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INVEGA: ADVERSE REACTIONS
Overall Adverse Reaction Profile
The following adverse reactions are discussed in more detail in other sections of the labeling:
Increased mortality in elderly patients with dementia-related psychosis
Neuroleptic malignant syndrome
Cerebrovascular adverse reactions, including stroke, in elderly patients with dementia-related psychosis
Orthostatic hypotension and syncope
Potential for gastrointestinal obstruction
Leukopenia, neutropenia, and agranulocytosis
Potential for cognitive and motor impairment
Thrombotic thrombocytopenic purpura (TTP)
Disruption of body temperature regulation
Increased sensitivity in patients with Parkinson's disease or those with dementia with Lewy bodies
Diseases or conditions that could affect metabolism or hemodynamic responses
The most common adverse reactions in clinical trials in adult subjects with schizophrenia (reported in 5% or more of subjects treated with Invega (Paliperidone) and at least twice the placebo rate in any of the dose groups) were extrapyramidal symptoms, tachycardia, and akathisia. The most common adverse reactions in clinical trials in adult patients with schizoaffective disorder (reported in 5% or more of subjects treated with Paliperidone (Invega) and at least twice the placebo rate) were extrapyramidal symptoms, somnolence, dyspepsia, constipation, weight increased, and nasopharyngitis.
The most common adverse reactions that were associated with discontinuation from clinical trials in adult subjects with schizophrenia (causing discontinuation in 2% of Invega-treated subjects) were nervous system disorders. The most common adverse reactions that were associated with discontinuation from clinical trials in adult subjects with schizoaffective disorder were gastrointestinal disorders, which resulted in discontinuation in 1% of Invega-treated subjects.
The safety of Invega (Paliperidone) was evaluated in 1205 adult subjects with schizophrenia who participated in three placebo-controlled, 6-week, double-blind trials, of whom 850 subjects received this medication at fixed doses ranging from 3 mg to 12 mg once daily. The information presented in this section was derived from pooled data from these three trials. Additional safety information from the placebo-controlled phase of the long-term maintenance study, in which subjects received Invega at daily doses within the range of 3 mg to 15 mg (n=104), is also included.
The safety of Invega (Paliperidone) was evaluated in 150 adolescent subjects 12-17 years of age with schizophrenia who received this drug in the dose range of 1.5 mg to 12 mg per day in a 6-week, double-blind, placebo-controlled trial.
The safety of Paliperidone (Invega) was also evaluated in 622 adult subjects with schizoaffective disorder who participated in two placebo-controlled, 6-week, double-blind trials. In one of these trials, 206 subjects were assigned to one of two dose levels of Invega: 6 mg with the option to reduce to 3 mg (n = 108) or 12 mg with the option to reduce to 9 mg (n = 98) once daily. In the other study, 214 subjects received flexible doses of Invega (Paliperidone) (3-12 mg once daily). Both studies included subjects who received this medicine either as monotherapy or as an adjunct to mood stabilizers and/or antidepressants. Adverse events during exposure to study treatment were obtained by general inquiry and recorded by clinical investigators using their own terminology. Consequently, to provide a meaningful estimate of the proportion of individuals experiencing adverse events, events were grouped in standardized categories using MedDRA terminology.
Throughout this section, adverse reactions are reported. Adverse reactions are adverse events that were considered to be reasonably associated with the use of Invega (adverse drug reactions) based on the comprehensive assessment of the available adverse event information. A causal association for Invega (Paliperidone) often cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials - Schizoaffective Disorder in Adults
Monotherapy versus Adjunctive Therapy
The designs of the two placebo-controlled, 6-week, double-blind trials in adult subjects with schizoaffective disorder included the option for subjects to receive antidepressants (except monoamine oxidase inhibitors) and/or mood stabilizers (lithium, valproate, or lamotrigine). In the subject population evaluated for safety, 230 (55%) subjects received Invega (Paliperidone) as monotherapy and 190 (45%) subjects received this drug as an adjunct to mood stabilizers and/or antidepressants. When comparing these 2 subpopulations, only nausea occurred at a greater frequency (>= 3% difference) in subjects receiving Paliperidone (Invega) as monotherapy.
Discontinuations Due to Adverse Reactions
The percentages of subjects who discontinued due to adverse reactions in the three schizophrenia placebo-controlled, 6-week, fixed-dose studies in adults were 3% and 1% in Invega- and placebo-treated subjects, respectively. The most common reasons for discontinuation were nervous system disorders (2% and 0% in Invega- and placebo-treated subjects, respectively).
Among the adverse reactions in the 6-week, fixed-dose, placebo-controlled study in adolescents with schizophrenia, only dystonia led to discontinuation ( < 1% of Invega-treated subjects).
Schizoaffective Disorder Trials
The percentages of subjects who discontinued due to adverse reactions in the two schizoaffective disorder placebo-controlled 6-week studies in adults were 1% and < 1% in Invega- and placebo-treated subjects, respectively. The most common reasons for discontinuation were gastrointestinal disorders (1% and 0% in Invega- and placebo-treated subjects, respectively).
Dose-Related Adverse Reactions
Based on the pooled data from the three placebo-controlled, 6-week, fixed-dose studies in adult subjects with schizophrenia, among the adverse reactions that occurred with a greater than 2% incidence in the subjects treated with Invega (Paliperidone), the incidences of the following adverse reactions increased with dose: somnolence, orthostatic hypotension, akathisia, dystonia, extrapyramidal disorder, hypertonia, parkinsonism, and salivary hypersecretion. For most of these, the increased incidence was seen primarily at the 12 mg dose, and, in some cases, the 9 mg dose.
In the 6-week, fixed-dose, placebo-controlled study in adolescents with schizophrenia, among the adverse reactions that occurred with > 2% incidence in the subjects treated with Paliperidone (Invega), the incidences of the following adverse reactions increased with dose: tachycardia, akathisia, extrapyramidal symptoms, somnolence, and headache.
Schizoaffective Disorder Trials
In a placebo-controlled, 6-week, high- and low-dose study in adult subjects with schizoaffective disorder, akathisia, dystonia, dysarthria, myalgia, nasopharyngitis, rhinitis, cough, and pharyngolaryngeal pain occurred more frequently (i.e., a difference of at least 2%) in subjects who received higher doses of Invega compared with subjects who received lower doses.
An examination of population subgroups in the three placebo-controlled, 6-week, fixed-dose studies in adult subjects with schizophrenia and in the two placebo-controlled, 6-week studies in adult subjects with schizoaffective disorder did not reveal any evidence of clinically relevant differences in safety on the basis of gender or race alone; there was also no difference on the basis of age.
Extrapyramidal Symptoms (EPS)
Pooled data from the three placebo-controlled, 6-week, fixed-dose studies in adult subjects with schizophrenia provided information regarding treatment-emergent EPS. Several methods were used to measure EPS:
the Simpson-Angus global score (mean change from baseline) which broadly evaluates Parkinsonism,
the Barnes Akathisia Rating Scale global clinical rating score (mean change from baseline) which evaluates akathisia,
use of anticholinergic medications to treat emergent EPS,
incidence of spontaneous reports of EPS.
For the Simpson-Angus Scale, spontaneous EPS reports and use of anticholinergic medications, there was a dose-related increase observed for the 9 mg and 12 mg doses. There was no difference observed between placebo and Invega (Paliperidone) 3 mg and 6 mg doses for any of these EPS measures.
Compared to data from the studies in adults subjects with schizophrenia, pooled data from the two placebo-controlled 6-week studies in adult subjects with schizoaffective disorder showed similar types and frequencies of EPS as measured by rating scales, anticholinergic medication use, and spontaneous reports of EPS-related adverse events. For subjects with schizoaffective disorder, there was no dose-related increase in EPS observed for parkinsonism with the Simpson-Angus scale or akathisia with the Barnes Akathisia Rating Scale. There was a dose-related increase observed with spontaneous EPS reports of hyperkinesia and dystonia and in the use of anticholinergic medications.
The incidences of EPS-related adverse events in the adolescent schizophrenia studies showed a similar dose-related pattern to those in the adult studies. There were notably higher incidences of dystonia, hyperkinesia, tremor, and parkinsonism in the adolescent population as compared to the adult studies.
Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.
Laboratory Test Abnormalities
In the pooled data from the three placebo-controlled, 6-week, fixed-dose studies in adult subjects with schizophrenia and from the two placebo-controlled, 6-week studies in adult subjects with schizoaffective disorder, between-group comparisons revealed no medically important differences between Paliperidone (Invega) and placebo in the proportions of subjects experiencing potentially clinically significant changes in routine serum chemistry, hematology, or urinalysis parameters. Similarly, there were no differences between Invega (Paliperidone) and placebo in the incidence of discontinuations due to changes in hematology, urinalysis, or serum chemistry, including mean changes from baseline in fasting glucose, insulin, c-peptide, triglyceride, HDL, LDL, and total cholesterol measurements. However, Invega was associated with increases in serum prolactin.
Other Adverse Reactions Observed During Premarketing Evaluation of Invega
The following additional adverse reactions occurred in < 2% of Invega-treated subjects in the above schizophrenia and schizoaffective disorder clinical trial datasets. The following also includes additional adverse reactions reported at any frequency by Invega-treated subjects who participated in other clinical studies.
Eye disorders: eye movement disorder
Cardiac disorders: bradycardia, palpitations
Gastrointestinal disorders: flatulence
Immune system disorders: anaphylactic reaction
General disorders: edema
Infections and infestations: urinary tract infection
Musculoskeletal and connective tissue disorders: arthralgia, pain in extremity
Investigations: alanine aminotransferase increased, aspartate aminotransferase increased
Nervous system disorders: opisthotonus
Reproductive system and breast disorders: menstruation irregular, breast discomfort, retrograde ejaculation
Psychiatric disorders: insomnia, agitation, nightmare
Respiratory, thoracic and mediastinal disorders: nasal congestion
Vascular disorders: hypertension
Skin and subcutaneous tissue disorders: pruritus, rash
The safety of Paliperidone (Invega) was also evaluated in a long-term trial designed to assess the maintenance of effect with this medicine in adults with schizophrenia. In general, adverse reaction types, frequencies, and severities during the initial 14-week open-label phase of this study were comparable to those observed in the 6-week, placebo-controlled, fixed-dose studies. Adverse reactions reported during the long-term double-blind phase of this study were similar in type and severity to those observed in the initial 14-week open-label phase.
The following adverse reactions have been identified during postapproval use of Invega (Paliperidone); because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency: priapism, angioedema, swollen tongue, urinary incontinence, tardive dyskinesia, urinary retention.
Adverse Reactions Reported with Risperidone
Paliperidone is the major active metabolite of risperidone. Adverse reactions reported with risperidone can be found in the "adverse reactions" section of the risperidone package insert.
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