, headache, flushing, diarrhea, rash, increased sweating.

With intranasal dihydroergotamine, mild-to-moderate nasal or throat irritation (e.g., congestion, burning sensation, dryness, paresthesia, discharge, epistaxis, pain, soreness), taste disturbances, rhinitis, application site reactions, dizziness, nausea, vomiting.