IMPORTANT SAFETY INFORMATION
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
- Uncontrolled hypertension, history of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine
- Peripheral vascular disease
- Ischemic bowel disease
- Recent (i.e., within 24 hours) use of ergotamine-containing medication, ergot derivatives, or another 5-HT1 agonist
- Concurrent or recent (within 2 weeks) use of an 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. 5-HT1 agonists, including Tosymra, may cause coronary artery vasospasm. 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. Cerebrovascular events including cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. Discontinue Tosymra if any of these events occur.
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 consider periodic cardiovascular evaluation in intermittent long-term users of Tosymra. If there is evidence of CAD or coronary artery vasospasm, TOSYMRA is contraindicated. Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with sumatriptan 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 exacerbation of headache (medication overuse headache). Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms may be necessary.
Serotonin syndrome may occur with Tosymra, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors. Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, 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. Discontinue Tosymra if serotonin syndrome is suspected or hypertensive crisis is observed.
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.
Local irritative symptoms were reported in approximately 46% of patients treated with TOSYMRA in an open-label trial that allowed repeated dosing over 6 months. The most common of these were application site reaction (36%), dysgeusia (21%), and throat irritation (5%) with approximately 0.5% of cases reported as severe.
These are not all the side effects associated with Tosymra. Advise the patient to read the FDA-approved patient labeling. Please see Patient Information, Instructions for Use and Full Prescribing Information for Tosymra.
You are encouraged to report negative side effects of prescription drugs. To report SUSPECTED SIDE EFFECTS, call Promius Pharma at 1-888-966-8766 or contact the FDA at 1-800-FDA-1088 (1-800-332-1088) or online at http://www.fda.gov/Safety/MedWatch