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Invega Sustenna (Paliperidone Palmitate) - Summary

 
 



WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. 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. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. INVEGA® SUSTENNA® (paliperidone palmitate) is not approved for the treatment of patients with dementia-related psychosis. [See Warnings and Precautions]

 

SUMMARY

INVEGA® SUSTENNA® contains paliperidone palmitate. The active ingredient, paliperidone palmitate, is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives.

INVEGA® SUSTENNA® (paliperidone palmitate) is indicated for the acute and maintenance treatment of schizophrenia in adults [see Clinical Studies].


See all Invega Sustenna indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Invega Sustenna (Paliperidone)

Retinal changes may serve as measures of brain pathology in schizophrenia
Source: Eye Health / Blindness News From Medical News Today [2015.08.19]
Schizophrenia is associated with structural and functional alterations of the visual system, including specific structural changes in the eye.

Retinal changes may serve as measures of brain pathology in schizophrenia
Source: Eye Health / Blindness News From Medical News Today [2015.08.18]
Schizophrenia is associated with structural and functional alterations of the visual system, including specific structural changes in the eye.

Can fish oil prevent schizophrenia and other psychotic disorders?
Source: Mental Health News From Medical News Today [2015.08.14]
Omega-3 fatty acids found in fish oil may prevent the onset of schizophrenia and other psychotic disorders, according to a new study.

Birth factors may predict schizophrenia in genetic subtype of schizophrenia
Source: Pregnancy / Obstetrics News From Medical News Today [2015.08.14]
Low birth weight and preterm birth appear to increase the risk of schizophrenia among individuals with a genetic condition called the 22q11.

Receptors in brain linked to schizophrenia, autism
Source: Autism News From Medical News Today [2015.08.12]
The loss of a critical receptor in a special class of inhibitory neurons in the brain may be responsible for neurodevelopmental disorders including autism and schizophrenia, according to new research...

more news >>

Published Studies Related to Invega Sustenna (Paliperidone)

Estimated medical cost reductions for paliperidone palmitate vs placebo in a randomized, double-blind relapse-prevention trial of patients with schizoaffective disorder. [2015]
CONCLUSIONS: Use of PP1M for treatment of patients with schizoaffective disorder

Paliperidone palmitate once-monthly reduces risk of relapse of psychotic, depressive, and manic symptoms and maintains functioning in a double-blind, randomized study of schizoaffective disorder. [2015]
CONCLUSIONS: Paliperidone monthly as monotherapy or adjunctive therapy

Relapse prevention study of paliperidone extended-release tablets in Chinese patients with schizophrenia. [2014]
patients with schizophrenia... CONCLUSIONS: This study confirms the findings from earlier pali ER global

Paliperidone palmitate versus risperidone long-acting injection in markedly-to-severely ill schizophrenia subjects: onset of efficacy with recommended initiation regimens. [2014]
antipsychotics in markedly-to-severely ill schizophrenia subjects... CONCLUSIONS: Using the recommended dosing regimens for PP and RLAI, both PP and

Double-blind, placebo-controlled, pilot trial of paliperidone augmentation in serotonin reuptake inhibitor-resistant obsessive-compulsive disorder. [2013]
CONCLUSIONS: These results suggest that paliperidone augmentation is well

more studies >>

Clinical Trials Related to Invega Sustenna (Paliperidone)

Paliperidone Palmitate Efficacy and Safety in Bipolar Disorder Complicated by Alcoholism [Not yet recruiting]
Our primary specific aim is to examine the efficacy of Paliperidone extended release Paliperidone Palmitate Injection (INVEGA® SUSTENNA™) compared to placebo in decreasing manic symptoms in patients with comorbid DSM-IV bipolar disorder and alcohol dependence. We hypothesize that the Paliperidone Palmitate Injection (INVEGA® SUSTENNA™) treated group will have a statistically significant advantage on improvement in manic symptoms. They will also have higher rate of treatment response and remission.

A Study to Evaluate the Response to Treatment and Safety of Flexible Dose Treatment With Extended-release Paliperidone in Patients With Schizophrenia [Recruiting]
This study will explore the efficacy and safety of flexibly dosed paliperidone ER in subjects with schizophrenia.

Hypothesis:

At the end of 12 months, flexible dose paliperidone treatment is expected to improve functionality and satisfaction of schizophrenia patients significantly as measured by PSP. The expected increase in PSP score is approximately 10-20%

Invega for the Treatment of Mania in Children and Adolescents Ages 6-17 With Bipolar Disorder [Recruiting]
This will be an 8-week open-label trial, using daily doses of paliperidone (Invega) in the treatment of children and adolescents who meet DSM-IV criteria of Bipolar I, Bipolar II, or Bipolar Spectrum Disorder. Specific hypotheses are as follows:

Hypothesis 1: Bipolar Disorder symptomatology in children and adolescents with DSM-IV Bipolar I, Bipolar II, or Bipolar Spectrum Disorder will be responsive to Invega treatment.

Hypothesis 2: Invega - associated improvement in bipolar disorder symptomatology in children

and adolescents will translate into improved functional capacities (neuropsychological, social, and occupational), as well as an increased quality of life throughout treatment.

Hypothesis 2: Invega treatment will be safe and well tolerated as reflected by a low drop out rate and absence of major side effects.

Paliperidone Extended-Release (ER) Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia [Recruiting]
Primary objective: To examine whether the switch to paliperidone ER from risperidone improves cognitive function in stabilized patients with schizophrenia.

Secondary objectives: To compare the general clinical outcomes (efficacy and safety) after switching to paliperidone ER from risperidone

A Study of Paliperidone Palmitate in Patients With Schizophrenia [Recruiting]
The primary objective of this study is to evaluate the efficacy of paliperidone palmitate as compared with placebo in patients with schizophrenia. Secondary objectives of this study are to evaluate the safety of paliperidone palmitate; to evaluate the improvement in global

symptoms as measured by the Clinical Global Impression - Severity (CGI-S) associated with

the use of paliperidone palmitate compared with placebo; and to explore the pharmacokinetics of paliperidone palmitate through pharmacokinetic sampling.

more trials >>

Reports of Suspected Invega Sustenna (Paliperidone) Side Effects

Drug Dose Omission (179)Device Leakage (78)Drug Ineffective (77)Weight Increased (72)Product Quality Issue (61)Condition Aggravated (53)Psychotic Disorder (48)Inappropriate Schedule of Drug Administration (47)Injection Site Pain (47)Hospitalisation (44)more >>


Page last updated: 2015-08-19

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