Frequently Asked Questions

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The Device

Why are there 2 separate blue devices?

ONZETRA Xsail comes with 2 reusable blue devices. For your convenience, you can keep one at home and take one with you so you can use ONZETRA Xsail wherever you are. 

Can I replace my device if I lose it?

Your prescription of ONZETRA comes with 2 blue reusable devices. One can be used as a spare if you lose the first device.

Should I be worried if I hear a noise when blowing into my device?

When blowing into the device, you may hear a rattling sound. That’s simply your own breath moving the medication capsule around inside the nosepiece, which is normal.

What does it mean if there is a white residue in the nosepiece after I use it?

A little white residue inside the nosepiece chamber or on the capsule is normal, but if you look closely the medication should be gone. If the capsule appears unused, you can repeat the previous steps with the same nosepiece in the same nostril. Please refer to the complete Instructions for Use found within the full Prescribing Information to ensure proper use.

Should I wash the device?

No, there’s no need to wash the device. Just wipe it with a cloth if necessary. Please refer to the complete Instructions for Use found within the full Prescribing Information to ensure proper use.

How to Use

When should the capsules be pierced?

The capsule should only be pierced when you’re ready to take the medication. Press the white button firmly to pierce the capsule, then release. And remember, this only needs to be done once per nosepiece. Do not hold the white button down while blowing into the device because you will not get any medication. Please refer to the complete Instructions for Use found within the full Prescribing Information to ensure proper use.

How will I know if I am using ONZETRA correctly?

When used correctly, the medication should be gone from the capsule. Check the nosepiece to make sure the medication is not there. A little white residue inside the nosepiece chamber or capsule is normal. Please refer to the complete Instructions for Use found within the full Prescribing Information to ensure proper use.

Examples of capsules used

 

Do I use both nosepieces in 1 nostril?

No, a full dose of ONZETRA is both nosepieces—one in each nostril. Please refer to the complete Instructions for Use found within the full Prescribing Information to ensure proper use.

Are there resources that can teach me how to use ONZETRA?

Yes, we have plenty of resources to learn from. Simply print the Instructions for Use or watch How to use ONZETRA

If I wake up with a migraine, do I need to eat breakfast before I take ONZETRA?

No. You can take ONZETRA on an empty stomach. 

When to Use

When should I use ONZETRA?

A full dose of ONZETRA should be taken when you first start to feel migraine symptoms. Some people who use migraine medicines too often may get worse headaches. Please talk to your doctor if your headaches get worse.

How long will it take to experience relief?

In a clinical study, more than 40% of migraine sufferers experienced pain relief in 30 minutes vs 27% on placebo. At 2 hours, about 70% of migraine sufferers had significant pain relief (68% vs 45% on placebo). ONZETRA may cause serious side effects and should not be used by certain patients, including those with a history of heart problems or who have had a stroke. These are not all the risks of use of ONZETRA.

How often can I take ONZETRA to treat a migraine attack?

If your migraine returns, or you only get some relief from your headache, you can take another full dose of ONZETRA 2 hours after your first full dose. The maximum recommended dose that may be given in 24 hours is two doses of ONZETRA. Do not overuse ONZETRA. If your headaches get worse, talk to your doctor.

How many doses can be taken within a 24-hour period?

The maximum daily dose of ONZETRA should not be more than two full doses (44 mg/4 nosepieces) in a 24-hour period. Do not overuse ONZETRA. If your headaches get worse, talk to your doctor.

If my nose is stuffed up because of a cold or allergies, can I still use ONZETRA?

Yes. As long as the device is used correctly, you can still use ONZETRA when your nose is stuffed up. If you have any questions about using ONZETRA Xsail, please talk to your doctor.

ONZETRA

What kind of medicine is in ONZETRA?

ONZETRA is a sumatriptan nasal powder that’s delivered through a Breath Powered® Xsail device. ONZETRA is not for the prevention of migraine, but is for the acute treatment of migraine.

How does ONZETRA work?

Blowing steadily into the device propels the sumatriptan nasal powder into the back of your nose. The blowing also causes the flap in the back of your throat to close, which may help limit the amount of medicine reaching the stomach or lungs. ONZETRA is designed to deliver medication to the back of your nose. Research suggests that the back of the nose is rich in blood vessels and absorbent tissue, which may help deliver medication into the bloodstream. ONZETRA is for the acute treatment of migraine and not for the prevention of migraine or for other types of headaches, including cluster headaches. Please refer to the complete Instructions for Use found within the full Prescribing Information to ensure proper use.

Is ONZETRA available without a prescription?

ONZETRA is only available with a prescription. Ask your doctor if ONZETRA is right for you.

Should I keep ONZETRA at room temperature?

Yes. Store ONZETRA at room temperature. Keep out of reach of children.

Access and Financial Support

Is ONZETRA covered by insurance?

For information about insurance coverage, please call 1-844-ONZETRA (1-844-669-3872).

We can assist you with reimbursement, including benefit verification and prior authorization, when needed. For those in financial need, we can also help reduce the cost of medication in two ways:

*Benefit cap applies regardless of co-pay amount. Restrictions apply. Those eligible for Medicare, Medicaid, or any other government healthcare program are not eligible for this program.

In addition to calling my doctor, is there more support that I can access?

Yes. ONZETRA Savings & Support is a helpful program that provides support, savings, and information for ONZETRA.

Looking for financial assistance? Have questions about insurance coverage? With ONZETRA Savings & Support, you have access to it all.

Just call 1-844-ONZETRA (1-844-669-3872).

But if you're experiencing any side effects, call your doctor.

Tolerability

What are the side effects?

ONZETRA Xsail may cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop using ONZETRA Xsail and get emergency medical help right away if you have any symptoms of a heart attack like shortness of breath or tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw that is severe or does not go away.

In the clinical studies, sensations typically associated with triptans (ie, chest pressure and tightness) were reported in less than 2% of attacks treated with ONZETRA. None of these events were serious or led people to discontinue ONZETRA. These sensations commonly occur after treatment with triptans and are usually non-cardiac in origin. However, if you have heart problems or a history of heart problems be sure to tell your doctor before using ONZETRA.

The most common side effects reported by people using ONZETRA were a mild metallic taste, nasal discomfort, runny nose, and stuffy nose.

These are not all the possible risks of ONZETRA. Tell your doctor about any side effect that bothers you or does not go away. For additional Important Safety Information about ONZETRA Xsail, please see the full Prescribing Information, including Patient Information and Instructions for Use.

Does ONZETRA have a bad taste?

In clinical trials, only 20% of people experienced an abnormal taste, which the majority felt was mild.

Tap for Safety Information

ONZETRA® Xsail® is a prescription medication approved for the acute treatment of migraine, with or without aura in adults. ONZETRA Xsail is used for people who have been told by a healthcare provider that they have migraine headaches. ONZETRA Xsail is not for the prevention of migraines or for other types of headaches, including cluster headache.

Important Safety Information

What important information should I know about ONZETRA Xsail?
ONZETRA Xsail may cause serious side effects, including:

ONZETRA® Xsail® is a prescription medication approved for the acute treatment of migraine, with or without aura in adults. ONZETRA Xsail is used for people who have been told by a healthcare provider that they have migraine headaches. ONZETRA Xsail is not for the prevention of migraines or for other types of headaches, including cluster headache.

Important Safety Information

What important information should I know about ONZETRA Xsail?

ONZETRA Xsail may cause serious side effects, including:

  • Heart attack and other heart problems, which may lead to death. Stop using ONZETRA Xsail and get emergency medical help right away if you have any symptoms of a heart attack like shortness of breath or tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw that is severe or does not go away
  • Changes in color or sensation in your fingers and toes (Raynaud’s syndrome)
  • Stomach and intestinal problems (gastrointestinal and colonic ischemic events)
  • Problems with blood circulation to your legs and feet (peripheral vascular ischemia)
  • Serious allergic reactions (symptoms include hives; tongue, mouth, lip, or throat swelling; problems breathing)
  • Medication overuse headaches. Some people who use ONZETRA Xsail too many times may have worse headaches. If your headaches get worse your doctor may decide to stop your treatment with ONZETRA Xsail
  • Serotonin syndrome, a rare but serious problem that can happen in people using ONZETRA Xsail, especially if ONZETRA Xsail is used with antidepressant medicines called SSRIs, SNRIs, or TCAs. Call your doctor right away if you have any of the following symptoms of serotonin syndrome: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; trouble walking; or nausea, vomiting, or diarrhea
  • Seizures. Seizures have happened in people taking sumatriptan who have never had seizures before

The most common side effects of ONZETRA Xsail are abnormal taste, discomfort of your nose or throat, runny nose, and stuffy nose. This is not a complete list of side effects. Tell your doctor about any side effect that bothers you or does not go away.

Who should not take ONZETRA Xsail?
Do not take ONZETRA Xsail or stop using ONZETRA Xsail if you:

  • Have heart problems or a history of heart problems
  • Have had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
  • Have uncontrolled high blood pressure
  • Have hemiplegic migraines or basilar migraines. If you are not sure if you have these, ask your doctor
  • Have peripheral vascular disease (narrowing of blood vessels to the legs, arms, stomach, intestines, or kidneys)
  • Have taken other migraine medications in the last 24 hours, including other triptans, ergots, or ergot-type medications. Ask your doctor for a list of these medicines if you are not sure
  • Are taking a medicine called a monoamine oxidase inhibitor (MAOI). MAOIs cannot be taken within 14 days before or after taking ONZETRA Xsail
  • Have severe liver problems
  • Have an allergy to sumatriptan, the medicine in ONZETRA Xsail, or any of the components in ONZETRA Xsail

What should I tell my healthcare provider before taking ONZETRA Xsail?
Before you take ONZETRA Xsail, tell your doctor about all your medical conditions and all the medicines you take, including prescription medicines, especially antidepressants, and all over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while taking ONZETRA Xsail?
ONZETRA Xsail can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 800-FDA-1088.

For additional Important Safety Information about ONZETRA Xsail, please see the full Prescribing Information, including Patient Information and Instructions for Use.