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INVEGA TRINZA is a brand name for Paliperidone, supplied as a suspension (extended-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: INVEGA TRINZA® (paliperidone palmitate prolonged-release injectable suspension), a 3-month injection, is indicated for the treatment of schizophrenia in adult patients. Invega Trinza is to be used only after Invega Sustenna (1-month paliperidone palmitate prolonged-release injectable suspension) has been established…
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 09/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ....................................................................................
2 TABLE OF CONTENTS .......................................................................................................... 2 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 .................................................. 4 Administration .....................................................................................................
5 Missed Dose ..................................................................................................... 17 5 OVERDOSAGE .........................................................................................................
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). , blurred vision). Patients should be cautioned about performing activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that paliperidone therapy does not adversely affect them.
Endocrine and Metabolism Dyslipidemia Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics. Hyperglycemia and Diabetes Mellitus Hyperglycemia, diabetes mellitus, and exacerbation of pre-existing diabetes, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, have been reported in patients treated with all atypical antipsychotics.
These cases were, for the most part, seen in post-marketing clinical use and epidemiologic studies, and not in clinical trials. Diabetic ketoacidosis (DKA) has occurred in patients treated with antipsychotics with no reported history of hyperglycemia.
Appropriate clinical monitoring of patients treated with antipsychotics is advisable in accordance with utilized antipsychotic guidelines. docx EDMS-RIM-855802 Page 23 of 72 Hyperglycemia and diabetes have been reported in trial subjects treated with Invega Trinza.
Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population.
Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood. However, epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with the atypical antipsychotics.
Precise risk estimates for hyperglycemia- related adverse events in patients treated with atypical antipsychotics are not available. Any patient treated with atypical antipsychotics, including Invega Trinza should be monitored for symptoms of hyperglycemia and diabetes mellitus including polydipsia, polyuria, polyphagia, and weakness.
5 Post-Market Adverse Reactions). For a complete listing of ingredients, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Increased Mortality in Elderly Patients with Dementia Elderly patients with dementia treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo.
6-fold increase in the death rate in the drug-treated patients. 4 Geriatrics, Use in Geriatric Patients with Dementia). Invega Trinza is not indicated for the treatment of elderly patients with dementia. docx EDMS-RIM-855802 Page 5 of 72 4 DOSAGE AND ADMINISTRATION Invega Trinza is only to be administered by intramuscular injection in the gluteal or deltoid muscle by a Healthcare Professional.
4 Administration). 1 Dosing Considerations Hypersensitivity Very rare cases of severe hypersensitivity after injection with 1-month injectable paliperidone have been reported during post-marketing experience in patients who have previously tolerated oral paliperidone or oral risperidone.
Care should be taken to avoid exposure to those that are suspected to be hypersensitive or have shown hypersensitivity reactions to any of the excipients (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). Concomitant use with risperidone, oral paliperidone, or other antipsychotics There are no systematically collected safety data to specifically address concomitant use of Invega Trinza with risperidone, oral paliperidone, or other antipsychotics.
Since paliperidone is the major active metabolite of risperidone, caution should be exercised when Invega Trinza is co-administered with risperidone or oral paliperidone. Endocrine and metabolic effects Hyperglycemia and diabetes mellitus have been reported with atypical antipsychotic drugs, including Invega Trinza.
• Blood glucose should be tested at the beginning of treatment and periodically thereafter in patients with risk factors for diabetes mellitus. • Patients with a diagnosis of diabetes mellitus should be periodically monitored for worsening of glucose control.
5 Post-Market Adverse Reactions). For a complete listing of ingredients, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.
, obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control.
Hyperprolactinemia As with other atypical antipsychotics that antagonize dopamine D2 receptors, paliperidone elevates prolactin levels and the elevation persists during chronic administration. Paliperidone has a prolactin-elevating effect similar to that seen with risperidone.
Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro, a factor of potential importance if the prescription of these drugs is considered in a patient with previously detected breast cancer.
Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin- elevating compounds, the clinical significance of elevated serum prolactin levels is unknown for most patients. Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone mineral density in both female and male subjects.
As is common with dopamine D2 antagonists, prolonged administration of risperidone in rodent carcinogenicity studies resulted in an increase in the incidence of pituitary gland, mammary gland, and endocrine pancreas hyperplasia and/or tumours (see 16 NON-CLINICAL TOXICOLOGY).
However, neither clinical studies nor epidemiologic studies conducted to date have shown an association between chronic administration of this class of drugs and tumorigenesis in humans; the available evidence is considered too limited to be conclusive at this time.
The carcinogenic potential of paliperidone, an active metabolite of risperidone, was assessed based on studies with risperidone conducted in mice and rats. docx EDMS-RIM-855802 Page 24 of 72 studies and were not serious; most were mild or moderate in severity and mostly did not result in discontinuation of study treatment.
A higher proportion of females experienced potentially prolactin-related adverse reactions compared to males. Weight Gain Weight gain has been observed with atypical antipsychotic use. 2 Clinical Trial Adverse Reactions, Weight). Gastrointestinal Antiemetic Effect An antiemetic effect was observed in preclinical studies with paliperidone.
This effect, if it occurs in humans, may mask the signs and symptoms of overdosage with certain drugs or of conditions such as intestinal obstruction, Reye’s syndrome, and brain tumour. Genitourinary Priapism Drugs with alpha-adrenergic blocking effects have been reported to induce priapism.
5 Post-Market Adverse Reactions). This adverse reaction, as with other psychotropic drugs, did not appear to be dose-dependent and did not […]
See 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism. Hematologic effects Complete blood count (CBC) should be periodically monitored in patients with a history of a clinically significant low white blood cell count or drug-induced leukopenia/neutropenia.
Discontinuation of Invega Trinza should be considered at the first sign of a clinically significant decline in white blood cell count (WBC) in the absence of other causative factors. See 7 WARNINGS AND PRECAUTIONS, Hematologic. 2 Recommended Dose and Dosage Adjustment Adult Invega Trinza is to be used only after Invega Sustenna (1-month paliperidone palmitate prolonged-release injectable suspension) has been established as adequate treatment for at least four months.
In order to establish a consistent maintenance dose, it is recommended that the last two doses of Invega Sustenna be the same dosage strength before starting Invega Trinza. 5-fold multiplier as shown in Table 1. Invega Trinza may be administered up to 7 days before or after the monthly time point of the next scheduled paliperidone palmitate 1-month dose.
5 as a multiplier If the last dose of Invega Sustenna is: Initiate Invega Trinza at the following dose: 50 mg 175 mg 75 mg 263 mg 100 mg 350 mg 150 mg 525 mg Following the initial Invega Trinza dose, Invega Trinza should be administered every 3 months.
If needed, dose adjustment can be made every 3 months in increments within the range of 175 mg to 525 mg based on individual patient tolerability and/or efficacy. Due to the long- acting nature of Invega Trinza, the patient’s response to an adjusted dose may not be apparent for several months (see 10 CLINICAL PHARMACOLOGY).
4 Administration. 3 Pharmacokinetics, Special Populations and Conditions). 5 to 1 ratio (see Table 1). The maximum recommended dose of Invega Trinza in patients with mild renal impairment is 350 mg. 3 Pharmacokinetics, Special Populations and Conditions).
Patients with Hepatic Impairment Invega Trinza has not been studied in patients with hepatic impairment. Based on a study with oral paliperidone, no dose adjustment is required in patients with mild or moderate hepatic impairment. 3 Pharmacokinetics, Special Populations and Conditions).
g,, carbamazepine), the dose of Invega Trinza should be re-evaluated and increased if necessary. […]