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U.S. Department of Health and Human Services


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Invega Sustenna (Paliperidone Palmitrate) Extended-release Injectable Suspension

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2012

Summary View



Increased Mortality in Elderly Patients with Dementia-Related Psychosis
  • Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients…
  • Like other drugs that antagonize dopamine D2 receptors, paliperidone elevates prolactin levels and the elevation persists during chronic administration. Paliperidone has a prolactin-elevating effect similar to that seen with risperidone, a drug that is associated with higher levels of prolactin than other antipsychotic drugs…


  • Hyperprolactinemia
Postmarketing Experience
  • or establish a causal relationship to drug exposure…


  • Risk Summary - Adequate and well controlled studies with INVEGA® SUSTENNA® have not been conducted in pregnant women. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Invega Sustenna should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
Clinical Considerations
Fetal/Neonatal Adverse Reactions
  • Monitor neonates exhibiting extrapyramidal or withdrawal symptoms…
Human Data
  • following in utero exposure to antipsychotics in the third trimester.
Animal Data
  • There were no treatment-related effects on the offspring when pregnant rats were injected intramuscularly with paliperidone palmitate during the period of organogenesis at doses up to 250 mg/kg, which is 10 times the maximum recommended human 234 mg dose of Invega Sustenna on a mg/m2 body surface area basis…
Nursing Mothers
  • Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Renal Impairment
  • Dose reduction is recommended for patients with mild renal impairment (creatinine clearance ≥ 50 mL/min to < 80 mL/min)
Patients with Parkinson’s Disease or Lewy Body Dementia
  • Patients with Parkinson’s Disease or Dementia with Lewy Bodies can experience increased sensitivity to Invega Sustenna. Manifestations can include confusion, obtundation, postural instability with frequent falls, extrapyramidal symptoms, and clinical features consistent with neuroleptic malignant syndrome.