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. The dose is a total 22 mg, 11mg 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. 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 11mg 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 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.
The Xsail delivery reusable device is fitted with a disposable nosepiece that is clicked into the nosepiece of the device body. A white button is pressed and released to pierce the capsule inside the nosepiece. It is inserted into the nostril to create a tight seal. While in the nose, the device is rotated so that the mouthpiece can fit into the mouth. The patient blows forcefully through the mouthpiece to deliver the Onnzetra powder into the nasal cavity. Once the medication in the first nosepiece is administered, the nosepiece is removed and discarded. The same process is repeated using a second 11 mg nosepiece in the other nostril.
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.
Onzetra is administered by nasal powder using the Xsail breath-powdered delivery device. The recommended dosage is 22 mg. If the migraine has not resolved within 2 hours after taking Onzetra Xsail, or returns after a limited short-term improvement, a second dose of 22 mg may be administered at least 2 hours after the first dose.
The maximum dosage in a 24-hour period is 44 mg, via 2 doses (4 nosepieces) separated by at least 2 hours. If you have used another sumatriptan product, then you can only use one dose of Onzetra in each 24-hour period. The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established.
Onzetra comes in an 8-dose kit that contains 8 pouches with 2 nosepieces per pouch and 2 breath-powered delivery system bodies. It should be stored at room temperature. Capsules should be used as soon as they are removed from their foil pouch.
For additional details, read the full prescribing information of Onzetra.
- ONZETRA prescribing information available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206099s000lbl.pdf. Accessed 4/27/18.