INDICATION
SUMAVEL DosePro is a prescription medicine given with a needle-free delivery system to treat adults who have been diagnosed with acute migraine or cluster headaches.
IMPORTANT SAFETY INFORMATION
• SUMAVEL DosePro is not used to treat other types of headaches or to prevent or lessen the number of migraine or cluster headache attacks you have.
• Do not take SUMAVEL DosePro if you have heart disease or a history of heart disease, narrowing of blood vessels to the legs, arms, stomach or kidney, uncontrolled high blood pressure, migraines that cause temporary paralysis on one side of your body or basilar migraine, had a stroke, transient ischemic attacks or problems with your blood circulation, have taken another triptan or ergotamine medicine in the last 24 hours, or are allergic to sumatriptan.
• Tell your doctor if you have heart disease or a family history of heart disease or stroke, high cholesterol, diabetes, have gone through menopause, are a smoker, have had epilepsy or seizures, or if you are pregnant, nursing, or could become pregnant before taking SUMAVEL DosePro. Especially tell your doctor if you take antidepressant medicines called SSRIs, SNRIs or MAO Inhibitors. A life-threatening problem called serotonin syndrome may occur with SUMAVEL DosePro, especially if used with antidepressants.
• SUMAVEL DosePro can cause serious side effects, including death. Possible side effects include heart attack, fast heartbeat, increase in blood pressure, stroke, changes in mental status such as agitation, hallucinations or coma, tight muscles or trouble walking, changes in color or sensation in fingers or toes, or decreased blood flow to the extremities or intestines.
• Get medical help right away if you have severe tightness, pain, pressure or heaviness in your chest, throat, neck or jaw, shortness of breath or wheezing, sudden or severe stomach pain, hives, swelling of your tongue, mouth or throat, high temperature, trouble seeing, unusual weakness or numbness, nausea, vomiting or diarrhea, or unusual sweating.
• Tell your doctor about all medications you take including prescription and nonprescription medicines, vitamins and herbal supplements.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
