TOSYMRA™ is contraindicated in patients with:
- Ischemic Coronary Artery Disease (CAD) 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 or history of hemiplegic or basilar migraine
- Peripheral vascular disease
- Ischemic bowel disease
- Uncontrolled hypertension
- Recent (i.e., within 24 hours) use of ergotamine-containing medication, ergot-type medication, or another 5-HT1 agonist
- Concurrent or recent (within 2 weeks) use of a monoamine oxidase (MAO)-A inhibitor
- Known hypersensitivity to sumatriptan (angioedema and anaphylaxis seen)
- Severe hepatic impairment
There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan. Some of these reactions occurred in patients without known CAD. TOSYMRA, like other 5-HT1 agonists, may cause coronary artery vasospasm. Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors prior to receiving TOSYMRA. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of TOSYMRA in a medically supervised setting and performing an ECG immediately following administration. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of TOSYMRA.
Life-threatening disturbances of cardiac rhythm, leading to death in some cases, have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue TOSYMRA if any of these cardiovascular disturbances occur.
Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. Discontinue TOSYMRA if these occur.
Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with sumatriptan injection and are usually non-cardiac in origin.
TOSYMRA may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction, splenic infarction, and Raynaud’s syndrome.
Overuse of acute migraine drugs may lead to medication overuse headache. Detoxification of patients and treatment of withdrawal symptoms may be necessary.
Serotonin syndrome may occur with TOSYMRA, particularly during co-administration with selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, tricyclic antidepressants, and MAO inhibitors. Discontinue TOSYMRA if serotonin syndrome is suspected.
Significant elevation in blood pressure, including hypertensive crisis, has been reported on rare occasions in patients treated with 5-HT1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with TOSYMRA.
Seizures have been reported following administration of sumatriptan. Some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures. TOSYMRA should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.
Most common adverse reactions (≥5% and > placebo) with sumatriptan injection were tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness.
This safety information is not comprehensive. Please refer to the TOSYMRA full Prescribing Information, Patient Information, and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.
You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.