Sumavel DosePro (sumatriptan injection) is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and the acute treatment of cluster headache in adults.Limitations of Use:
• Use only if a clear diagnosis of migraine or cluster headache has been established.
• If a patient has no response to the first migraine attack treated with Sumavel DosePro, reconsider the diagnosis of migraine before Sumavel DosePro is administered to treat any subsequent attacks.
• Not indicated for the prevention of migraine attacks.
• For subcutaneous use only.
• Acute treatment of migraine: 4 mg or 6 mg single dose.
• Acute treatment of cluster headache: 6 mg single dose.
• Maximum cumulative dose in a 24-hour period: 12 mg, separate doses by at least 1 hour
• Administer dose only to the abdomen or thigh
There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of Sumavel DosePro. Some of these reactions occurred in patients with no known coronary artery disease (CAD). Sumavel DosePro may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD. Cerebrovascular events, some fatal, have been reported in patients treated with sumatriptan. In a number of cases, it appears possible that the cerebrovascular events were primary, sumatriptan having been administered in the incorrect belief the symptoms experienced were a consequence of migraine when they were not. It is important to advise patients not to administer Sumavel DosePro if a headache being experienced is atypical.
Sumavel DosePro is contraindicated in patients with:
• Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina
• Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
• History of stroke or transient ischemic attack (TIA)
• Hemiplegic or basilar migraine
• Peripheral vascular disease
• Ischemic bowel disease
• Uncontrolled hypertension
• Recent (within 24 hours) use of another 5-HT1 agonist (e.g., another triptan) or of an ergotamine-containing medication
• Current or recent (past 2 weeks) use of monoamine oxidase-A inhibitor
• Known hypersensitivity to sumatriptan
• Myocardial ischemia/infarction and Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors.
• Arrhythmias: Discontinue Sumavel DosePro if occurs.
• Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not associated with myocardial ischemia; evaluate for coronary artery disease in patients at high risk.
• Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue Sumavel DosePro if occurs.
• Gastrointestinal ischemia and infarction events, peripheral vasospastic reactions: Discontinue Sumavel DosePro if occurs.
• Medication overuse headache: Detoxification may be necessary.
• Serotonin syndrome: Discontinue Sumavel DosePro if occurs.
• Seizures: Use with caution in patients with epilepsy or a lowered seizure threshold.
• Increase in blood pressure: Monitor blood pressure.
• Anaphylactic/anaphylactoid reactions: Discontinue Sumavel DosePro if occurs.
In controlled clinical trials with sumatriptan injection, the most common adverse reactions were:
• Injection site reactions
• Warm/hot sensation
• Burning sensation
• Feeling of heaviness
• Pressure sensation
• Feeling of tightness
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.