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:

What 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.