Invega (paliperidone) extended release tablets, an atypical antipsychotic medication, was approved in the U.S. in December 2006.
It is approved for the treatment of schizophrenia in adults and adolescents (12-17 years of age) in the U.S. The efficacy of Invega in schizophrenia was established in three six-week clinical trials in adults and in one six-week trial in adolescents (12-17 years of age), as well as in one maintenance trial in adults.
Invega is the only medication approved to treat schizoaffective disorder in adults. The efficacy of Invega in schizoaffective disorder was established in two six-week trials in adults.
Commonly Observed Adverse Reactions: The most commonly observed adverse reactions in clinical trials occurring at an incidence of greater than or equal to 5% and at least 2 times placebo in the treatment of schizophrenia were:
Adults – extrapyramidal symptoms, tachycardia, and akathisia; Adolescents (12-17 years of age) were: somnolence, akathisia, tremor, dystonia, cogwheel rigidity, anxiety, weight increased and tachycardia.
The most commonly observed adverse reactions in clinical trials occurring at an incidence of greater than or equal to 5% and at least 2 times placebo in the treatment of schizoaffective disorder were: Adults - extrapyramidal symptoms, somnolence, dyspepsia, constipation, weight increased, and nasopharyngitis.
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 drug-treated 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 (e.g., heart failure, sudden death) or infectious (e.g., 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.
Contraindications: Paliperidone is contraindicated in patients with a known hypersensitivity to either paliperidone, risperidone, or to any of the components in the formulation.