WARNING:INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. INVEGA® is not approved for use in patients with dementia-related psychosis. Before you begin treatment with Invega ER, talk to your doctor about:, All the medications you take, including any prescription and over-the-counter medications, vitamins, and herbal supplements, Any allergies you have, Your medical history and current health problems, Your pregnancy status or breastfeeding status, Elderly patients with psychoses associated with dementia are at an increased risk of stroke, heart attack, or other life-threatening cerebrovascular events with the treatment of Invega ER., Neuroleptic malignant syndrome can occur with the use of Invega ER. Seek emergency care right away if you develop overactive reflexes, stiff muscles, delirium, irregular pulse or blood pressure, rapid heart rate, sweating, and heart arrhythmias., Invega ER can cause QT prolongation in patients who take other QT-prolonging medications or in patients who have risk factors for QT prolongation. Talk to your doctor about your risks., Invega ER can cause involuntary movements that may not be reversible., Invega ER can cause high blood sugar levels, abnormal lipid levels, and weight gain., Invega ER can increase prolactin levels., Treatment with Invega ER can increase the risk of gastrointestinal obstruction. Patients with pre-existing conditions that cause gastrointestinal narrowing should avoid taking Invega ER., Low blood pressure upon standing and fainting can occur during treatment with Invega ER., Because Invega ER can cause low blood pressure, the risk of falls is increased, especially in elderly patients., Invega ER can lower the counts of some types of white blood cells, including leukocytes, neutrophils, and granulocytes., Invega ER can cause drowsiness, sedation, and dizziness; therefore, you should not drive or operate machinery until you know how Invega ER affects you., Invega ER can cause seizures and should be used with caution if you have a history of seizure or other conditions that can cause seizures., Invega ER can cause difficulty swallowing or aspiration, which can lead to aspiration pneumonia that can be fatal., Invega ER can cause an erection that lasts for a long time., Invega ER can affect the body's ability to decrease core body temperature. All the medications you take, including any prescription and over-the-counter medications, vitamins, and herbal supplements, Any allergies you have, Your medical history and current health problems, Your pregnancy status or breastfeeding status