A single spray (0.5 mg) of MIGRANAL Nasal Spray in each nostril
After 15 minutes, a second single spray (0.5 mg) in each nostril, for a total of
4 sprays (2.0 mg)
To get the most out of MIGRANAL Nasal Spray
Do not open vial until ready to use
– Medication may not be fully effective if opened and not used within 8 hours
Allow medication to be absorbed in the nasal mucosal
Do not tilt head or sniff (or inhale through the nose) while spraying. Doing so can make the
medication run down the back of the throat, causing patients to taste the medication, and
making it less likely to work properly
After completing a full dose (4 sprays), carefully dispose of the unused medication, nasal
spray pump, and vial. NEVER reuse the MIGRANAL nasal sprayer
The safety of doses greater than 2.0 mg in a 24-hour period and 4.0 mg in a 7-day period has
not been established
Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with potent CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. 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 these medications is contraindicated.
Migranal Nasal Spray should not be given to patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have clinical symptoms or findings consistent with coronary artery vasospasm, including Prinzmetal's variant angina. Migranal also should not be given to patients with uncontrolled hypertension, patients who have used 5-HT1 agonists, ergotamine-containing or ergot-type medications or methysergide within the last 24 hours, or patients with hemiplegic or basilar migraine. Migranal Nasal Spray is also contraindicated in patients with known peripheral arterial disease, sepsis, following vascular surgery, and severely impaired hepatic or renal function. Migranal Nasal Spray should not be administered to pregnant women or nursing mothers.
Serious cardiac events, including some that have been fatal, have occurred following use of DHE 45 but are extremely rare. During clinical studies and the foreign postmarketing experience with Migranal Nasal Spray, there have been no fatalities due to cardiac events.
The most commonly reported adverse events in clinical trials for Migranal Nasal Spray were rhinitis, altered sense of taste, application site reactions, dizziness, nausea and vomiting. Adverse events associated with discontinuation were rhinitis, dizziness, facial edema, cold sweats, accidental trauma, depression, elective surgery, somnolence, allergy, vomiting, hypotension, and paresthesia.
