Migranal works on many receptors in both the central and peripheral
parts of your brain. Although the clinical significance of this activity is
unknown, this may enable you to experience proven relief at any time
during your attack.
Although treating a migraine attack early is always recommended, any time
may be the right time to treat with MIGRANAL. You can take MIGRANAL at
the start of an attack or in the middle of it – even if you wake up with a
full-blown migraine – and still anticipate relief.
Clinical studies show that approximately 30% to 61% of patients with
moderate to severe migraine find relief with Migranal at 2 hours and 47%
to 70% of patients find relief at 4 hours. The most commonly reported
adverse events in clinical trials reported by at least 5% of the treated
population were rhinitis, altered sense of taste, nausea and application
site reaction.
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.
