Dihydro­ ergotamine

FDA label

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Renal Contraindicated in severe renal impairment.

Hepatic Contraindicated in severe hepatic impairment.

May repeat once, no sooner than 1 hr after the first dose; max 10.4 mg/24 hr. Safety of more than 4 doses in 7 days or 12 doses in 30 days has not been established.

Instructions

• Nasal administration only.
• Priming is not required.
• Remove the round blue tab from the blue nozzle and insert the nozzle into one nostril.
• Squeeze the white air pump 3 separate times into the SAME nostril while inhaling; let the pump expand back to its original shape between squeezes.
• Use fast, complete, pulse-like squeezes — do not squeeze slowly, partially, or with hesitation.
• Cardiovascular evaluation is recommended before the first dose; for patients with risk factors predictive of coronary artery disease who have a satisfactory evaluation, give the first dose in an equipped healthcare facility.
• Do not use for chronic daily administration and do not exceed the dosing guidelines (fibrotic complications).
• Not indicated for preventive treatment of migraine, or for management of hemiplegic migraine or migraine with brainstem aura.

Contraindications

• Concomitant use of strong CYP3A4 inhibitors (protease inhibitors, macrolides, azole antifungals) — peripheral/cerebral ischemia
• Ischemic heart disease (angina, prior MI, silent ischemia) or coronary artery vasospasm incl. Prinzmetal's variant angina
• Uncontrolled hypertension
• Peripheral arterial disease
• Sepsis
• Following vascular surgery
• Severe hepatic impairment
• Severe renal impairment
• Use of another 5-HT1 agonist or an ergotamine-containing/ergot-type medication within 24 hr
• Concomitant peripheral and central vasoconstrictors — additive or synergistic blood pressure elevation

Cautions

• Myocardial ischemia/infarction and other cardiac events, some fatal (MI, ventricular tachycardia/fibrillation, coronary vasospasm) — cardiovascular evaluation before use; ECG after first dose in patients with risk factors, since ischemia can be silent.
• Cerebrovascular events, some fatal (cerebral and subarachnoid hemorrhage, stroke) — discontinue if a cerebrovascular event is suspected; symptoms may not be migraine.
• Other vasospastic reactions — myocardial, peripheral vascular and colonic ischemia; muscle pain, numbness, coldness, pallor, cyanosis of digits; gangrene or death if circulation is compromised. Discontinue immediately at any sign of vasoconstriction.
• Significant blood pressure elevation, including in patients without a history of hypertension.
• Medication overuse headache with acute migraine drugs used ≥10 days/month — detoxification may be necessary.
• Preterm labor — avoid use during pregnancy.
• Fibrotic complications (pleural and retroperitoneal fibrosis) with prolonged daily use; rare cardiac valvular fibrosis with ergot alkaloids.
• Local nasal irritation in 29% of patients — suspend until resolution if severe with no other attributable cause; monitor for severe recurrent irritation.

Adverse reactions

• Nasal/local irritation — rhinitis 26%; with ATZUMI powder 29% had local irritative symptoms: nasal discomfort 11%, nasal congestion 5%, nasopharyngitis 5%, rhinorrhea 4%, nasal pain 3%, epistaxis 2%
• Nausea 10%, vomiting 4%, diarrhea 2%
• Altered sense of taste 8%
• Application site reactions 6%
• Dizziness 4%, somnolence 3%
• Pharyngitis 3%, cough 3%
• Hot flashes, asthenia, stiffness (≥1%)
• Postmarketing: vasospasm, paresthesia, hypertension, anxiety, dyspnea, flushing, rash, sweating; myocardial infarction and stroke; pleural/retroperitoneal fibrosis with long-term use

Pregnancy Avoid — published data indicate increased risk of preterm delivery; no increased risk of major birth defects or miscarriage in decades of data.

Lactation Do not breastfeed during treatment and for 3 days after the last dose — may reduce milk supply; pump and discard.