Sumatriptan

Anaphylactic, anaphylactoid, and hypersensitivity reactions (including angioedema) have been reported; may be life threatening or fatal.

Coronary artery vasospasm, transient ischemia, myocardial infarction, ventricular tachycardia/fibrillation, cardiac arrest, and death have been reported with 5-HT1 agonist administration (some occurring within a few hours of administration). Discontinue sumatriptan if these events occur. Patients who experience sensations of chest pain/pressure/tightness or symptoms suggestive of angina following dosing should be evaluated for coronary artery disease or Prinzmetal angina before receiving additional doses; if dosing is resumed and similar symptoms recur, monitor with ECG.

Cerebral/subarachnoid hemorrhage and stroke (may be fatal) have been reported with 5-HT1 agonist administration. Discontinue sumatriptan if a cerebrovascular event occurs.

May cause CNS depression, such as dizziness, weakness, or drowsiness, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

Significant elevation in blood pressure, including hypertensive crisis, has been reported on rare occasions in patients with and without a history of hypertension. Use is contraindicated in patients with uncontrolled hypertension.

Transient and permanent blindness and significant partial vision loss have been reported (rare) with use of 5-HT1 agonist.

Serotonin syndrome may occur with 5-HT1 agonists, particularly when used concomitantly with other serotonergic drugs; symptoms (eg, diarrhea, hyperreflexia, hyperthermia, incoordination, mental status changes, nausea, tachycardia, vomiting) typically occur minutes to hours after initiation/dose increase of a serotonergic drug. Discontinue use if serotonin syndrome is suspected.

Peripheral vascular ischemia, GI vascular ischemia and infarction, splenic infarction, and Raynaud syndrome have been reported with 5-HT1 agonists. Disease-related concerns:

Perform a cardiovascular evaluation in 5-HT1 agonists-naive patients who have risk factors for CAD (eg, hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, menopause, male >40 years of age) prior to initiation of therapy. Patients with suspected CAD should have cardiovascular evaluation to rule out CAD before considering use; if cardiovascular evaluation is “satisfactory,” first dose should be given in the health care provider's office (consider ECG monitoring). Periodic evaluation of cardiovascular status should be done in these patients during intermittent long-term use.

Use oral formulations of sumatriptan with caution (and with dosage limitations) in patients with mild to moderate hepatic impairment where treatment is necessary and advisable. Presystemic clearance of orally administered sumatriptan is reduced in hepatic impairment, leading to increased plasma concentrations; dosage reduction of the oral product is recommended. Non-oral routes of administration (intranasal, subcutaneous) do not undergo similar hepatic first-pass metabolism and are not expected to result in significantly altered pharmacokinetics in patients with hepatic impairment. Use of the oral, intranasal, Alsuma, Imitrex, and Zembrace injectable is contraindicated in severe hepatic impairment; Sumavel is not recommended in severe hepatic impairment.

Use with caution in patients with history of seizure disorder or in patients with a lowered seizure threshold; seizures have been reported after sumatriptan administration in patients with or without a history of seizures. Concurrent drug therapy issues:

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations:

Use with caution; perform a cardiovascular evaluation prior to initiation of therapy in elderly patients with cardiovascular risk factors (eg, diabetes, hypertension, smoking, obesity, strong family history of coronary artery disease) and periodically during intermittent long-term use. Other warnings/precautions:

Only indicated for the acute treatment of migraine or cluster headache (depending on product); not indicated for migraine or cluster headache prophylaxis, or for the treatment of hemiplegic or basilar migraine. Acute migraine agents (eg, 5-HT1 agonists, opioids, ergotamine, or a combination of the agents) used for 10 or more days per month may lead to worsening of headaches (medication overuse headache); withdrawal treatment may be necessary in the setting of overuse. If a patient does not respond to the first dose, the diagnosis of migraine or cluster headache should be reconsidered; rule out underlying neurologic disease in patients with atypical headache and in patients with no prior history of migraine or cluster headache.