SUMMARY

Most Common Adverse Reactions:

• The most common (at least 5% in any INVEGA SUSTENNA group) and likely drug-related (adverse events for which the drug rate is at least twice the placebo rate) adverse reactions from the double-blind, placebo-controlled trials in subjects with schizophrenia were injection site reactions, somnolence/sedation, dizziness, akathisia, and extrapyramidal disorder. No occurrences of adverse events reached this threshold in the long-term double-blind, placebo-controlled study in subjects with schizoaffective disorder.¹
• In the schizoaffective disorder clinical trial, adverse reactions that occurred more frequently in the INVEGA SUSTENNA group than the placebo group (a 2% difference or more between groups) were weight increased, nasopharyngitis, headache, hyperprolactinemia, and pyrexia.¹

Dose-Related Adverse Reactions:

• Based on the pooled data from the four fixed-dose, double-blind, placebo-controlled trials in subjects with schizophrenia, among the adverse reactions that occurred at ≥2% incidence in the subjects treated with INVEGA SUSTENNA, only akathisia increased with dose. Hyperprolactinemia also exhibited a dose relationship but did not occur at ≥2% incidence in INVEGA SUSTENNA-treated subjects from the four fixed-dose studies.¹

Discontinuations Due to Adverse Events:

• The percentage of subjects who discontinued due to adverse events in the four fixed-dose, double-blind, placebo-controlled schizophrenia trials were similar for INVEGA SUSTENNA- and placebo-treated subjects.¹
• The percentage of subjects who discontinued due to adverse events in the open-label period of the long-term schizoaffective disorder study was 7.5%. During the double-blind, placebo-controlled period of that study, the percentages of subjects who discontinued due to adverse events were 5.5% and 1.8% in INVEGA SUSTENNA- and placebo-treated subjects, respectively.¹

Demographic Differences:

• An examination of population subgroups in the double-blind placebo-controlled trials did not reveal any evidence of differences in safety on the basis of age, gender, or race alone; however, there were few subjects ≥65 years of age.¹

Specific Adverse Events:

• For questions regarding specific adverse events, please contact Medical Information at 1-800-JANSSEN (1-800-526-7736).

DOSAGE STRENGTH INFORMATION

Doses of paliperidone palmitate extended-release injectable suspension may be expressed in milligram equivalents of paliperidone (active moiety) or milligrams of paliperidone palmitate. Dosage information in this response has been converted to mg of paliperidone palmitate to reflect the commercially available dosage strengths in the United States. The conversion factor from mg eq. to mg is 1.56.

• INVEGA SUSTENNA doses expressed as 39, 78, 117, 156, and 234 mg of paliperidone palmitate are equal to 25, 50, 75, 100, and 150 mg eq. of paliperidone, respectively.

PRODUCT LABELING

Please refer to the following sections of the Full Prescribing Information¹ which are relevant to your inquiry: BOXED WARNING, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS.

Boxed Warning

Increased Mortality in Elderly Patients with Dementia-Related Psychosis¹
-Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

-INVEGA SUSTENNA is not approved for use in patients with dementia-related psychosis.

Contraindications

INVEGA SUSTENNA is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the INVEGA SUSTENNA formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been observed in patients treated with risperidone and paliperidone. Paliperidone palmitate is converted to paliperidone, which is a metabolite of risperidone.¹

Warnings and Precautions

Please refer to the Full Prescribing Information¹ for detailed information regarding the Boxed Warning and Warnings and Precautions for INVEGA SUSTENNA.

• Increased Mortality in Elderly Patients with Dementia-Related Psychosis
• Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis
• Neuroleptic Malignant Syndrome
• QT Prolongation
• Tardive Dyskinesia
• Metabolic Changes
  • Hyperglycemia and Diabetes Mellitus
  • Dyslipidemia
  • Weight Gain
• Orthostatic Hypotension and Syncope
• Falls
• Leukopenia, Neutropenia, and Agranulocytosis
• Hyperprolactinemia
• Potential for Cognitive and Motor Impairment
• Seizures
• Dysphagia
• Priapism
• Disruption of Body Temperature Regulation

Adverse Reactions

Please refer to the ADVERSE REACTIONS section of the Full Prescribing Information¹ for additional information.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 27 March 2024.