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Treatment of schizophrenia, including acute treatment and recurrence prevention: Adults (≥ 18 Years of Age): The recommended dose of INVEGA for the treatment of schizophrenia in adults is 6 mg once daily, administered in the morning. Initial dose titration is not required. Although it has not been systematically established that doses above 6 mg have additional benefit, there was a general trend for greater effects with higher doses. This must be weighed against the dose-related increase in adverse effects. Thus, some patients may benefit from higher doses, up to 12 mg/day, and for some patients, a lower dose of 3 mg/day may be sufficient. Dose increases above 6 mg/day should be made only after clinical reassessment and generally should occur at intervals of more than 5 days. When dose increases are indicated, small increments of 3 mg/day are recommended. The maximum recommended dose is 12 mg/day.
In a longer-term study, INVEGA has been shown to be effective in delaying time to relapse in patients with schizophrenia who were stabilized on INVEGA for 6 weeks (see Pharmacology: Pharmacodynamics: Clinical Efficacy under Actions). INVEGA should be prescribed at the lowest effective dose for maintaining clinical stability and the physician should periodically reevaluate the long-term usefulness of the drug in individual patients.
Adolescents population: Schizophrenia: The recommended starting dose of INVEGA for the treatment of schizophrenia in adolescents 15 - 17 years old is 3 mg once daily, administered in the morning.
Adolescents weighing < 51 kg: the maximum recommended daily dose of INVEGA is 6 mg.
Adolescents weighing ≥ 51 kg: the maximum recommended daily dose of INVEGA is 12 mg.
Dosage adjustment, if indicated, should occur only after clinical reassessment based on the individual need of the patient. When dose increases are indicated, increments of 3 mg/day are recommended and generally should occur at intervals of 5 days or more. The safety and efficacy of INVEGA in the treatment of schizophrenia in adolescents between 12 and 14 years old has not been established.
Currently available data are described in Adverse Reactions and Pharmacology: Pharmacodynamics under Actions but no recommendation on a posology can be made. There is no relevant use of INVEGA in children aged less than 12 years.
Treatment of acute exacerbations of schizoaffective disorder as monotherapy and in combination with antidepressants and/or mood stabilizers (lithium and valproate): Schizoaffective Disorder: The recommended dose of INVEGA for the treatment of schizoaffective disorder is 6 mg once daily, administered in the morning.
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. A general trend for greater effects was seen with higher doses.
This trend must be weighed against dose-related increase in adverse reactions. Dosage adjustment, if indicated, should occur only after clinical reassessment. When dose increases are indicated, increment of 3 mg/day are recommended and generally should occur at intervals on more than 4 days.The maximum recommended dose is 12 mg/day.
Special populations: Adolescents and children: Safety and effectiveness of INVEGA for the treatment of schizophrenia in patients < 12 years of age have not been established. Safety and effectiveness of INVEGA for the treatment of schizoaffective disorder in patients < 18 years of age have not been studied.
Elderly: Dosing recommendations for elderly patients with normal renal function (≥ 80 mL/min) are the same as for adults with normal renal function (see Dosage and Administration above). However, because elderly patients may have diminished renal function, dose adjustments may be required according to their renal function status. (See Renal impairment as follows.)
Renal impairment: For patients with mild renal impairment (creatinine clearance ≥ 50 to < 80 mL/min), the recommended initial dose is 3 mg once daily. The dose may be increased to 6 mg once daily based on clinical response and tolerability.
For patients with moderate to severe renal impairment (creatinine clearance ≥ 10 to < 50 mL/min), the recommended dose of INVEGA is 3 mg every other day, which may then be increased to 3 mg once daily after clinical reassessment. As INVEGA has not been studied in patients with creatinine clearance < 10 mL/min, use is not recommended in such patients.
Hepatic impairment: No dose adjustment is required in patients with mild to moderate hepatic impairment.
INVEGA has not been studied in patients with severe hepatic impairment.
Other populations: No dose adjustment for INVEGA is recommended based on gender, race, or smoking status. (For pregnant women and nursing mothers, see Use in Pregnancy & Lactation.)
Switching to Other Antipsychotic Agents: There are no systematically collected data to specifically address switching patients from INVEGA to other antipsychotic agents. Due to different pharmacodynamic and pharmacokinetic profiles among antipsychotic products, supervision by a clinician is needed when switching to another antipsychotic product is considered medically appropriate.
Administration: INVEGA is for oral administration and can be administered with or without food.
INVEGA must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed. The medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate. The tablet shell, along with insoluble core components, is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet.
