Sumatriptan - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Myocardial ischemia/infarction and Prinzmetal's angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors.

Arrhythmias: Discontinue sumatriptan injection 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 sumatriptan injection if occurs.

Gastrointestinal ischemic reactions and peripheral vasospastic reactions: Discontinue sumatriptan injection if occurs.

Medication overuse headache: Detoxification may be necessary.

Serotonin syndrome: Discontinue sumatriptan injection if occurs.

Seizures: Use with caution in patients with epilepsy or a lowered seizure threshold.

5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina The use of sumatriptan injection is contraindicated in patients with ischemic or vasospastic CAD.

There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan injection.

Some of these reactions occurred in patients without known CAD.

Sumatriptan injection may cause coronary artery vasospasm (Prinzmetal's angina), even in patients without a history of CAD.

Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving sumatriptan injection.

If there is evidence of CAD or coronary artery vasospasm, sumatriptan injection is contraindicated.

For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of sumatriptan injection in a medically supervised setting and performing an electrocardiogram (ECG) immediately following administration of sumatriptan injection.

For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of sumatriptan injection.

5.2 Arrhythmias Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT 1 agonists.

Discontinue sumatriptan injection if these disturbances occur.

Sumatriptan injection is contraindicated in patients with Wolff-Parkinson-White syndrome or arrhythmias 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 jaw commonly occur after treatment with sumatriptan injection and are usually non-cardiac in origin.

However, perform a cardiac evaluation if these patients are at high cardiac risk.

The use of sumatriptan injection is contraindicated in patients with CAD and those with Prinzmetal's variant angina.

5.4 Cerebrovascular Events Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT 1 agonists, and some have resulted in fatalities.

In a number of cases, it appears possible that the cerebrovascular events were primary, the 5-HT 1 agonist having been administered 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).