What is the recommended starting dose of Invega (paliperidone) Extended Release (ER) for adults with schizophrenia?

Starting Dose of Invega (Paliperidone ER)

For adults with schizophrenia, start paliperidone ER at 6 mg once daily without initial dose titration. 1

Adult Dosing for Schizophrenia

• The FDA-approved starting dose is 6 mg once daily, administered without any initial titration period. 1
• Paliperidone ER can be taken with or without food and must be swallowed whole—never chewed, divided, or crushed. 1
• While 6 mg/day is the recommended starting dose, some patients may benefit from a lower dose of 3 mg/day if tolerability is a concern, though this should be the exception rather than the rule. 1

Dose Adjustments After Initial Treatment

• Maintain the therapeutic dose for at least 4 weeks before assessing efficacy and considering any medication changes, assuming good adherence. 2, 3
• If dose increases are needed after clinical reassessment, they should occur at intervals of more than 5 days, with increments of 3 mg/day. 1
• The maximum recommended dose is 12 mg/day, though doses above 6 mg show a dose-related increase in adverse reactions that must be weighed against potential additional benefit. 1

Adolescent Dosing (Ages 12-17)

• For adolescents with schizophrenia, start at 3 mg once daily without initial titration. 1
• Dose increases should only occur after clinical reassessment, at increments of 3 mg/day with intervals of more than 5 days. 1
• In adolescent trials, higher doses (6 mg for patients <51 kg; 12 mg for patients ≥51 kg) showed no clear enhancement in efficacy but did demonstrate dose-related adverse events. 1, 4

Schizoaffective Disorder Dosing

• The recommended starting dose for schizoaffective disorder in adults is also 6 mg once daily without initial titration. 1
• The therapeutic range is 3-12 mg once daily, with dose adjustments occurring at intervals of more than 4 days if indicated. 1

Special Population Adjustments

Renal Impairment

• Mild impairment (CrCl 50-80 mL/min): Start at 3 mg once daily, with a maximum of 6 mg/day. 1
• Moderate to severe impairment (CrCl 10-50 mL/min): Start at 1.5 mg once daily, with a maximum of 3 mg/day. 1
• CrCl <10 mL/min: Use is not recommended. 1

Elderly Patients

• Use the same dosing as younger adults if renal function is normal. 1
• Adjust doses according to renal function status, as elderly patients frequently have diminished renal function. 1

Hepatic Impairment

• No dose adjustment is required for mild to moderate hepatic impairment (Child-Pugh A and B). 1

Critical Considerations

• Do not coadminister with risperidone without considering additive paliperidone exposure, as paliperidone is risperidone's major active metabolite. 1
• The extended-release formulation provides stable plasma concentrations over 24 hours, eliminating the need for initial titration that is required with many other antipsychotics. 5, 6
• Extrapyramidal symptoms occur in approximately 25% of patients at higher doses (9-12 mg/day), making the 6 mg starting dose a reasonable balance between efficacy and tolerability. 5