TM Owner Currax Pharmaceuticals
Onzetra Xsail 11mg Nasal Powder
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Indications & Clinical Uses
- Onzetra Xsail is a nasal-powder formulation of sumatriptan, a selective serotonin (5-HT1) receptor agonist ('triptan'), delivered using the breath-powered Xsail device rather than a spray, injection or tablet.
- It is approved for the acute treatment of a migraine attack, with or without aura, in adults; it is not approved to prevent migraine attacks and is not used for cluster headache.
- A full dose is 22 mg, given as two 11 mg nosepieces, one puffed into each nostril; the 11 mg strength on the pack refers to the amount delivered by a single nosepiece.
- Onzetra Xsail is self-administered by the patient at the first sign of a migraine, but should only be used after a healthcare provider has confirmed the diagnosis of migraine and assessed cardiovascular risk, since it is not suitable for everyone.
Side Effects
- The most common side effects are an unusual or unpleasant taste, affecting roughly 1 in 5 users, along with nasal discomfort, a runny nose and nasal irritation, since the powder is delivered directly into the nose.
- Sumatriptan can rarely cause serious heart problems, including heart attack and abnormal heart rhythms, even in people without known heart disease, so chest pain, tightness, pressure or heaviness after a dose needs urgent medical attention.
- There is no boxed warning on the Onzetra Xsail label.
- Seek urgent help for a sudden, severe headache unlike your usual migraine, weakness or numbness on one side of the body, difficulty speaking, or swelling of the face or throat.
- Use Onzetra Xsail only for a confirmed migraine attack, not for other types of headache.
Precautions & Warnings
- Onzetra Xsail must not be used by people with coronary artery disease, a history of heart attack, stroke or transient ischaemic attack, uncontrolled high blood pressure, peripheral vascular disease, ischaemic bowel disease, Wolff-Parkinson-White syndrome, hemiplegic or basilar migraine, or severe liver impairment.
- A cardiovascular check-up is recommended before first use in people with risk factors such as high blood pressure, high cholesterol, diabetes, smoking, obesity, or a family history of heart disease.
- Onzetra Xsail should not be used within 24 hours of another triptan, an ergotamine-type medicine, or another 5-HT1 agonist.
- Its safety in pregnancy has not been established, so discuss migraine treatment options with your healthcare provider if you are pregnant, trying to conceive, or breastfeeding.
Avoid Interactions
- Onzetra Xsail must never be used with, or within 2 weeks of stopping, a monoamine oxidase inhibitor (MAOI), since this can raise sumatriptan levels up to seven-fold and increase toxicity.
- It must not be combined with, or used within 24 hours of, other triptans or ergotamine-type medicines such as dihydroergotamine, because of the added risk of prolonged blood vessel narrowing.
- Combining Onzetra Xsail with SSRIs, SNRIs, tricyclic antidepressants or MAOIs increases the risk of serotonin syndrome - a potentially dangerous combination of confusion, agitation, rapid heart rate, muscle twitching and poor coordination - so tell your healthcare provider about any antidepressant you take.
- Always tell your prescriber and pharmacist about every medicine and supplement you use before starting Onzetra Xsail.
References
Frequently Asked Questions
Onzetra Xsail is a nasal powder form of sumatriptan used to treat a migraine attack, with or without aura, once it has started. It does not prevent migraines and is not approved for cluster headaches or other types of headache.
You puff one 11 mg nosepiece into each nostril using the Xsail device, giving a 22 mg total dose, at the first sign of a migraine. A second dose can be taken later the same day if needed, up to the maximum your doctor sets.
An unusual taste, nasal discomfort and a runny or irritated nose are the most common effects, since the powder is delivered into the nose. Rarely, sumatriptan can cause serious heart problems, so chest pain or pressure after a dose needs urgent attention.
Do not use Onzetra Xsail within 24 hours of another triptan or an ergotamine medicine, or with, or within 2 weeks of, an MAOI. Combining it with SSRIs or SNRIs raises serotonin syndrome risk, so tell your doctor about any antidepressants you take.
People with heart disease, a history of stroke or heart attack, uncontrolled high blood pressure, or hemiplegic or basilar migraine should not use Onzetra Xsail. A heart check-up is recommended first if you have risk factors like high cholesterol, diabetes or smoking.
Onzetra Xsail delivers sumatriptan as a powder into the nose using a breath-powered device, instead of a tablet you swallow or an injection under the skin, which can make it act faster than tablets for some people during a migraine attack.
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