on, ergot-typemedication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1(5-HT1) agonist [see Drug Interactions(7.1, 7.3)].
Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent (within 2weeks) use of an MAO-A inhibitor [see Drug Interactions (7.2) and Clinical Pharmacology(12.3)].
Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) [see Warnings andPrecautions (5.9)].
Severe hepatic impairment [see Clinical Pharmacology (12.3)].
5 WARNINGS AND PRECAUTIONS
5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’sAngina
The use of TOSYMRA is contraindicated in patients with ischemic or vasospastic CAD. Therehave been rare reports of serious cardiac adverse reactions, including acute myocardialinfarction, occurring within a few hours following administration of sumatriptan. Some of thesereactions occurred in patients without known CAD. 5-HT1 agonists, including TOSYMRA,may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a historyof CAD.
Perform a cardiovascular eva luation in triptan-naive patients who have multiple cardiovascularrisk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family historyof CAD) prior to receiving TOSYMRA. If there is evidence of CAD or coronary arteryvasospasm, TOSYMRA is contraindicated. For patients with multiple cardiovascular riskfactors who have a negative cardiovascular eva luation, consider administering the first dose ofTOSYMRA in a medically supervised setting and performing an electrocardiogram (ECG)immediately following administration of TOSYMRA. For such patients, consider periodiccardiovascular eva luation in intermittent long-term users of TOSYMRA.
5.2 Arrhythmias
Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia andventricular fibrillation leading to death, have been reported within a few hours following theadministration of 5-HT1 agonists. Discontinue TOSYMRA if these disturbances occur.
TOSYMRA is contraindicated in patients with Wolff-Parkinson-White syndrome orarrhythmias associated with other cardiac accessory conduction pathway disorders.
5.3 Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure
Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jawcommonly occur after treatment with sumatriptan injection and are usually non-cardiac inorigin. However, perform a cardiac eva luation if these patients are at high cardiac risk. The useof TOSYMRA is contraindicated in patients shown to have CAD and those with Prinzmetal’svariant angina.
5.4 Cerebrovascular Events
Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treatedwith 5-HT1 agonists, and some have resulted in fatalities. In a number of cases, it appearspossible that the cerebrovascular events were primary, the 5-HT1 agonist having beenadministered in the incorrect belief that the symptoms experienced were a consequence of migraine when they were not. Also, patients with migraine may be at increased risk of certain
cerebrovascular events (e.g., stroke, hemorrhage, TIA). Discontinue TOSYMRA if a
cerebrovascular event occurs.
Before treating headaches in patients not previously diagnosed with migraine or in patients whopresent with atypical symptoms, exclude other |
