Paliperidone

PALIPERIDONE- paliperidone tablet, film coated, extended release
Actavis Pharma, Inc.

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Paliperidone e xtended-release t ablets are not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )] .

1 INDICATIONS AND USAGE

1.1 Schizophrenia

Paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see Clinical Studies ( 14.1)].

The efficacy of paliperidone 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.

1.2 Schizoaffective Disorder

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 ( 14.2)].

The efficacy of paliperidone in schizoaffective disorder was established in two 6-week trials in adults.

2 DOSAGE AND ADMINISTRATION

2.1 Schizophrenia

Adults

The recommended dose of 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, paliperidone has been shown to be effective in delaying time to relapse in patients with schizophrenia who were stabilized on paliperidone for 6 weeks [see Clinical Studies ( 14)]. Paliperidone extended-release tablets 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 to 17 years of age)

The recommended starting dose of paliperidone extended-release tablets for the treatment of schizophrenia in adolescents 12 to 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.

2.2 Schizoaffective Disorder

The recommended dose of 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.

2.3 Administration Instructions

Paliperidone extended-release tablets can be taken with or without food.

Paliperidone extended-release tablets 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.

2.4 Use with Risperidone

Concomitant use of paliperidone 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 paliperidone.

2.5 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 greater than or equal to 50 mL/min to less than 80 mL/min), the recommended initial dose of paliperidone extended-release tablets 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 greater than or equal to 10 mL/min to less than 50 mL/min), the recommended initial dose of paliperidone extended-release tablets is 1.5 mg once daily, which may be increased to a maximum of 3 mg once daily after clinical reassessment. As paliperidone extended-release tablets have not been studied in patients with creatinine clearance below 10 mL/min, use is not recommended in such patients [ s ee Clinical Pharmacology ( 12.3)] .

Hepatic Impairment
For patients with mild to moderate hepatic impairment, (Child-Pugh Classification A and B), no dose adjustment is recommended [see Clinical Pharmacology ( 12.3)]. Paliperidone extended-release tablets have 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 less than 50 mL/min), the maximum recommended dose of paliperidone extended-release tablets are 3 mg once daily [see Renal Impairment above].

3 DOSAGE FORMS AND STRENGTHS

Paliperidone extended-release tablets, 1.5 mg are available as beige, round, film-coated tablets imprinted with “WPI” on one side and “1.5” on the other side.

Paliperidone extended-release tablets, 3 mg are available as white to off-white, round, film-coated tablets imprinted with “WPI” on one side and “3” on the other side.

Paliperidone extended-release tablets, 6 mg are available as reddish-brown, round, film-coated tablets imprinted with “WPI” on one side and “6” on the other side.

Paliperidone extended-release tablets, 9 mg are available as blue, round, film-coated tablets imprinted with “WPI” on one side and “9” on the other side.

4 CONTRAINDICATIONS

Paliperidone is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the paliperidone extended-release tablet formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone is a metabolite of risperidone.

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