Onzetra™ (sumatriptan nasal powder)

Onzetra™ (sumatriptan nasal powder) is a serotonin 5-HT1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura, in adults who have a clear migraine diagnosis. It is administered by use of one nosepiece in each nostril.

Onzetra works in as little as 10 minutes and generally within 2 hours. It is intended to reduce acute migraine symptoms. It is only designed to only treat a migraine that has already begun. Onzetra should not to be used as a prophylactic therapy to prevent the onset of migraine or cluster headaches.

Overuse of acute migraine drugs can cause medication overuse headaches. Overuse is considered dosing on more than 10 days per month for 3 months or longer. Symptoms of overuse may need to be treated and detoxification from migraine medications may be required.

What are the ingredients in Onzetra?

The active ingredient in Onzetra is sumatriptan.

How does Onzetra work?

Onzetra is believed to work by binding with 5-HT1B/1D receptors on blood vessels in the brain. It narrows the blood vessels (constriction) around the brain. The effect is to reduce the inflammatory substances in the body that can trigger head pain, nausea, sensitivity to light and sound, and other migraine symptoms.

What are the possible side effects of Onzetra?

Many clinical trials evaluated the safety and efficacy of Onzetra. The most common side effects experienced by those taking Onzetra include:

• Unusual or bad taste in your mouth
• Discomfort, burning, or irritation of the throat or nose
• Runny nose, stuffy nose, and/or post-nasal drip
• Feeling weak, drowsy, or tired
• Pain or tight feeling in the chest, throat, jaw, or neck
• Pressure or heavy feeling in any part of the body
• Numbness or tingling, or feeling hot/cold in the extremities

This is not an exhaustive list of all potential side effects of Onzetra. For more information, consult your doctor or healthcare provider. If you notice any new or worsening side effects when taking Onzetra, contact your doctor or healthcare provider immediately.

Things to note about Onzetra

Onzetra comes in clear capsules for use in a disposable nosepiece. It is intended only for use with the Xsail breath-powered delivery device. Before starting Onzetra talk with your doctor if you:

• Have a history of hypersensitivity to sumatriptan succinate
• Have a history of coronary artery disease (CAD), angina or heart attacks
• Have a history of Wolff-Parkinson-White syndrome or arrhythmias or conduction pathway disorders
• Have a history of stroke or transient ischemic attack (TIA)
• Have a history of hemiplegic or basilar migraine
• Have peripheral vascular disease (circulation in the extremities)
• Have ischemic bowel disease
• Have a history of seizures
• Have a history of uncontrolled hypertension
• Have taken a ergot-containing medication within the 24 hours prior to migraine
• Have taken a MAO-A inhibitor within 2 weeks prior to migraine
• Take anti-depressant medicines including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), or tricyclic antidepressants (TCAs)
• Have severe hepatic (liver) impairment
• Are pregnant or planning to get pregnant, as there is limited information on the use of Onzetra in pregnancy. It should be used only if the potential benefit of Onzetra therapy exceeds risk to the fetus.

Individuals with the above conditions should be monitored closely while taking Onzetra.

If there is no response to the first migraine attack treated with Onzetra Xsail, a physician should reconsider the migraine diagnosis prior to using the medication in any subsequent attacks.

A cardiovascular evaluation should be performed on patients who have never taken a triptan medication but who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) before starting Onzetra. For those with a cardiac history, the first dose of Onzetra should be administered in a medically supervised setting and an electrocardiogram (ECG) should be performed immediately following the dose.

You should begin no medication or supplement without first checking with your health care provider and should let them know of any other prescriptions, OTCs, and herbals you are taking to ensure there are no interactions.

For additional details, read the full prescribing information of Onzetra.