Talking to Your Doctor About MIGRANAL

If you’re like most migraine sufferers, you may be unsatisfied with your current migraine treatment. It’s important for you to know that there are other options to treat your migraine pain. Here’s a way to make sure you’re getting the best results from your current prescription: complete this questionnaire, print it out, and take it to your next doctor’s visit to help initiate a discussion.

  YES NO
1. Have you been diagnosed as suffering from migraines?
If so, continue. If not, go to Talking to Your Doctor About Migraines.
2. Are you satisfied with your current migraine treatment?
3. Does your current migraine treatment provide relief every time you use it?
4. Do you find it difficult to take your current migraine treatment as prescribed? (i.e. At the first sign of a migraine attack?)
5. Are you afraid of wasting your medication by using it at the wrong time?
6. Do you get new migraine attacks within 24 hours of treating old ones?
   

 

IMPORTANT SAFETY INFORMATION:

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.

Please see accompanying complete prescribing information including BOXED warning.