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INVEGA SUSTENNA 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: Adults INVEGA SUSTENNA® (paliperidone palmitate prolonged-release injectable suspension) is indicated for: • the treatment of schizophrenia. In controlled clinical trials, Invega Sustenna was found to improve the symptoms of schizophrenia, including positive and negative symptoms. • maintenance treatment of…
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 ................................................... 5 4 DOSAGE AND ADMINISTRATION .............................................................................
1 Dosing Considerations ....................................................................................... 2 Recommended Dose and Dosage Adjustment .................................................. 4 Administration .....................................................................................................
5 Missed Dose ..................................................................................................... 13 5 OVERDOSAGE .........................................................................................................
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). , blurred vision). Therefore, patients should be cautioned about performing activities requiring mental alertness and advised not to drive a motor vehicle or operate hazardous machinery 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. In clinical trials, there have been reports of hyperglycemia or diabetes (< 3%) in subjects treated with Invega Sustenna.
docx EDMS-RIM-855755 Page 19 of 68 diabetes mellitus in patients with schizophrenia or schizoaffective disorder 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.
5 Post-Market Adverse Reactions). For a complete listing of ingredients, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. docx EDMS-RIM-855755 Page 5 of 68 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 Sustenna is not indicated for the treatment of elderly patients with dementia. 4 DOSAGE AND ADMINISTRATION Invega Sustenna is only to be administered by intramuscular injection in the gluteal or deltoid muscle by a Healthcare Professional.
4 Administration). 1 Dosing Considerations For patients who have never taken oral paliperidone or oral/injectable risperidone, tolerability with oral paliperidone or oral risperidone should be established prior to initiating treatment with Invega Sustenna.
Hypersensitivity Very rare cases of severe hypersensitivity after injection with Invega Sustenna 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 Sustenna with risperidone, oral paliperidone, or other antipsychotics.
Since paliperidone is the major active metabolite of risperidone, caution should be exercised when Invega Sustenna 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 Sustenna.
5 Post-Market Adverse Reactions). For a complete listing of ingredients, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. docx EDMS-RIM-855755 Page 5 of 68
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Any patient treated with atypical antipsychotics, including Invega Sustenna should be monitored for symptoms of hyperglycemia and diabetes mellitus including polydipsia, polyuria, polyphagia, and weakness. 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. In the four fixed-dose, double-blind, placebo-controlled studies with Invega Sustenna (25 mg– 150 mg), the proportion of subjects who experienced potentially prolactin-related adverse events was similar for the placebo (1%) and Invega Sustenna (1–2%) groups.
Weight Gain Weight gain has been observed with atypical antipsychotic use. 2 Clinical Trial Adverse Reactions, Weight Gain). docx EDMS-RIM-855755 Page 20 of 68 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 correlate with the duration of treatment. Although no cases of priapism have been reported […]
• 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.
See 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism. docx EDMS-RIM-855755 Page 6 of 68 Hematologic effects Complete blood count (CBC) should be tested frequently during first few months of therapy in patients with a history of a clinically significant low white blood cell count or drug-induced leukopenia/neutropenia.
Discontinuation of Invega Sustenna 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 Schizophrenia Recommended initiation regimen of Invega Sustenna is with a dose of 150 mg on treatment day 1 and 100 mg on day 8 (one week later), both administered in the deltoid muscle in order to attain therapeutic concentrations rapidly (see 10 CLINICAL PHARMACOLOGY).
Recommendations for switching from other antipsychotics are provided in the subsection Switching Antipsychotic Agents to follow. The recommended subsequent monthly maintenance dose is 75 mg; this dose can be higher or lower within the recommended range of 25╪ to 150 mg based on individual patient tolerability and/or efficacy.
Starting one month after the second initiation regimen dose, monthly maintenance doses can be administered in either the deltoid or gluteal muscle. ǂ Not currently available in Canada Schizoaffective Disorder Recommended initiation regimen of Invega Sustenna is with a dose of 150 mg on treatment day 1 and 100 mg on day 8 (one week later), both administered in the deltoid muscle in order to attain therapeutic concentrations rapidly (see 10 CLINICAL PHARMACOLOGY).
Recommendations for switching from other antipsychotics are provided in the subsection Switching Antipsychotic Agents to follow. The recommended monthly maintenance dose is within the range of 50 to 150 mg adjusted based on tolerability and/or efficacy.
Following the second initiation dose, monthly maintenance doses can be administered in either the deltoid or gluteal muscle. Adjustment of the maintenance dose may be made monthly. When making dose adjustments, the prolonged-release characteristics of Invega Sustenna should be considered (see 10 CLINICAL PHARMACOLOGY), as the full effect of the dose adjustment may not be evident for several months.
3 Pharmacokinetics, Special Populations and Conditions). For patients with mild renal impairment (creatinine clearance ≥ 50 to < 80 mL/min), recommended initiation of Invega Sustenna is with a dose of 100 mg on treatment day 1 and 75 mg one week later, both administered in the deltoid muscle.
docx EDMS-RIM-855755 Page 7 of 68 the deltoid or gluteal muscle, adjusted within the range of 25╪ to 100 mg based on individual patient tolerability and/or efficacy. ǂ Not currently available in Canada Invega Sustenna is not recommended in patients with moderate or severe renal […]