Invega Trinza Use In Pregnancy & Lactation

Pregnancy: Pregnancy Exposure: There is a pregnancy exposure monitoring pregnancy outcomes in women exposed to atypical antipsychotics, including INVEGA TRINZA, during pregnancy. Please report to the healthcare professional if the patient is pregnant.
Risk Summary: Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There are no available data on INVEGA TRINZA use in pregnant women to inform any drug-associated risks for birth defects or miscarriage. Paliperidone has been detected in plasma at very low levels up to 18 months after a single-dose administration of INVEGA TRINZA, and the clinical significance of INVEGA TRINZA administered before pregnancy or anytime during pregnancy is not known (see Pharmacology: Pharmacokinetics under Actions). No teratogenicity was observed when pregnant rats were injected intramuscularly with the 1-month paliperidone palmitate extended-release injectable suspension during organogenesis at doses up to 250 mg/kg, which is 3 times the maximum recommended human dose (MRHD) of 525mg paliperidone (as 819 mg paliperidone palmitate) of the 3-month paliperidone palmitate injectable suspension on mg/m² basis.
Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Clinical Considerations: Fetal/Neonatal Adverse Reactions: Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs during the third trimester of pregnancy. These symptoms have varied in severity. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. Some neonates recover within hours or days without specific treatment; others may require prolonged hospitalization.
Data: Human Data: 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, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder in neonates following in utero exposure to antipsychotics in the third trimester. 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 TRINZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Animal Data: No developmental toxicity studies were conducted with the 3-month paliperidone palmitate extended-release injectable suspension.
No treatment-related effects on the offspring were observed when pregnant rats were injected intramuscularly with 1-month paliperidone palmitate extended-release injectable suspension during the period of organogenesis at doses up to 250 mg/kg, which is 3 times the MRHD of 525 mg paliperidone (as 819 mg paliperidone palmitate) of the 3-month paliperidone palmitate extended-release injectable suspension on mg/m² basis.
No increases in fetal abnormalities were observed when paliperidone was administered orally to pregnant rats and rabbits during the period of organogenesis at doses up to 8 times the MRHD of 12 mg/day of oral paliperidone on mg/m² basis.
In rat reproduction studies with risperidone, which is extensively converted to paliperidone in rats and humans, pup deaths increased at oral doses, which are less than the MRHD of risperidone on mg/m² basis (see RISPERDAL package insert).
Lactation: Paliperidone is present in human breast milk; however, there are insufficient data to assess the amount in human milk, the effects on the breastfed infant, or the effects on milk production. Paliperidone has been detected in plasma at very low levels up to 18 months after a single-dose administration of INVEGA TRINZA, and the clinical significance on the breastfed infant is not known (see Pharmacology: Pharmacokinetics under Actions).