TOSYMRA

Warning

Sumatriptan may cause serious cardiovascular and cerebrovascular events, including myocardial infarction, stroke, and transient ischemic attack.

Contraindications

• Ischemic coronary artery disease
• Wolff-Parkinson-White syndrome
• History of stroke or transient ischemic attack
• Peripheral vascular disease
• Ischemic bowel disease
• Uncontrolled hypertension
• Severe hepatic impairment

Adverse Reactions

• Paresthesia
• Warm/cold sensation
• Chest pain/tightness/pressure
• Vertigo

General Guidance

The maximum daily dose is 200 mg in a 24-hour period. A second dose should only be considered if some response to the first dose was observed, and doses should be separated by at least 2 hours.

Pregnancy

• Sumatriptan should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
• There are no adequate and well-controlled trials in pregnant women

Nursing Mothers

• Sumatriptan is excreted in human milk following subcutaneous administration
• Infant exposure to sumatriptan can be minimized by avoiding breastfeeding for 12 hours after treatment with sumatriptan tablets

Pediatric Use

• Safety and effectiveness in pediatric patients have not been established
• Sumatriptan tablets are not recommended for use in patients younger than 18 years of age

Geriatric Use

• Clinical trials of sumatriptan tablets did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients
• A cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors