Brief Summary of Important Risk Information SAPHRIS®
• Heart problems such as irregular heartbeats, or if you take medicines that can cause irregular heartbeats, because SAPHRIS should be avoided
[SAF-ris] (asenapine) sublingual tablets
This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is SAPHRIS? SAPHRIS is a prescription medicine used for:
• Acute treatment of manic or mixed episodes of bipolar I disorder when used alone in adults or in children (ages 10- 17)
• Acute treatment of manic or mixed episodes of bipolar I disorder when used with a mood stabilizer (lithium or valproate) in adults
• Treatment of schizophrenia in adults
What is the most important information I should know about SAPHRIS? Serious side effects can happen with SAPHRIS, including:
• Increased risk of death in elderly patients with dementia-related psychosis: Medicines like SAPHRIS can increase the risk of death in elderly people who have lost touch with reality due to confusion and memory loss (dementia-related psychosis). SAPHRIS is not approved for treating people with dementia-related psychosis
Who should not take SAPHRIS? People with certain liver problems should not take SAPHRIS. Talk with your healthcare provider before taking SAPHRIS if you have any liver problems. Also, do not take SAPHRIS if you are allergic to asenapine or any of the ingredients in SAPHRIS. Also see “What are the ingredients in SAPHRIS?”
What should I tell my healthcare provider before taking SAPHRIS? Tell your healthcare provider if you have or have had:
• Diabetes or high blood sugar in you or your family. Your healthcare provider should check your blood sugar before you start SAPHRIS and during therapy
• High levels of total cholesterol, triglycerides or LDL-cholesterol or low levels of HDL-cholesterol
• Seizures or conditions that increase your risk for seizures • Low or high blood pressure • Low white blood cell count
STEP 4. Place the whole tablet under tongue and allow it to dissolve completely.
• Pregnancy or plans to become pregnant. It is not known if SAPHRIS will harm your unborn baby
• Any other medical condition
Tell your healthcare provider about all the medicines that you take or recently have taken, including prescription medicines, non-prescription medicines, herbal supplements, and vitamins. SAPHRIS and other medicines may affect each other, causing serious side effects. SAPHRIS may affect the way other medicines work, and other medicines may affect how SAPHRIS works.
How should I take SAPHRIS? Take SAPHRIS exactly as prescribed by your healthcare provider.
IMPORTANT: • For sublingual (under your tongue) use only • Do not remove tablet from the tablet pack until you are ready to take it
• Use dry hands when handling tablet Your SAPHRIS tablets
STEP 1. Firmly press and hold thumb button, then pull out the tablet pack. Do not push tablet through the tablet pack. Do not cut or tear tablet pack.
STEP 2. Peel back the colored tab.
STEP 3. Gently remove the tablet. Do not split, cut, or crush the tablet.
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