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Pregnancy Category C.

There are no adequate and well controlled studies of Paliperidone (Invega) in pregnant women.

Use of first generation antipsychotic drugs during the last trimester of pregnancy has been associated with extrapyramidal symptoms in the neonate. These symptoms are usually self-limited. It is not known whether paliperidone, when taken near the end of pregnancy, will lead to similar neonatal signs and symptoms.

In animal reproduction studies, there were no increases in fetal abnormalities when pregnant rats and rabbits were treated during the period of organogenesis with up to 8 times the maximum recommended human dose of paliperidone (on a mg / m2 basis).

In rat reproduction studies with risperidone, which is extensively converted to paliperidone in rats and humans, there were increases in pup deaths seen at oral doses which are less than the maximum recommended human dose of risperidone on a mg / m2 basis (see risperidone package insert).

Non-teratogenic Effects

Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypotonia, hypertonia, tremor, somnolence, respiratory distress, and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.

Invega (Paliperidone) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Paliperidone is excreted in human breast milk. The known benefits of breastfeeding should be weighed against the unknown risks of infant exposure to paliperidone.

Pediatric Use

Safety and effectiveness of Paliperidone (Invega) in the treatment of schizophrenia were evaluated in 150 adolescent subjects 12-17 years of age with schizophrenia who received Invega in the dose range of 1.5 mg to 12 mg per day in a 6-week, double-blind, placebo-controlled trial.

Safety and effectiveness of Invega (Paliperidone) for the treatment of schizophrenia in patients < 12 years of age have not been established. Safety and effectiveness of this drug for the treatment of schizoaffective disorder in patients < 18 years of age have not been studied.

In a study in which juvenile rats were treated with oral paliperidone from days 24 to 73 of age, a reversible impairment of performance in a test of learning and memory was seen, in females only, with a no-effect dose of 0.63 mg / kg per day, which produced plasma levels (AUC) of paliperidone similar to those in adolescents. No other consistent effects on neurobehavioral or reproductive development were seen up to the highest dose tested (2.5 mg / kg per day), which produced plasma levels of paliperidone 2-3 times those in adolescents.

Juvenile dogs were treated for 40 weeks with oral risperidone, which is extensively metabolized to paliperidone in animals and humans, at doses of 0.31, 1.25, or 5 mg / kg per day. Decreased bone length and density were seen with a no-effect dose of 0.31 mg / kg per day, which produced plasma levels (AUC) of risperidone plus paliperidone which were similar to those in children and adolescents receiving the maximum recommended human dose of risperidone. In addition, a delay in sexual maturation was seen at all doses in both males and females. The above effects showed little or no reversibility in females after a 12-week drug-free recovery period.

The long-term effects of Invega (Paliperidone) on growth and sexual maturation have not been fully evaluated in children and adolescents.

Geriatric Use

The safety, tolerability, and efficacy of Paliperidone (Invega) were evaluated in a 6-week placebo-controlled study of 114 elderly subjects with schizophrenia (65 years of age and older, of whom 21 were 75 years of age and older). In this study, subjects received flexible doses of Invega (3 mg to 12 mg once daily). In addition, a small number of subjects 65 years of age and older were included in the 6-week placebo-controlled studies in which adult schizophrenic subjects received fixed doses of Invega (3 mg to 15 mg once daily). There were no subjects >= 65 years of age in the schizoaffective disorder studies.

Overall, of the total number of subjects in schizophrenia clinical studies of Invega (n = 1796), including those who received this medication or placebo, 125 (7.0%) were 65 years of age and older and 22 (1.2%) were 75 years of age and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney and clearance is decreased in patients with moderate to severe renal impairment, who should be given reduced doses. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Renal Impairment

Dosing must be individualized according to the patient's renal function status.

Hepatic Impairment

No dosage adjustment is required in patients with mild to moderate hepatic impairment. Invega (Paliperidone) has not been studied in patients with severe hepatic impairment.

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