INVEGA® (paliperidone) Extended-Release Tablets are indicated for the acute and maintenance treatment of schizophrenia [see Clinical Studies].

Recommended Dosing

The recommended dose of INVEGA® (paliperidone) Extended-Release Tablets 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 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, 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 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.

Administration Instructions

INVEGA® can be taken with or without food. Clinical trials establishing the safety and efficacy of INVEGA® were carried out in patients without regard to food intake.

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

Renal Impairment

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 maximum recommended dose is 6 mg once daily. 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 CLINICAL PHARMACOLOGY]

Hepatic Impairment

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.

Elderly

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: 3 mg (white), 6 mg (beige), and 9 mg (pink). All tablets are capsule shaped and are imprinted with either "PALI 3", "PALI 6", or "PALI 9".

INVEGA® (paliperidone) Extended-Release Tablets are available in the following strengths and packages. All tablets are capsule-shaped.

3 mg tablets are white and imprinted with "PALI 3", and are available in bottles of 30 (NDC 50458-550-01), bottles of 350 (NDC 50458-550-02), and hospital unit dose packs of 100 (NDC 50458-550-10).

6 mg tablets are beige and imprinted with "PALI 6", and are available in bottles of 30 (NDC 50458-551-01), bottles of 350 (NDC 50458-551-02), and hospital unit dose packs of 100 (NDC 50458-551-10).

9 mg tablets are pink and imprinted with "PALI 9", and are available in bottles of 30 (NDC 50458-552-01), bottles of 350 (NDC 50458-552-02), and hospital unit dose packs of 100 (NDC 50458-552-10).

Storage and Handling

Store up to 25ºC (77ºF); excursions permitted to 15 - 30ºC (59 - 86ºF) [see USP Controlled Room Temperature]. Protect from moisture.

Keep out of reach of children.

INVEGA® (paliperidone) Extended-Release Tablets Manufactured by: ALZA Corporation, Mountain View, CA 94043. Distributed by: Janssen, L.P. Titusville, NJ 08560. OROS is a registered trademark of ALZA Corporation. Revised: February 2008. FDA Rev date: 5/16/2008

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