Drug updated on 4/17/2024
| Dosage Form | Injection (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 Class | Atypical 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.
Summary
- Paliperidone palmitate (Invega Sustenna) is indicated for the treatment of schizophrenia and schizoaffective disorder in adults, either as monotherapy or adjunct therapy. It has shown effectiveness across various population types including adults with acute symptoms of schizophrenia, children, and adolescents with Schizophrenia Spectrum Disorders (SSD), and early psychosis patients.
- Four systematic reviews/meta-analyses were reviewed to compare the safety and effectiveness of Invega Sustenna against other antipsychotics like Risperidone and Paliperidone extended-release (PAL-ER).
- A study focusing on children and adolescents with SSD suggested good effectiveness of long-acting injectable antipsychotics such as Paliperidone Palmitate. However, studies on children under 12 were absent.
- For adults experiencing acute symptoms of schizophrenia, Invega Sustenna was found to be a viable option, comparing favorably against PAL-ER, especially at doses of 100 or 150 mg equivalent. Both drugs increased blood prolactin levels, but PAL-ER raised it more significantly than PP.
- In early psychosis patient populations, long-acting injectables, including Invega Sustenna, showed potential benefits over oral antipsychotic treatments by improving adherence, reducing relapse rates, and enhancing symptom management.
- A comparative study using individual participant data revealed modest beneficial effects on PANSS score when using Risperidone or any form of paliperidone including Invega Sustenna. However, significant findings emerged regarding harms not reported in journal publications, which included risks associated with extrapyramidal disorders, tardive dyskinesia, and weight gain. Clinical reports also revealed more adverse events compared to journal publications, emphasizing the need for a comprehensive understanding of drug safety from complete trial data.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Invega Sustenna (paliperidone palmitate) Prescribing Information. | 2022 | Janssen Pharmaceuticals, Inc., Titusville, NJ |