AXERT® is a 5HT1B/1D receptor agonist (triptan) indicated for:

• Acute treatment of migraine attacks in adults with a history of migraine with or without aura (1.1)
• Acute treatment of migraine headache pain in adolescents age 12 to 17 years with a history of migraine with or without aura, and who have migraine attacks usually lasting 4 hours or more (1.1)

Important limitations:

• Use only after a clear diagnosis of migraine has been established (1.2)
• In adolescents age 12 to 17 years, efficacy of AXERT® on migraine-associated symptoms was not established (1.2)
• Not intended for the prophylactic therapy of migraine (1.2)
• Not indicated for the treatment of cluster headache (1.2)

• Adults and adolescents age 12 to 17 years: 6.25 mg or 12.5 mg single dose; may repeat after 2 hours if headache returns; benefit of second dose in patients who have failed to respond to first dose has not been established; maximum daily dose 25 mg (2.1)
• Patients with hepatic or severe renal impairment: 6.25 mg starting dose; maximum daily dose 12.5 mg (2.2, 2.3)

Tablets: 6.25 mg and 12.5 mg (3)
CONTRAINDICATIONS

• Ischemic heart disease, coronary artery vasospasm, or other significant underlying cardiovascular disease (4.1)
• Cerebrovascular syndromes (e.g., history of stroke or TIA) (4.2)
• Peripheral vascular disease (including ischemic bowel disease) (4.3)
• Uncontrolled hypertension (4.4)
• Do not use AXERT® within 24 hours of an ergotamine-containing, or ergot-type medication, or of another 5-HT1 agonist, e.g., another triptan (4.5, 4.6)
• Hemiplegic or basilar migraine (4.7)
• Known hypersensitivity to AXERT® (4.8)

• Serious adverse cardiac events, including acute myocardial infarction and life-threatening disturbances of cardiac rhythm (5.1)
• It is strongly recommended that AXERT® not be given to patients in whom unrecognized coronary artery disease (CAD) is predicted by the presence of risk factors. In very rare cases, serious cardiovascular events have been reported in association with AXERT® use in the absence of known cardiovascular disease. If AXERT® is considered, patients should first have a cardiovascular eva luation. If the eva luation is satisfactory, first dose should take place in a physician's office setting (5.1)
• Sensations of pain, tightness, pressure, and heaviness in the chest, throat, neck, and jaw: generally not associated with myocardial ischemia, but patients with signs or symptoms suggestive of angina should be eva luated for the presence of CAD (5.2)
• Cerebrovascular events, some fatal (5.3)
• Gastrointestinal ischemic events and peripheral vasospastic reactions (e.g., Raynaud's syndrome) (5.4)
• Potentially life-threatening serotonin syndrome, particularly in combination with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). Monitor patients for neurologic changes and gastrointestinal symptoms if concomitant treatment is clinically warranted (5.5, 7.3)
• Medication overuse headache: Detoxification may be necessary (5.6)
• Increase in blood pressure, very rarely associated with significant clinical events (4.4, 5.7)
• Use with caution in patients with a known hypersensitivity to sulfonamides (5.8)

• Do not use AXERT® and ergotamine-containing or ergot-type medications within 24 hours of each other (4.5, 7.1)
• Do not use AXERT® and other 5-HT1 agonists (e.g., triptans) within 24 hours of each other (4.6, 7.2)
• SSRI or SNRI: life-threatening serotonin syndrome reported during combined use with triptans (5.5, 7.3)
• Ketoconazole: use single dose of AXERT® 6.25 mg; maximum AXERT® daily dose 12.5 mg (7.4)

• Pregnancy: based on animal data, may cause fetal harm (8.1)
• Nursing mothers: use AXERT® with caution (8.3)
• Pediatric use: AXERT® has not been studied in children under 12 years (8.4)
• Geriatric use: insufficient safety and efficacy data; use with caution, usually starting with the 6.25 mg dose (8.5)
• Hepatic impairment: use single 6.25 mg tablet as a starting dose; maximum daily dose 12.5 mg (2.2, 8.6)
• Severe renal impairment: use single 6.25 mg tablet as a starting dose; maximum daily dose 12.5 mg (2.3, 8.7)