Onzetra Xsail (Page 5 of 6)


16.1 How Supplied

ONZETRA Xsail is supplied as a disposable nosepiece containing a capsule and a reusable breath-powered delivery device body. Each capsule contains 11 mg sumatriptan base (equivalent to 15.4 mg of sumatriptan succinate nasal powder) in a clear, hypromellose capsule with 825 printed on one side.

ONZETRA Xsail is available in kits containing 8 doses.

The following table provides a description of the packaging configurations:

Description Contents NDC Code
8 Dose Kit 8 pouches containing 2 nosepieces (22 mg sumatriptan) per pouch. Each nosepiece contains 11 mg sumatriptan2 breath-powered delivery system bodies 42847-311-08

16.2 Storage and Handling

Store at room temperature between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Do not store in the refrigerator or freezer. Use nosepiece immediately after removing from foil pouch.


Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Only patients who are able to understand and follow the instructions should use ONZETRA Xsail.

Instructions on the proper use of ONZETRA Xsail from a physician or healthcare professional prior to administration for the first time may be helpful. For support, healthcare professionals and patients can call 1-800-793-2145 or see www.ONZETRA.com.

Risk of Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events

Inform patients that triptan medications, including ONZETRA Xsail, may cause serious cardiovascular side effects such as myocardial infarction or stroke, which may result in hospitalization and even death. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, irregular heartbeat, significant rise in blood pressure, weakness, and slurring of speech and should ask for medical advice if any indicative signs or symptoms are observed. Apprise patients of the importance of this follow-up [see Warnings and Precautions (5.1, 5.2, 5.3, 5.4, and 5.5)].

Hypersensitivity Reactions

Inform patients that anaphylactic reactions have occurred in patients receiving sumatriptan. Such reactions can be life-threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens [see Warnings and Precautions (5.9)].

Concomitant Use with Other Triptans and Ergot Medications

Inform patients that use of ONZETRA Xsail within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated [see Contraindications (4) and Drug Interactions (7.1, 7.3)].

Serotonin Syndrome

Caution patients about the risk of serotonin syndrome with the use of ONZETRA Xsail or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7) and Drug Interactions (7.4)].

Medication Overuse Headache

Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions (5.6)].


Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant [see Use in Specific Populations (8.1)].

Nursing Mothers

Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.2)].

Ability To Perform Complex Tasks

Treatment with sumatriptan may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks during migraine attacks and after administration of ONZETRA Xsail.

Local Irritation

Inform patients that they may experience local irritation of their nose and throat. The symptoms will generally resolve in less than 2 hours.

How to Use ONZETRA Xsail with the breath powered device

Provide patients with instructions on the proper use of ONZETRA Xsail with the breath powered device.

Advise patients that use of the breath powered device is for ONZETRA Xsail only. No other product or substance is approved for use in the breath powered device.

Advise patients to remove a disposable nosepiece from the foil pouch, remove the clear device cap from the reusable device, and click the nosepiece into the device body.

Advise the patient to fully press and release the white piercing button on the device body to pierce the capsule inside the nosepiece. Instruct the patient to press the white piercing button only once.

Advise the patient to insert the nosepiece into the nostril so that it makes a tight seal. The device is then rotated and the mouthpiece inserted between the lips.

Instruct the patient to blow forcefully through the mouthpiece to deliver the sumatriptan powder into the nasal cavity. Vibration (e.g., a rattling noise) may occur, and indicates that the patient is blowing forcefully, as directed.

Advise the patient to remove and discard the nosepiece in the trash once the medication has been administered.

Instruct the patient to follow the same process using a second nosepiece in the other nostril to administer the remainder of the total recommended dose.

ONZETRA and Xsail are registered trademarks of Currax™ Pharmaceuticals LLC in the United States and other countries

Distributed by:
Currax™ Pharmaceuticals LLC
Morristown, NJ 07960

©2019 Currax™ Pharmaceuticals LLC All rights reserved

Patient Information
ONZETRA® (On ze’ trah) Xsail® (Eks’-seil) (sumatriptan nasal powder) 11 mg

Read this Patient Information before you start using ONZETRA Xsail and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is the most important information I should know about ONZETRA Xsail?

ONZETRA Xsail can cause serious side effects, including:

Heart attack and other heart problems. Heart problems may lead to death.

Stop taking ONZETRA Xsail and get emergency medical help right away if you have any of the following symptoms of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

ONZETRA Xsail is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:

  • have high blood pressure
  • have high cholesterol levels
  • smoke
  • are overweight
  • have diabetes
  • have a family history of heart disease

What is ONZETRA Xsail?

ONZETRA Xsail is a prescription medicine used to treat acute migraine headaches with or without aura in adults.

ONZETRA Xsail is not used to treat other types of headaches such as hemiplegic migraines (that make you unable to move on one side of your body) or basilar migraines (rare form of migraine with aura).

ONZETRA Xsail is not used to prevent or decrease the number of migraine headaches you have.

It is not known if ONZETRA Xsail is safe and effective to treat cluster headaches.

It is not known if ONZETRA Xsail is safe and effective in children under 18 years of age.

Who should not use ONZETRA Xsail?

Do not use ONZETRA Xsail if you have:

  • an allergy to sumatriptan
  • heart problems or history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • severe liver problems
  • hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider.
  • had a stroke, transient ischemic attacks (TIAs) or problems with your blood circulation
  • taken any of the following medicines in the last 24 hours:
    • almotriptan (AXERT®)
    • eletriptan (RELPAX®)
    • frovatriptan (FROVA®)
    • naratriptan (AMERGE®)
    • rizatriptan (MAXALT® , MAXALT-MLT®)
    • zolmitriptan (ZOMIG® , ZOMIG-ZMT® , ZOMIG® NASAL SPRAY)
    • sumatriptan and naproxen (TREXIMET®)
    • sumatriptan (SUMAVEL® DOSE PRO® INJECTION)
    • sumatriptan (ALSUMA®)
    • sumatriptan (ZECUITY® TRANSDERMAL PATCH)
    • ergotamines (CAFERGOT® , ERGOMAR® , MIGERGOT®)
    • dihydroergotamine (D.H.E. 45® , MIGRANAL®)Ask your healthcare provider if you are not sure if your medicine is listed above.

What should I tell my healthcare provider before taking ONZETRA Xsail?

Before you use ONZETRA Xsail, tell your healthcare provider about all of your medical conditions, including if you:

  • have high blood pressure
  • have high cholesterol
  • have diabetes
  • smoke
  • are overweight
  • have heart problems or a family history of heart problems or stroke
  • have kidney problems
  • have liver problems
  • have had epilepsy or seizures
  • are not using effective birth control
  • are pregnant or plan to become pregnant. It is not known if ONZETRA Xsail can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. ONZETRA Xsail passes into your breast milk. It is not known if this can harm your baby. Talk with your healthcare provider about the best way to feed your baby if you use ONZETRA Xsail.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.

ONZETRA Xsail and certain other medicines can affect each other, causing serious side effects.

Especially tell your healthcare provider if you take anti-depressant medicines called:

  • selective serotonin reuptake inhibitors (SSRIs)
  • serotonin norepinephrine reuptake inhibitors (SNRIs)
  • tricyclic antidepressants (TCAs)
  • monoamine oxidase inhibitors (MAOIs)

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I use ONZETRA Xsail?

Before using ONZETRA Xsail, read the Patient Instructions for Use.

  • Certain people should use their first dose of ONZETRA Xsail in their healthcare provider’s office or in another medical setting. Ask your healthcare provider if you should use your first dose in a medical setting.
  • Use ONZETRA Xsail exactly as your healthcare provider tells you to use it.
  • Use a full dose (2 nosepieces) to treat your headache.
  • If you do not get any relief after your first full dose, do not use a second dose without first talking with your healthcare provider.
  • If your headache comes back after the first full dose or you only get some relief from your headache, you can use a second full dose 2 hours after the first full dose.
  • Do not take more than a total of 44 mg (two full doses) of ONZETRA Xsail in a 24-hour period.
  • It is not known how using ONZETRA Xsail for a long time affects the nose and throat.
  • If you use too much ONZETRA Xsail, call your healthcare provider or go to the nearest hospital emergency room right away.
  • You should write down when you have headaches and when you take ONZETRA Xsail so you can talk with your healthcare provider about how ONZETRA Xsail is working for you.

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.

What are the possible side effects of ONZETRA Xsail?

ONZETRA Xsail may cause serious side effects. See “What is the most important information I should know about ONZETRA Xsail?

These serious side effects include:

  • changes in color or sensation in your fingers and toes (Raynaud’s syndrome)
  • stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include:
    • sudden or severe stomach pain
    • stomach pain after meals
    • weight loss
    • nausea or vomiting
    • constipation or diarrhea
    • bloody diarrhea
    • fever
  • problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:
    • cramping and pain in your legs or hips
    • feeling of heaviness or tightness in your leg muscles
    • burning or aching pain in your feet or toes while resting
    • numbness, tingling or weakness in your legs
    • cold feeling or color changes in 1 or both legs or feet
  • hives (itchy bumps); swelling of your tongue, mouth or throat
  • medication overuse headaches. Some people who use too much sumatriptan may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with ONZETRA Xsail.
  • serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using ONZETRA Xsail, especially if ONZETRA Xsail is used with anti-depressant medications called SSRIs or SNRIs. Call your healthcare provider 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
  • seizures. Seizures have happened in people taking sumatriptan who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take ONZETRA Xsail.

The most common side effects of ONZETRA Xsail include:

  • unusual or bad taste in your mouth
  • discomfort of your throat or nose
  • runny nose, stuffy nose, and/or postnasal drip

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of ONZETRA Xsail. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ONZETRA Xsail?

  • Store at room temperature, between 68°F to 77°F (20°C to 25°C).
  • Do not store in the refrigerator or freezer.

Keep ONZETRA Xsail and all medicines out of the reach of children.

General information about the safe and effective use of ONZETRA Xsail.

  • ONZETRA Xsail is to be used only with the Xsail breath-powered device.
  • Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets.
  • Do not use ONZETRA Xsail for a condition for which it was not prescribed.
  • Do not give ONZETRA Xsail to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about ONZETRA Xsail. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ONZETRA Xsail that is written for healthcare professionals.

For more information, go to www.ONZETRA.com or call 1-800-793-2145.

What are the ingredients in ONZETRA Xsail?

  • Active ingredient: sumatriptan succinate
  • Inactive ingredient: hypromellose (capsule)

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 12/2019

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