HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use INVEGA ® safely and effectively. See full prescribing information for INVEGA ®.
INVEGA ® (paliperidone) Extended-Release Tablets
Initial U.S. Approval: 2006
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. (5.1)
RECENT MAJOR CHANGES
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Indications and Usage, Schizoaffective Disorder (1.2) |
July 2009 |
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Dosage and Administration, Schizoaffective Disorder (2.2) |
July 2009 |
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Dosage and Administration, Dosage in Special Populations, Renal Impairment (2.5) |
July 2009 |
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Warnings and Precautions, Leukopenia, Neutropenia, and Agranulocytosis (5.10) |
July 2009 |
INDICATIONS AND USAGE
INVEGA® is an atypical antipsychotic agent indicated for the
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acute and maintenance treatment of schizophrenia (1.1)
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acute treatment of schizoaffective disorder as monotherapy (1.2)
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acute treatment of schizoaffective disorder as an adjunct to mood stabilizers and/or antidepressants (1.2)
DOSAGE AND ADMINISTRATION
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For schizophrenia: 6 mg extended-release tablet administered in the morning with or without food. Initial dose titration is not required. Some patients may benefit from either higher doses up to 12 mg/day, or a lower dose of 3 mg/day. If clinical assessment warrants, increase the dose at increments of 3 mg/day at intervals of more than 5 days. Maximum recommended dose is 12 mg/day. (2.1)
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For schizoaffective disorder: 6 mg extended-release tablet administered in the morning with or without food. Initial dose titration is not required. Some patients may benefit from lower or higher doses within the recommended dose range of 3 to 12 mg once daily. If clinical assessment warrants, increase the dose at increments of 3 mg/day at intervals of more than 4 days. Maximum recommended dose is 12 mg/day. (2.2)
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Tablet should be swallowed whole and should not be chewed, divided, or crushed. (2.3)
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Patients may notice tablet-shaped shell in their stool. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 1.5 mg, 3 mg, 6 mg, and 9 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to paliperidone, risperidone, or to any components in the formulation (4)
WARNINGS AND PRECAUTIONS
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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 (5.2)
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Neuroleptic Malignant Syndrome : Manage with immediate discontinuation of drug and close monitoring (5.3)
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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 (5.4)
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