Pernix Therapeutics Holdings, Inc. (Pernix) currently holds the rights to all commercialization activities for TREXIMET® in the United States, with Aralez receiving certain royalties. Aralez holds the development and commercialization rights outside the United States, and may seek regulatory approval on the basis of the New Drug Applications (NDA) approved by the FDA for TREXIMET.
TREXIMET® (sumatriptan / naproxen sodium) is approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine attacks, with or without aura, in patients twelve (12) years of age or older.
TREXIMET® is not used to treat other types of headaches such as hemiplegic or basilar migraines. TREXIMET® is not used to prevent or decrease the number of migraine headaches you have. It is not known if TREXIMET® is safe and effective to treat cluster headaches.
Important Safety Information
- TREXIMET® may increase your chance of a heart attack or stroke that can lead to death. Your chance of a heart attack or stroke increases with longer use of NSAID medicines or if you have heart disease or risk factors for heart disease.
- Serious allergic or skin reactions, or stomach and intestine problems such as bleeding and ulcers, can occur without warning and may cause death. Risk of stomach and intestinal problems increases in the elderly.
- Do not take TREXIMET® if you have heart problems, history of heart problems, or have ever had heart bypass surgery; had a stroke, TIAs, or problems with your blood circulation; hemiplegic migraines or basilar migraines; narrowing of blood vessels to your legs and arms, stomach, or kidneys; uncontrolled blood pressure; an allergy to aspirin, NSAIDs, sumatriptan or any of the ingredients in TREXIMET®; taken any medicines in the last 24 hours that are triptans or contain ergotamine; taken an MAOI antidepressant within the last 2 weeks; during third trimester of pregnancy; or liver problems. TREXIMET® should never be used if you have ever had a heart surgery called a coronary artery bypass graft (CABG).
- Before you take TREXIMET®, tell your healthcare provider about all of your medical conditions including if you have risk factors for heart disease like high blood pressure, high cholesterol, diabetes, smoking, obesity, and heart problems or a family history of heart problems or stroke; kidney problems; liver problems; history of epilepsy or seizures; are pregnant, think you might be pregnant, or are trying to become pregnant; are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Serotonin syndrome is a rare but serious problem that can happen in people using TREXIMET®, especially if used with antidepressants called SSRIs or SNRIs.
- The most common side effects of TREXIMET® include: dizziness; feeling weak, drowsy, or tired; pain, discomfort, or stiffness in your neck, throat, jaw, or chest; nausea; tingling or numbness in your fingers or toes; heartburn; dry mouth; feeling hot; heartbeat problems; and muscle tightness.
- For more information, please see the complete Prescribing Information, including BOXED WARNINGS, and the Medication Guide.
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.
This product information is intended only for residents of the United States.