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INVEGA is a brand name for Paliperidone, supplied as a tablet (extended-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: INVEGA® (paliperidone) is indicated for the treatment of schizophrenia and related psychotic disorders. In controlled clinical trials, INVEGA® was found to improve the symptoms of schizophrenia, including positive and negative symptoms. 1.1 Pediatrics Pediatrics (< 18 years of age): Based on the data submitted and…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations There are no systematically collected safety data to specifically address concomitant use of INVEGA® with risperidone, paliperidone palmitate or other antipsychotics. Since paliperidone is the major active metabolite of risperidone, caution should be exercised when INVEGA® is co- administered with risperidone or paliperidone palmitate.
2 Recommended Dose and Dosage Adjustment Adult The recommended starting and target dose of INVEGA® is 6 mg once daily. No initial dose titration is required. However, in some cases a lower dose of 3 mg/day may be sufficient. In clinical trials a dose range of 3 to 12 mg/day was studied and while efficacy was observed across all doses, there was a dose-related increase in adverse effects (see ADVERSE REACTIONS and CLINICAL TRIALS).
Dose adjustments should be made after clinical reassessment and generally should occur at intervals of more than 5 days. When dose adjustments are indicated, small increments/decrements of 3 mg/day are recommended, up to a maximum of 12 mg/day.
Dosage Adjustments for Special Populations Patients with Hepatic Impairment No dose adjustment is required in patients with mild to moderate hepatic impairment. INVEGA® has not been studied in patients with severe hepatic impairment.
Patients with Renal Impairment For patients with mild renal impairment (creatinine clearance = 50 to < 80 mL/min), the maximum recommended initial dose is 3 mg once daily. The dose may be increased to a maxiumum of 6 mg once daily based on clinical response and tolerability.
For patients with moderate to severe renal impairment (creatinine clearance = 10 to < 50 mL/min), the recommended initial dose of INVEGA® is 3 mg every other day, which may then be increased to 3 mg once daily after clinical reassessment.
As INVEGA® has not been studied in patients with creatinine clearance < 10 mL/min, use is not recommended in such patients. Pediatrics Safety and effectiveness of INVEGA® in patients < 18 years of age have not been established and its use is not recommended.
Elderly Dosing recommendations for elderly patients with normal renal function (≥ 80 mL/min) are the same as for adults with normal renal function. However, because elderly patients may have diminished renal function, dose adjustments may be required according to their renal function status (see Patients with Renal Impairment above).
1 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. 0 Page 17 of 49 Short-Term, Placebo-Controlled Studies Five studies have been conducted in adult patients with schizophrenia and related psychotic disorders.
The information presented in this section was derived from two sets of pooled data: 1. Three placebo-controlled, 6-week, fixed-dose studies conducted in non-elderly (mean age 38 years) patients with schizophrenia. The doses studied among these three trials included 3, 6, 9, 12, and 15 mg/day (see CLINICAL TRIALS).
2. Two placebo-controlled, 6-week studies, including one two-dose, parallel-group study and one flexible-dose study, in patients with related psychotic disorders (DSM-IV diagnosis of schizoaffective disorder). In one trial 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® (3–12 mg once daily) (see CLINICAL TRIALS). Body systems and adverse event/adverse reaction terms are based on the MedDRA dictionary. Adverse Events Associated with Discontinuation of Treatment In the three fixed-dose short-term schizophrenia studies, overall, there was no difference in the incidence of discontinuation due to adverse events between patients who received INVEGA® (5%) and placebo-treated patients (5%).
The types of adverse events that led to discontinuation were similar between patients treated with INVEGA® and placebo-treated patients, except for Nervous System Disorders (2% and 0%, respectively) and Gastrointestinal Disorders (1% and 0%, respectively) which were of greater incidence among patients treated with INVEGA® than placebo- treated patients, and Psychiatric Disorders which were of greater incidence among placebo-treated patients than patients treated with INVEGA® (3% and 1%, respectively).
, Skin 12/2020 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..................................................... 4 1 INDICATIONS .......................................................................................................
1 Pediatrics ..................................................................................................... 2 Geriatrics ...................................................................................................... 4 2 CONTRAINDICATIONS .......................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX............................................. 4 4 DOSAGE AND ADMINISTRATION ...................................................................... 1 Dosing Considerations .................................................................................
2 Recommended Dose and Dosage Adjustment ............................................ 5 5 OVERDOSAGE .................................................................................................... 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ..............
6 7 WARNINGS AND PRECAUTIONS ...................................................................... 1 Special Populations .................................................................................... 16 8 ADVERSE REACTIONS .....................................................................................
1 Clinical Trial Adverse Reactions................................................................. 2 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ................................................................................................
3 Clinical Trial Adverse Reactions (Pediatrics).............................................. 4 Post-Market Adverse Reactions ................................................................. 26 9 DRUG INTERACTIONS ......................................................................................
INVEGA® is contraindicated in patients who are hypersensitive to paliperidone, risperidone, or to any ingredient in the formulation or component of the container. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been observed in patients treated with risperidone and paliperidone or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Paliperidone in Canada.
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0 Page 6 of 49 No dose adjustment for INVEGA® is recommended based on gender, race, or smoking status. Administration INVEGA® should be administered orally once daily, preferably in the morning, without regard to meals. Clinical trials establishing the safety and efficacy of INVEGA® were carried out in patients without regard to food intake.
INVEGA® must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed. The medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate. The tablet shell, along with insoluble core components, is eliminated from the body; patients should not be concerned if they occasionally notice something that looks like a tablet in their stool.
Missed dose If a patient misses their daily dose, they are to take their regular dose the following day and are not to double the dose to make up for a forgotten dose.
The pattern of adverse events observed in the schizoaffective trials were similar to those observed in schizophrenia trials. 1 enumerates all treatment-emergent adverse events, regardless of causality, reported at an incidence of ≥ 1% of adult patients treated with INVEGA® in the three fixed-dose short-term schizophrenia studies, and for which the incidence in patients treated with INVEGA® was greater than the incidence in patients treated with placebo.
The most common adverse events (incidence of ≥ 5% and paliperidone incidence at least twice the rate of placebo) in subjects treated with INVEGA® included: tachycardia (7%; placebo 3%), and extrapyramidal disorder (5%; placebo 2%).
1: Treatment-Emergent Adverse Events Reported by ≥ 1% of INVEGA® – treated Adult Subjects with Schizophrenia in Three Short-term, Fixed Dose Placebo-Controlled Clinical Trialsa. 1: Treatment-Emergent Adverse Events Reported by ≥ 1% of INVEGA® – treated Adult Subjects with Schizophrenia in Three Short-term, Fixed Dose Placebo-Controlled Clinical Trialsa.
(Safety Analysis Set) INVEGA® Placebo 3 mg 6 mg 9 mg 12 mg Body System or Organ Class (N=355) (N=127) (N=235) (N=246) (N=242) Dictionary-derived Term % % % % % Investigations Alanine aminotransferase increased 1 1 2 1 1 Blood creatine phosphokinase increased 1 1 2 0 <1 Blood insulin increased 1 2 1 1 <1 Blood pressure increased 1 2 <1 <1 1 Blood triglycerides increased <1 2 <1 0 0 Electrocardiogram QT corrected interval prolonged 3 3 4 3 5 Electrocardiogram T wave abnormal 1 2 1 2 1 Electrocardiogram T wave inversion 1 0 <1 1 1 Electrocardiogram abnormal 0 0 0 2 1 Heart rate increased 1 3 1 <1 1 Insulin C-peptide increased 1 2 1 1 0 Weight decreased 1 2 0 0 0 Weight increased 1 1 0 2 2 Metabolism and nutrition disorders Decreased appetite 0 2 <1 <1 1 Increased appetite <1 2 0 1 1 Musculoskeletal and connective tissue disorders Arthralgia 1 0 2 1 0 Back pain 1 1 1 1 2 Muscle rigidity 0 1 0 1 <1 Neck pain <1 0 0 0 1 Pain in extremity 1 0 1 0 2 Shoulder pain 0 1 1 1 1 Nervous system disorders Akathisia 4 4 3 8 10 Dizziness 4 6 5 4 5 Dyskinesia 1 0 <1 <1 2 Dystonia 1 1 1 4 4 Extrapyramidal disorder 2 5 2 7 7 Headache 12 11 12 14 14 Hypertonia 1 2 1 4 3 Parkinsonism 0 0 <1 2 1 Sedation 4 1 5 3 6 Somnolence 3 5 3 7 5 Syncope <1 1 1 1 <1 Tremor 3 3 3 4 3 […]
1 Drug-Drug Interactions ............................................................................... 2 Drug-Food Interactions .............................................................................. 3 Drug-Herb Interactions ...............................................................................
4 Drug-Laboratory Test Interactions .............................................................. 5 Drug-Lifestyle Interactions.......................................................................... 30 10 ACTION AND CLINICAL PHARMACOLOGY ....................................................
1 Mechanism of Action............................................................................... 2 Pharmacodynamics ................................................................................ 3 Pharmacokinetics....................................................................................
31 11 STORAGE, STABILITY AND DISPOSAL .......................................................... 34 12 SPECIAL HANDLING INSTRUCTIONS ............................................................. 34 PART II: SCIENTIFIC INFORMATION ..........................................................................
0 Page 3 of 49 13 PHARMACEUTICAL INFORMATION ................................................................ 35 14 CLINICAL TRIALS ............................................................................................. 35 15 MICROBIOLOGY................................................................................................
37 16 NON-CLINICAL TOXICOLOGY ......................................................................... 37 17 SUPPORTING PRODUCT MONOGRAPHS ...................................................... 38 PATIENT MEDICATION INFORMATION ......................................................................
0 Page 4 of 49 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS INVEGA® (paliperidone) is indicated for the treatment of schizophrenia and related psychotic disorders. In controlled clinical trials, INVEGA® was found to improve the symptoms of schizophrenia, including positive and negative symptoms.
1 Pediatrics Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of INVEGA® in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use and its use is not recommended.
See WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics. 2 Geriatrics Geriatrics (> 65 years of age): Elderly patients with dementia treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo.
INVEGA® is not indicated for the treatment of elderly patients with dementia. See SERIOUS WARNINGS AND PRECAUTIONS BOX and WARNINGS AND PRECAUTIONS, Special Populations, Geriatrics. 2 CONTRAINDICATIONS INVEGA® is contraindicated in patients who are hypersensitive to paliperidone, risperidone, or to any ingredient in the formulation or component of the container.
Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been observed in patients treated with […]