Paliperidone palmitate

(Invega Sustenna®)

Paliperidone palmitate

Drug updated on 9/5/2024

Dosage FormInjection (intramuscular; 39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL, or 234 mg/1.5 mL)
Drug ClassAtypical antipsychotics
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for treatment of schizophrenia in adults.
  • Indicated for treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants.

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Summary
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  • Invega Sustenna (paliperidone palmitate) is indicated for the treatment of schizophrenia in adults and for the treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants.
  • This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
  • Children and Adolescents with Schizophrenia Spectrum Disorders (SSD): The use of long-acting injectable antipsychotics (LAIAs), including paliperidone palmitate (PP), was associated with symptom improvement in all reviewed studies.
  • Adults with Acute Symptoms of Schizophrenia: Paliperidone palmitate (PP) and paliperidone extended-release (PAL-ER) significantly reduced the Positive and Negative Syndrome Scale (PANSS-T) scores by week 6, outperforming placebo with no significant differences between PP and PAL-ER.
  • Patients with Schizophrenia or Bipolar Disorder: Paliperidone palmitate (PP) demonstrated a significant reduction in PANSS scores, indicating clinical effectiveness in these patient populations.
  • LAIAs, including paliperidone palmitate (PP), showed acceptable safety and tolerability in children and adolescents with schizophrenia spectrum disorders (SSD), though specific adverse effects were not detailed.
  • In adults with acute symptoms of schizophrenia, both PP and paliperidone extended-release (PAL-ER) increased blood prolactin levels compared with placebo, with PAL-ER causing a significantly higher increase. Additionally, PP was associated with significant adverse outcomes, including extrapyramidal disorder, tardive dyskinesia, increased weight, and mild to moderate gynecomastia in patients with schizophrenia or bipolar disorder.
  • The evidence discusses population types and subgroup considerations in four groups: children and adolescents with SSD (12-17 years, no studies for <12 years), adults with acute symptoms of schizophrenia (gender-specific data for prolactin increases), early psychosis patients (first episode or ≤5 years illness, no specific subgroup findings), and patients with schizophrenia or bipolar disorder (no specific subgroup findings). Further studies are suggested, particularly for children under 12 years and early psychosis patients.