IMPORTANT SAFETY INFORMATION

AXERT® tablets are indicated for the acute treatment of migraine with or without aura in adults. AXERT® tablets are indicated for the acute treatment of migraine headache pain in adolescents age 12 to 17 years with a history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated). In adolescents age 12-17 years, efficacy of AXERT® on migraine associated symptoms (nausea, photophobia and phonophobia) was not established.

AXERT® is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Safety and effectiveness of AXERT® have not been established for cluster headache which is present in an older, predominantly male population.

IMPORTANT SAFETY INFORMATION
AXERT® tablets should be used only when a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with AXERT®, the diagnosis of migraine should be reconsidered before AXERT® is administered to treat any subsequent attacks. AXERT®, like other triptans, has been associated with coronary vasospasm and therefore should not be given to patients with ischemic heart disease 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. AXERT®, like other triptans in this class, should not be given to patients in whom unrecognized coronary artery disease (CAD) is predicted by risk factors (family history, high cholesterol, high blood pressure, diabetes, or obesity). Do not use AXERT® in patients with cerebrovascular syndromes including (but not limited to) stroke of any type as well as transient ischemic attacks. Certain cerebrovascular events and serious cardiac events have been reported in patients treated with triptans, and some events have resulted in fatalities. Do not use AXERT® in patients with peripheral vascular disease including (but not limited to) ischemic bowel disease. Because AXERT® may increase blood pressure, it should not be given to patients with uncontrolled hypertension.

In very rare cases, serious cardiovascular events have been reported in association with AXERT® use in the absence of known cardiovascular disease. If treatment is considered, patients should first have a cardiovascular evaluation and the first dose should take place in a physician's office setting. Sensations of pain, tightness, pressure and heaviness in the chest, throat, neck, and jaw have been reported with AXERT® and other triptans. This is generally not associated with myocardial ischemia, but patients with signs or symptoms suggestive of angina should be evaluated for the presence of CAD. Patients who experience symptoms or signs suggestive of decreased arterial flow following the use of any triptan, such as ischemic bowel syndrome or Raynaud's syndrome, are candidates for further evaluation.

The development of a potentially life-threatening serotonin syndrome may occur with triptans, including AXERT® treatment, particularly when combined with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). If combined treatment with AXERT® and an antidepressant is clinically warranted, patients should be closely observed for signs and symptoms of the serotonin syndrome such as mental status changes, hyperthermia, diaphoresis, labile blood pressure, tachycardia, hyperreflexia, incoordination and/or gastrointestinal symptoms, especially during treatment initiation and dosage escalation. Patients with the serotonin syndrome require immediate medical attention.

Do not use AXERT® within 24 hours of ergotamine-containing or ergot-type medications, or another 5-HT1 agonist (e.g. triptan). Patients taking ketoconazole need a lower dose of AXERT®. Do not use if known hypersensitivity exists to AXERT®. Use with caution in patients with known hypersensitivity to sulfonamides.

The most common side effects in adults are nausea, somnolence, paresthesia, headache and dry mouth.

The most common side effects in adolescents are dizziness, somnolence, headache, paresthesia, nausea and vomiting.

For more detailed information, please see full Prescribing Information.