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The efficacy of INVEGA® in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults.
INVEGA® (paliperidone) Extended-Release Tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see Clinical Studies].
The efficacy of INVEGA® in schizoaffective disorder was established in two 6-week trials in adults.
DOSAGE AND ADMINISTRATION
The recommended dose of INVEGA® (paliperidone) Extended-Release Tablets for the treatment of schizophrenia in adults is 6 mg administered once daily. 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 reactions. 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, 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 Clinical Studies]. 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 (12-17 years of age)
The recommended starting dose of INVEGA® (paliperidone) Extended-Release Tablets for the treatment of schizophrenia in adolescents 12-17 years of age is 3 mg administered once daily. Initial dose titration is not required. Dose increases, if considered necessary, should be made only after clinical reassessment and should occur at increments of 3 mg/day at intervals of more than 5 days. Prescribers should be mindful that, in the adolescent schizophrenia study, there was no clear enhancement to efficacy at the higher doses, i.e., 6 mg for subjects weighing less than 51 kg and 12 mg for subjects weighing 51 kg or greater, while adverse events were dose-related.
The recommended dose of INVEGA® (paliperidone) Extended-Release Tablets for the treatment of schizoaffective disorder in adults is 6 mg administered once daily. 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. Dose increases, if indicated, generally should occur at intervals of more than 4 days. When dose increases are indicated, increments of 3 mg/day are recommended. The maximum recommended dose is 12 mg/day.
INVEGA® can be taken with or without food.
INVEGA® must be swallowed whole with the aid of liquids. Tablets should 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.
Use With Risperidone
Concomitant use of INVEGA® with risperidone has not been studied. Since paliperidone is the major active metabolite of risperidone, consideration should be given to the additive paliperidone exposure if risperidone is coadministered with INVEGA® .
Dosage In Special Populations
Dosing must be individualized according to the patient's renal function status. For patients with mild renal impairment (creatinine clearance ≥ 50 mL/min to < 80 mL/min), the recommended initial dose of INVEGA® is 3 mg once daily. The dose may then be increased to a maximum of 6 mg once daily based on clinical response and tolerability. For patients with moderate to severe renal impairment (creatinine clearance ≥ 10 mL/min to < 50 mL/min), the recommended initial dose of INVEGA® is 1.5 mg once daily, which may be increased to a maximum of 3 mg once daily after clinical reassessment. As INVEGA® has not been studied in patients with creatinine clearance below 10 mL/min, use is not recommended in such patients. [See CLINICAL PHARMACOLOGY]
For patients with mild to moderate hepatic impairment, (Child-Pugh Classification A and B), no dose adjustment is recommended [see CLINICAL PHARMACOLOGY]. INVEGA® has not been studied in patients with severe hepatic impairment.
Because elderly patients may have diminished renal function, dose adjustments may be required according to their renal function status. In general, recommended dosing for elderly patients with normal renal function is the same as for younger adult patients with normal renal function. For patients with moderate to severe renal impairment (creatinine clearance 10 mL/min to < 50 mL/min), the maximum recommended dose of INVEGA® is 3 mg once daily [see Renal Impairment above].
Dosage Forms And Strengths
INVEGA® Extended-Release Tablets are available in the following strengths and colors: 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink). All tablets are capsule shaped and are imprinted with either “PAL 1.5”, “PAL 3”, “PAL 6”, or “PAL 9”.
INVEGA® (paliperidone) Extended-Release Tablets are available in the following strengths and packages. All tablets are capsule-shaped.
1.5 mg tablets are orange-brown and imprinted with “PAL 1.5”, and are available in bottles of 30 (NDC 50458-554-01).
3 mg tablets are white and imprinted with “PAL 3”, and are available in bottles of 30 (NDC 50458-550-01) and hospital unit dose packs of 100 (NDC 50458-550-10).
6 mg tablets are beige and imprinted with “PAL 6”, and are available in bottles of 30 (NDC 50458-551-01) and hospital unit dose packs of 100 (NDC 50458-551-10).
9 mg tablets are pink and imprinted with “PAL 9”, and are available in bottles of 30 (NDC 50458-552-01) and hospital unit dose packs of 100 (NDC 50458-552-10).
Storage And Handling
Store up to 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
Keep out of reach of children.
Manufactured by: ALZA Corporation Vacaville, CA 95688 OR Janssen Cilag Manufacturing, LLC Gurabo, Puerto Rico 00778. Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560
Last reviewed on RxList: 5/19/2014
This monograph has been modified to include the generic and brand name in many instances.
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