ONZETRA XSAIL Rx
Generic Name and Formulations:
Sumatriptan 11mg; per cap; nasal pwd for inh.
Indications for ONZETRA XSAIL:
Acute treatment of migraine with or without aura.
Limitations Of use:
Confirm diagnosis; reconsider if no response after treatment. Not established for treatment of cluster headache.
Administer using the Xsail breath-powered delivery device. Use 1 nosepiece (11mg) in each nostril. ≥18yrs: 22mg (2 nosepieces). Reevaluate if no response or returns after transient improvement. May repeat once after ≥2hrs; max 44mg (4 nosepieces)/day or one dose of Onzetra Xsail and one dose of another sumatriptan product separated by ≥2hrs. The safety of treating an average of more than 4 headaches in a 30-day period has not been established.
<18yrs: not established.
Ischemic coronary artery disease (CAD) (eg, angina, history of MI, silent ischemia). 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 TIA. History of hemiplegic or basilar migraine. Peripheral vascular disease. Ischemic bowel disease. Uncontrolled hypertension. Within 24hrs of ergot-type drugs (eg, methysergide, dihydroergotamine) or other 5-HT1 agonists. During or within 2 weeks of an MAO-A inhibitor. Severe hepatic impairment.
Avoid excessive use. Exclude underlying neurologic or cardiovascular disease, supervise 1st dose, and consider monitoring ECG in patients with multiple risk factors (eg, increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD). Monitor BP, cardiovascular function in long-term intermittent use. Discontinue if serious arrhythmias or cerebrovascular events occur or if serotonin syndrome is suspected. Peripheral or GI vascular ischemia and infarction following other 5-HT1 agonists. History, or risk of seizures. Elderly. Pregnancy (Cat.C). Nursing mothers (avoid nursing for 12 hours after treatment).
Selective 5-HT1B/1D receptor agonist.
Ergotamines, other 5-HT1 agonists, MAO-A inhibitors: see Contraindications. Increased risk of serotonin syndrome with SSRIs, SNRIs, tricyclics, or MAO inhibitors.
Abnormal taste, nasal discomfort, rhinorrhea, rhinitis; chest, throat, neck and/or jaw pain/tightness/pressure, medication overuse headache; rare: serious cardiac and cerebrovascular events (including fatalities), vision loss, hypertensive crisis, hypersensitivity reactions.
Kit—1 (8 pouches each containing 2 nosepieces) + (2 breath-powered delivery system)