INVEGA® is an atypical antipsychotic agent indicated for the 

• acute and maintenance treatment of schizophrenia 
• acute treatment of schizoaffective disorder as monotherapy 
• acute treatment of schizoaffective disorder as an adjunct to mood stabilizers and/or antidepressants

The most common adverse reactions (incidence ≥ 5% and at least twice that for placebo) were:

extrapyramidal symptoms, tachycardia, and akathisia in the schizophrenia trials, and extrapyramidal symptoms, somnolence, dyspepsia, constipation, weight increased, and nasopharyngitis in the schizoaffective disorder trials. 

 Centrally-acting drugs: Due to CNS effects, use caution in combination. Avoid alcohol.

• Drugs that may cause orthostatic hypotension: An additive effect may be observed when co-administered with INVEGA®. 
• Co-administration with carbamazepine decreased mean steady-state Cmax and AUC of paliperidone by approximately 37%. Adjust dose of INVEGA® if necessary based on clinical assessment. 
• Co-administration of divalproex sodium increased Cmax and AUC of paliperidone by approximately 50%. Adjust dose of INVEGA® if necessary based on clinical assessment. 

Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g. stroke, transient ischemic attack, including fatalities). INVEGA® is not approved for use in patients with dementia-related psychosis 

• Neuroleptic Malignant Syndrome : Manage with immediate discontinuation of drug and close monitoring 
• QT Prolongation: Increase in QT interval, avoid use with drugs that also increase QT interval and in patients with risk factors for prolonged QT interval 
• Tardive Dyskinesia: Discontinue drug if clinically appropriate 
• Hyperglycemia and Diabetes Mellitus: Monitor glucose regularly in patients with and at risk for diabetes 
• Hyperprolactinemia: Prolactin elevations occur and persist during chronic administration 
• Gastrointestinal Narrowing: Obstructive symptoms may result in patients with gastrointestinal disease 
• Orthostatic Hypotension and Syncope: Use with caution in patients with known cardiovascular or cerebrovascular disease and patients predisposed to hypotension 
• Leukopenia, Neutropenia, and Agranulocytosis: has been reported with antipsychotics, including INVEGA®. Patients with a history of a clinically significant low white blood cell count (WBC) or a druginduced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of INVEGA® should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors. 
• Potential for Cognitive and Motor Impairment : Use caution when operating machinery
• Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold 
• Suicide: Closely supervise high-risk patients