INVEGA® (paliperidone) extended-release tablets are indicated for the treatment of schizophrenia in adults and adolescents (12-17 years of age). The efficacy of INVEGA® in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (12-17 years of age), as well as one maintenance trial in adults. INVEGA® (paliperidone) extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressant therapy in adults. The efficacy of INVEGA® in schizoaffective disorder was established in two 6-week trials in adults.
INVEGA® (paliperidone) extended-release tablets are indicated for the treatment of schizophrenia in adults and adolescents (12-17 years of age). The efficacy of INVEGA® in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (12-17 years of age), as well as one maintenance trial in adults.
INVEGA® (paliperidone) extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy in adults. The efficacy of INVEGA® in schizoaffective disorder was established in two 6-week trials in adults.
IMPORTANT SAFETY INFORMATION FOR INVEGA® (paliperidone)
WARNING: Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at
an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10
weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in
the drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated
patients. Over the course of a typical 10-week controlled trial, the rate of death in drugtreated
patients was about 4.5%, compared to a rate of about 2.6% in the placebo group.
Although the causes of death were varied, most of the deaths appeared to be either
cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature.
Observational studies suggest that, similar to atypical antipsychotic drugs, treatment
with conventional antipsychotic drugs may increase mortality. The extent to which the
findings of increased mortality in observational studies may be attributed to the
antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.
INVEGA® is not approved for the treatment of patients with dementia-related psychosis.
Please see full Prescribing Information including Boxed WARNING for INVEGA®.
048983-170303
© Janssen Pharmaceuticals, Inc. 2017. All rights reserved.
Your use of the information on this site is subject to the terms of our Legal Notice. Please see our Privacy Policy.
This site is published by Janssen Pharmaceuticals, Inc., which is solely responsible for its contents. This information is intended for the use of healthcare professionals in the United States only. Janssen Pharmaceuticals, Inc., recognizes that the Internet is a global communications medium; however, laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here may not be appropriate for use outside the United States.
Capitalized product names are trademarks of Janssen Pharmaceuticals, Inc.
Some documents on this site are stored in Adobe PDF format and require the free Adobe® Reader® to view.
This page was last modified on:
EDT