HeadWise HeadWise: Volume 6, Issue 2 - Page 30

ONZETRA TM Xsail TM provides FAST pain relief

Almost half of migraine sufferers
experienced pain relief in 30 minutes ( 42 % vs 27 %
on placebo ) and 68 % experienced pain relief in 2 hours vs 45 % on placebo .
Breath Powered ® delivery ONZETRA is taken with a small , innovative
device called Xsail . It uses your own breath to
deliver migraine medicine directly to the back of
your nose , an area with the potential for fast absorption
.
Shown in actual size

Important Safety Information

What is ONZETRA TM Xsail TM ( sumatriptan nasal powder ) used for ? 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 .
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 .
30 HeadWise ® | Volume 6 , Issue 2 • 2016
ONZETRA Xsail provides FAST pain relief TM TM Almost half of migraine sufferers experienced pain relief in 30 minutes (42% vs 27% on placebo) and 68% experienced pain relief in 2 hours vs 45% on placebo. Breath Powered ® delivery ONZETRA is taken with a small, innovative device called Xsail. It uses your own breath to deliver migraine medicine directly to the back of your nose, an area with the potential for fast absorption. Shown in actual size Important Safety Information What is ONZETRA TM Xsail TM (sumatriptan nasal powder) used for? 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. 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 fi ngers 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 the H [X[][ۜKY]][ۋ܈XN\X\X][\[\\NYB[\\]\NY]\\XH[[܈]\XKZ][܈X\XB(Z^\\ˈZ^\\]H\[Y[[HZ[[X]\[]H]\YZ^\\YܙBH[[[ۈYHYXوӖUHZ[\HXܛX[\K\Yܝو[\H܈] [BK[YHK\\H\]H\وYHYXˈ[[\܈X][HYHYX]\ž[H܈\]^KXY\H0[YH \YH 8( M