Important Safety Information & Indication
ONZETRA Xsail is contraindicated in patients with:
Indication/Limitations of Use
ONZETRA® Xsail® (sumatriptan nasal powder) is indicated for the acute treatment of migraine with or without aura in adults. ONZETRA Xsail should only be used where a clear diagnosis of migraine has been established. ONZETRA Xsail is not indicated for the prevention of migraine attacks or for other types of headaches, including cluster headache.
Important Safety Information
Contraindicated in patients with:
- Ischemic coronary artery disease (CAD) or coronary artery vasospasm, including Prinzmetal’s angina; or Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
- History of stroke, transient ischemic attack (TIA), or hemiplegic or basilar migraine; peripheral vascular disease; ischemic bowel disease; or uncontrolled hypertension
- Recent (i.e., within 24 hours) use of ergotamine-containing or ergot-type medication, or another 5-HT1 agonist; or concurrent or recent (within 2 weeks) use of a MAO-A inhibitor
- Known hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) or severe hepatic impairment
WARNINGS AND PRECAUTIONS
- Myocardial ischemia/infarction, Prinzmetal's angina: These events may occur even in patients without known cardiovascular disease. Perform cardiac evaluation in triptan-naïve patients with multiple risk factors and, if satisfactory, consider administering first dose of ONZETRA Xsail in a medically-supervised setting
- 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-HT1 agonists. Discontinue ONZETRA Xsail if these disturbances occur
- Sensations of chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Commonly occur after treatment with 5-HT1 agonists and are usually non-cardiac in origin. Perform a cardiac evaluation in patients with cardiac risk
- Cerebrovascular Events: Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, exclude other potentially serious neurological conditions
- Other Vasospasm Reactions: 5-HT1 agonists, including ONZETRA Xsail, may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction, splenic infarction, and Raynaud’s syndrome. In patients who experience symptoms or signs suggestive of a vasospastic reaction following the use of any 5-HT1 agonist, rule out a vasospastic reaction before using ONZETRA Xsail
- Medication Overuse Headache: Overuse of acute migraine drugs may lead to exacerbation 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 triptans, including ONZETRA Xsail, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MAOIs). The onset of symptoms usually occurs within minutes to hours of receiving a new or greater dose of a serotonergic medication. Discontinue ONZETRA Xsail if serotonin syndrome is suspected
- Increases in Blood Pressure: Increases in blood pressure have been reported in patients treated with 5-HT1 agonists. Monitor blood pressure in patients treated with ONZETRA Xsail
- Anaphylactic Reactions: Anaphylactic reactions have occurred in patients receiving sumatriptan. Such reactions can be life threatening or fatal. ONZETRA Xsail is contraindicated in patients with a history of hypersensitivity reaction to sumatriptan
- Seizures: Seizures have been reported following administration of sumatriptan, with or without predisposing factors. ONZETRA Xsail should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold
In clinical trials, the most common adverse reactions (≥ 2% and > placebo) were abnormal taste, nasal discomfort, rhinorrhea, and rhinitis.
To report SUSPECTED ADVERSE REACTIONS, contact Avanir Pharmaceuticals at 1-844-ONZETRA (1-844-669-3872) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.