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MAXALT is indicated for the acute treatment of migraine attacks with or without aura in adults. MAXALT is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Safety and effectiveness of MAXALT have not been established for cluster headache, which is present in an older, predominantly male population.

Selected Safety Information

MAXALT should not be given to patients with ischemic heart disease (eg, angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal’s variant angina, or other significant underlying cardiovascular disease. Because MAXALT may increase blood pressure, it should not be given to patients with uncontrolled hypertension. MAXALT should not be used within 24 hours of treatment with another 5-HT₁ agonist, or an ergotamine-containing or ergot-type medication like dihydroergotamine or methysergide. MAXALT should not be administered to patients with hemiplegic or basilar migraine. Concurrent administration of MAO inhibitors or use of rizatriptan within 2 weeks of discontinuation of MAO inhibitor therapy is contraindicated. MAXALT is contraindicated in patients who are hypersensitive to rizatriptan or any of its inactive ingredients.

MAXALT should only be used where a clear diagnosis of migraine has been established.

MAXALT can cause coronary vasospasm and should not be given to patients with documented ischemic or vasospastic coronary artery disease (CAD). It is strongly recommended that MAXALT not be given to patients in whom unrecognized CAD is predicted by the presence of risk factors unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of CAD and ischemic myocardial disease or other significant underlying cardiovascular disease. For patients with these risk factors who are determined to have a satisfactory cardiovascular evaluation, see WARNING section of the Prescribing Information.

Serious adverse cardiac events, including acute myocardial infarction, have been reported within a few hours following the administration of rizatriptan. Life-threatening disturbances of cardiac rhythm and death have been reported within a few hours following the administration of other 5-HT₁ agonists. Considering the extent of use of 5-HT₁ agonists in patients with migraine, the incidence of these events is extremely low.

Cases of life-threatening serotonin syndrome have been reported during combined use of selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) and triptans.

The most common adverse events include asthenia/fatigue, somnolence, pain/pressure sensations, and dizziness, and they appear to be dose related. Potentially important adverse events that have occurred in clinical practice and reported through postmarketing surveillance include myocardial ischemia, myocardial infarction, peripheral vascular ischemia, stroke, serotonin syndrome, seizure, dysgeusia, hypersensitivity reaction, anaphylaxis/anaphylactoid reaction, angioedema (eg, facial edema, tongue swelling, pharyngeal edema), wheezing, and toxic epidermal necrolysis.

Before prescribing MAXALT-MLT or MAXALT, please read the Prescribing Information.