WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warnings. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. SAPHRIS is not approved for the treatment of patients with dementia-related psychosis. Saphris (asenapine) may interact with certain medications. Be sure to tell your doctor about any medications you take, including prescription, over-the-counter, vitamins, and herbal supplements. Saphris (asenapine) may not be right for everyone. Tell your doctor if you: Have dementia-related psychosis as your risk of cerebrovascular events such as stroke or heart disease is increased with the use of Saphris., Have diabetes or dyslipidemia. You should monitor for changes in blood sugar levels and weight while taking Saphris., Experience fever, rigid muscles, confusion, rapid heart rate, or sweating while taking Saphris as these could be signs of neuroleptic malignant syndrome (NMS). If NMS is suspected, stop taking Saphris immediately and seek medical care right away., Experience tardive dyskinesia, or uncontrollable movements of the face, neck, or tongue, Saphris may be stopped if clinically appropriate., Have blood pressure problems. You should monitor your heart rate and blood pressure while taking Saphris as it can cause a sudden drop in blood pressure when you stand up from lying down or sitting., Have a low white blood cell count (WBC) or have had leukopenia or neutropenia. If your WBC count declines significantly without any other cause, your doctor may discontinue Saphris., Have risk factors for QT prolongation.Do not take Saphris with drugs that may also increase the QT interval., Have a history of seizures or if you have a condition(s) that increases your risk for seizures., Have problems sleeping. Saphris may cause sleepiness or drowsiness. Use caution when driving or operating machinery., Are pregnant or plan to become pregnant. Taking Saphris while pregnant may increase the risk of extrapyramidal symptoms and/or symptoms of withdrawal in neonates. Women should be advised of the possible risk to the fetus. Please note that there is a pregnancy exposure registry. This registry monitors the health of mom and baby while taking Saphris during pregnancy., Are breastfeeding or plan to start breastfeeding. The effects of Saphris (asenapine) while breastfeeding are unknown. Benefits versus risks must be considered.
