Onzetra Xsail

Onzetra Xsail is a prescription medication used to treat migraine headaches once they have started. Onzetra Xsail belongs to a group of drugs called serotonin receptor agonists or "triptans", which relieve pain by narrowing blood vessels around the brain.

This medication comes as a device that uses your own breath to deliver sumatriptan into your nose and is taken at the first sign of a migraine headache.

Common side effects of Onzetra Xsail are abnormal taste, nasal discomfort, and a stuffy or runny nose. 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.

Onzetra Xsail is a prescription medication used to treat migraine headaches once they have started, with or without aura.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Avanir Pharmaceuticals, Inc.

Serious side effects have been reported with Onzetra Xsail. See the “Onzetra Xsail Precautions” section.

Common side effects of Onzetra Xsail include the following:

• abnormal taste (metallic taste)
• nasal discomfort
• rhinorrhea (runny nose)
• rhinitis (stuffy nose)

This is not a complete list of Onzetra Xsail side effects. Ask your doctor or pharmacist for more information.

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

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

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

Onzetra Xsail and other medicines may affect each other, causing side effects.

Especially tell your healthcare provider if you take:

• Anti-depressant medicines like:
  • selective serotonin reuptake inhibitors (SSRIs) such as escitalopram (Lexapro), sertraline (Zoloft), citalopram (Celexa), vilazodone (Viibryd), paroxetine (Paxil), fluoxetine (Prozac, Sarafem), and fluvoxamine (Luvox)
  • serotonin norepinephrine reuptake inhibitors (SNRIs) such as duloxetine (Cymbalta) and venlafaxine (Effexor)
  • monoamine oxidase inhibitors (MAOIs) such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
• other ergot-containing medications such as dihydroergotamine (D.H.E. 45, MIGRANAL) or methysergide
• other triptans such as sumatriptan (Imitrex, Treximet), eletriptan (Relpax), almotriptan (Axert), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), and zolmitriptan (Zomig)

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.

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

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

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Onzetra Xsail there are no specific foods that you must exclude from your diet when receiving Onzetra Xsail.

Before you use Onzetra Xsail, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Onzetra Xsail or to any of its ingredients
• 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
• become pregnant while taking Onzetra Xsail
• are breastfeeding or plan to breastfeed. Onzetra Xsail passes into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you use Onzetra Xsail.

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

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Onzetra Xsail has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Onzetra Xsail, a choice should be made whether to stop nursing or to stop the use of this medication. The importance of the drug to the mother should be considered.

Administer Onzetra Xsail exactly as prescribed.

Onzetra Xsail comes as a device that uses your own breath to deliver sumatriptan into your nose and is administered after a migraine headache has started.

Take Onzetra Xsail exactly as prescribed. Follow the directions on your prescription label carefully.

The recommended dose of Onzestra Xsail for the treatment of treatment of migraines is 22 mg, administered by use of one nosepiece (11 mg) in each nostril.

The maximum dose in a 24-hour period should not exceed two doses (44 mg) separated by at least 2 hours.

If you have taken more Onzetra Xsail than has been prescribed for you, contact either your doctor, hospital emergency department, or your local Poison Control Center.

• Store at room temperature between 20°C to 25°C (68°F to 77°F)
• Do not store in the refrigerator or freezer.
• Use nosepiece immediately after removing from foil pouch.
• Discard used nosepieces in the trash
• Put the protective cover back on the blue device and store it for your next use
• Cleaning the reusable blue device is not necessary—if you do want to clean the blue device, please use a clean, dry, lint-free cloth to wipe the mouthpiece between uses
• Do not wash the device
• Avoid contact with any liquids
• Keep Onzetra Xsail and all medications out of the reach of children
• Remember to store the blue device and unopened pouches in a clean, cool, and dry place
• Be sure to check the expiration date for each nosepiece at each use