INVEGA SUSTENNA® is approved for the treatment of schizoaffective disorder

Short-term Studies for Schizophrenia

Adverse reactions in the 4 short-term (9-week and 13-week) studies1*
A graph illustrating potential INVEGA SUSTENNA® (paliperidone palmitate) adverse reactions and other tolerability information in short-term studies

*Occurring in ≥5% of patients treated with INVEGA SUSTENNA®.1

Initial deltoid injection of 234 mg followed by 39 mg, 156 mg, or 234 mg every 4 weeks by deltoid or gluteal injection. Other dose groups (39 mg, 78 mg, and 156 mg) are from studies involving only gluteal injection.1

In the 5 pivotal schizophrenia trials for INVEGA SUSTENNA® (1 long-term study and 4 short-term studies), the most common adverse reactions (incidence ≥5% and occurring at least twice as often as placebo) were injection-site reactions, somnolence/sedation, dizziness, akathisia, and extrapyramidal disorder.1

Tardive Dyskinesia1
The risk of developing tardive dyskinesia (TD) appears to increase with duration of treatment and total cumulative dose but can develop after relatively brief treatment at low doses
. Elderly female patients appeared to be at an increased risk for TD. If signs and symptoms of TD appear in a patient treated with INVEGA SUSTENNA®, drug discontinuation should be considered.

Weight Change in Short-term Studies

Mean change in body weight from 4 placebo-controlled, 9- to 13-week, fixed-dose studies1
A graph depicting potential weight change in INVEGA SUSTENNA® (paliperidone palmitate) in short-term studies

Initial deltoid injection of 234 mg followed by 39 mg, 156 mg, or 234 mg every 4 weeks by deltoid or gluteal injection. Other dose groups (39 mg, 78 mg, and 156 mg) are from studies involving only gluteal injection.1

Significant weight gain has been reported with the use of INVEGA SUSTENNA®. Clinical monitoring of weight gain is recommended.1

Study Design

Results from 4 placebo-controlled (one 9-week and three 13-week), fixed-dose studies of adult patients experiencing an acute exacerbation of schizophrenia.1

Weight Gain

Weight gain ≥7% of total body weight was reported in 3.3% of placebo-treated patients compared with 6.0% (39 mg), 8.9% (78 mg), 9.0% (156 mg), 5.8% (234 mg/39 mg), 8.3% (234 mg/156 mg), and 13.1% (234 mg/234 mg) of patients treated with INVEGA SUSTENNA®.1‡

Initial deltoid injection of 234 mg followed by 39 mg, 156 mg, or 234 mg every 4 weeks by deltoid or gluteal injection. Other dose groups (39 mg, 78 mg, and 156 mg) are from studies involving only gluteal injection.1

Extrapyramidal Symptoms (EPS)

A 13-week study of adult patients experiencing an acute exacerbation of schizophrenia1,2
A graph depicting potential extrapyramidal symptoms in INVEGA SUSTENNA®(paliperidone palmitate) in short-term studies

Pooled data from two 13-week, double-blind studies showed that the overall percentages of EPS-related adverse events were 10% in the placebo group and 12%, 11%, and 11% in the INVEGA SUSTENNA® 39-mg, 78-mg, and 156-mg groups, respectively.1

In a 9-week, double-blind study, the incidence of parkinsonism and akathisia was higher in the INVEGA SUSTENNA® 156-mg group (18% and 11%, respectively) than in the INVEGA SUSTENNA® 78-mg group (9% and 5%, respectively) and placebo group (7% and 4%, respectively).1

The results across all phases of the maintenance trial exhibited comparable findings.1

Study Design

Results from a double-blind, randomized, placebo-controlled, fixed-dose, 13-week study of adult inpatients experiencing an acute exacerbation of schizophrenia. Patients were randomized to receive placebo or a 234-mg deltoid injection initiation dose on day 1, followed by a 39-mg, 156-mg, or 234-mg dose in either the deltoid or gluteal muscle on day 8, and once monthly thereafter.1,2

Lipids

Cholesterol

Cholesterol: From 4 placebo-controlled, 9- to 13-week, fixed-dose studies1
A chart illustrating cholesterol levels in INVEGA SUSTENNA®(paliperidone palmitate) in short-term studies

Initial deltoid injection of 234 mg followed by 39 mg, 156 mg, or 234 mg every 4 weeks by deltoid or gluteal injection. Other dose groups (39 mg, 78 mg, and 156 mg) are from studies involving only gluteal injection.1

LDL

LDL: From 4 placebo-controlled, 9- to 13-week, fixed-dose studies1
A chart illustrating LDL cholesterol levels in INVEGA SUSTENNA®(paliperidone palmitate) in short-term studies

Initial deltoid injection of 234 mg followed by 39 mg, 156 mg, or 234 mg every 4 weeks by deltoid or gluteal injection. Other dose groups (39 mg, 78 mg, and 156 mg) are from studies involving only gluteal injection.1

HDL

HDL: From 4 placebo-controlled, 9- to 13-week, fixed-dose studies1
A chart depicting HDL cholesterol levels in INVEGA SUSTENNA®(paliperidone palmitate) in short-term studies

Initial deltoid injection of 234 mg followed by 39 mg, 156 mg, or 234 mg every 4 weeks by deltoid or gluteal injection. Other dose groups (39 mg, 78 mg, and 156 mg) are from studies involving only gluteal injection.1

Triglycerides

Triglycerides: From 4 placebo-controlled, 9- to 13-week, fixed-dose studies1
A chart illustrating triglycerides cholesterol levels in INVEGA SUSTENNA®(paliperidone palmitate) in short-term studies

Initial deltoid injection of 234 mg followed by 39 mg, 156 mg, or 234 mg every 4 weeks by deltoid or gluteal injection. Other dose groups (39 mg, 78 mg, and 156 mg) are from studies involving only gluteal injection.1

Dyslipidemia
Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.1

Study Design

Results from 4 placebo-controlled (one 9-week and three 13-week), fixed-dose studies of adult patients experiencing an acute exacerbation of schizophrenia.1

References: 1. INVEGA SUSTENNA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; March 2018. 2. Pandina GJ, Lindenmayer J-P, Lull J, et al. A randomized, placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia. J Clin Psychopharmacol. 2010;30(3):235-244.

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