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OKEDI is a brand name for Risperidone, supplied as a kit. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: OKEDI (risperidone for extended-release injectable suspension) is indicated for the treatment of schizophrenia in adults. The efficacy of OKEDI was demonstrated in a 12-week, placebo-controlled trial in patients with schizophrenia experiencing an acute exacerbation. The effectiveness of OKEDI in longer-term use, that…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • For patients who have never taken risperidone, establish tolerability with oral risperidone prior to initiating treatment with OKEDI. • OKEDI should not be supplemented with oral risperidone. • Do not administer a loading dose.
4 Administration). 4 Administration). • Caution should be exercised in patients prone to hypotension. Consider using lower starting doses (See 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Orthostatic Hypotension and Syncope). 2 Recommended Dose and Dosage Adjustment Recommended Dose • Each injection should only be administered by a healthcare professional using the appropriate enclosed needle.
• OKEDI is to be administered as intramuscular deltoid or gluteal injection only. Do not administer by any other route. • For patients who have never taken risperidone, it is recommended to establish the tolerability with oral risperidone prior to initiating with OKEDI.
• Administer OKEDI at a dose of 75 mg or 100 mg once every 4 weeks by intramuscular injection. Patients should be reassessed periodically for treatment response. To avoid missing the 4-week dose interval, patients may be given the injection up to 3 days before the 4-week time-point.
The next dose should remain the same as planned (even if the dose was administered up to 3 days in advance). 3 Pharmacokinetics). • Dose adjustment cannot be made during the 4-week period immediately after a dose administration. Do not administer more than one dose (75 mg or 100 mg total) per 4 weeks.
, risperidone plus its active metabolite 9- hydroxyrisperidone) at steady-state are as follows: • OKEDI injection 75 mg once every 4 weeks is similar to oral risperidone dose of 3 mg/day. • OKEDI injection 100 mg once every 4 weeks is similar to oral risperidone dose of 4 mg/day.
• Patients who are stable on oral risperidone doses lower than 3 mg/day or higher than 4 mg/day may not be candidates for OKEDI. 1 Pediatrics). Geriatrics Clinical studies of OKEDI in the treatment of schizophrenia did not include patients older than 65 years (see 14 CLINICAL TRIALS).
In general, dose selection for an elderly patient should be cautious. Starting Product Monograph OKEDI risperidone for extended-release injectable suspension Page 6 of 63 dose in this population should be OKEDI 75 mg. 4 Geriatrics). Patients with Renal or Hepatic Impairment OKEDI has not been systematically studied in patients with renal or hepatic impairment, and therefore it should be used with caution in these special populations.
1 Adverse Reaction Overview The same adverse events described for other risperidone or paliperidone containing products should be considered in treatment with OKEDI. The very commonly reported adverse events (AEs) (reported by ≥ 10%) are blood prolactin increase, hyperprolactinemia, akathisia, headache, somnolence, weight increased, injection site pain, and dizziness.
In addition, the frequency of reported injection site reactions was similar across treatment groups with both OKEDI and placebo; the common (≥ 5%) of which was injection site pain. The systemic safety profile for OKEDI, was consistent with the known safety profile of oral risperidone.
4%) in the placebo-controlled, randomized, double-blind, 12-week study. 5%). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, 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 may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The safety of OKEDI was evaluated in a total of 549 adult subjects with schizophrenia who received at least 1 dose of OKEDI of either the recommended dose of 75 mg or 100 mg, during the clinical development program.
At total of 147 subjects with schizophrenia received placebo. From the 549 subjects with schizophrenia who received OKEDI, 163 were in clinical studies of the development program and 386 were included in the placebo-controlled, randomized, double-blind, 12-week study and/or its 1-year open-label extension (OLE).
From this study, 290 received OKEDI during the DB + OLE phases, 55 subjects were subjects from the placebo arm of the DB phase continue in the OLE phase, and 41 were de novo subjects in the OLE phase. 1%) who received 16 doses of OKEDI.
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 OKEDI is not approved for the treatment of 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. , pneumonia) in nature. (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Geriatrics).
1 Dosing Considerations • For patients who have never taken risperidone, establish tolerability with oral risperidone prior to initiating treatment with OKEDI. • OKEDI should not be supplemented with oral risperidone. • Do not administer a loading dose.
4 Administration). 4 Administration). • Caution should be exercised in patients prone to hypotension. Consider using lower starting doses (See 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Orthostatic Hypotension and Syncope). 2 Recommended Dose and Dosage Adjustment Recommended Dose • Each injection should only be administered by a healthcare professional using the appropriate enclosed needle.
• OKEDI is to be administered as intramuscular deltoid or gluteal injection only. Do not administer by any other route. • For patients who have never taken risperidone, it is recommended to establish the tolerability with oral risperidone prior to initiating with OKEDI.
• Administer OKEDI at a dose of 75 mg or 100 mg once every 4 weeks by intramuscular injection. Patients should be reassessed periodically for treatment response. To avoid missing the 4-week dose interval, patients may be given the injection up to 3 days before the 4-week time-point.
The next dose should remain the same as planned (even if the dose was administered up to 3 days in advance). 3 Pharmacokinetics). • Dose adjustment cannot be made during the 4-week period immediately after a dose administration. Do not administer more than one dose (75 mg or 100 mg total) per 4 weeks.
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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Based on oral risperidone, patients with renal impairment have less ability to eliminate the active antipsychotic fraction than adults with normal renal function (see 7 WARNINGS AND PRECAUTIONS, General, Renal). Patients with impaired hepatic function have increases in plasma concentration of the free fraction of risperidone and this may result in an enhanced effect associated with a safety risk namely drowsiness, sedation, tachycardia, hypotension and extrapyramidal symptoms (7 WARNINGS AND PRECAUTIONS, General, Hepatic/Biliary/Pancreatic).
OKEDI should be used with caution in these groups of patients. A careful titration up to at least 3 mg daily with oral risperidone (halving starting doses and slowing titration) before initiating treatment with OKEDI at a dose of 75 mg is recommended, if considered appropriate.
Dosage Recommendations for Concomitant Use with Strong CYP2D6 Inhibitors and Strong CYP3A4 Inducers • Co-administration with Strong CYP2D6 Inhibitors When considering initiation of treatment with CYP2D6 inhibitors such as fluoxetine or paroxetine, patients treated with OKEDI 100 mg should be treated with the lowest dose (75 mg) of OKEDI for 2 to 4 weeks before the planned start of fluoxetine or paroxetine therapy with a CYP2D6 inhibitor, to adjust for the expected increase in plasma concentrations of risperidone (See 9 DRUG INTERACTIONS).
• Co-administration with Strong CYP3A4 Inducers At the initiation of therapy with CYP3A4 inducers, such as carbamazepine or other known hepatic enzyme inducers, patients should be closely monitored during the first 4 to 8 weeks. On discontinuation of carbamazepine or other strong CYP3A4 hepatic enzyme inducers, the dosage of OKEDI should be re-evaluated and, if necessary, decreased to adjust for the expected increase in plasma concentration of risperidone (See 9 DRUG INTERACTIONS).
4 Administration INSTRUCTIONS FOR USE OKEDI Risperidone for extended-release injectable suspension 75 mg, single use For intramuscular injection only after reconstitution Do not administer by any other route Product Monograph OKEDI risperidone for extended-release injectable suspension Page 7 of 63 Important Information • To be administered by a healthcare professional only.
• To be administered immediately after reconstitution. • To be administered intramuscularly only, in gluteal or deltoid muscle, do not inject by any other route. • Two administration safety needles are […]
Treatment Emergent Adverse Events (TEAEs) with an incidence of 1% or more and greater than placebo are shown in Table 3. Table 3 –Treatment Emergent Adverse Events in 1% or More of OKEDI-Treated Subjects (and Greater than Placebo) in a 12-Week Double-Blind, Placebo-Controlled, Fixed-Dose Schizophrenia Trial.
4) Selected Adverse Events Changes in Body Weight: Data from a 12-week double-blind (DB), placebo-controlled trial indicate a dose-dependant increase in the weight gain ≥ 7% increase from baseline to postdose assessments in OKEDI 75 mg and 100 mg groups compared to placebo.
Data from the 12-week DB, placebo-controlled study with OKEDI in adults subjects with schizophrenia are presented in Table 4. Table 4– Change in Body Weight from Baseline to End of Study and ≥ 7% increase from baseline in a 12-week double-blind, placebo-controlled study in adult participants with schizophrenia OKEDI 75 mg OKEDI 100 mg Placebo Weight * Mean Change from Baseline to End of Study, kg […]
, risperidone plus its active metabolite 9- hydroxyrisperidone) at steady-state are as follows: • OKEDI injection 75 mg once every 4 weeks is similar to oral risperidone dose of 3 mg/day. • OKEDI injection 100 mg once every 4 weeks is similar to oral risperidone dose of 4 mg/day.
• Patients who are stable on oral risperidone doses lower than 3 mg/day or higher than 4 mg/day may not be candidates for OKEDI. 1 Pediatrics). Geriatrics Clinical studies of OKEDI in the treatment of schizophrenia did not include patients older than 65 years (see 14 CLINICAL TRIALS).
In general, dose selection for an elderly patient should be cautious. Starting Product Monograph OKEDI risperidone for extended-release injectable suspension Page 6 of 63 dose in this population should be OKEDI 75 mg. 4 Geriatrics). Patients with Renal or Hepatic Impairment OKEDI has not been systematically studied in patients with renal or hepatic impairment, and therefore it should be used with caution in these special populations.
Based on oral risperidone, patients with renal impairment have less ability to eliminate the active antipsychotic fraction than adults with normal renal function (see 7 WARNINGS AND PRECAUTIONS, General, Renal). Patients with impaired hepatic function have increases in plasma concentration of the free fraction of risperidone and this may result in an enhanced effect associated with a safety risk namely drowsiness, sedation, tachycardia, hypotension and extrapyramidal symptoms (7 WARNINGS AND PRECAUTIONS, General, Hepatic/Biliary/Pancreatic).
OKEDI should be used with caution in these groups of patients. A careful titration up to at least 3 mg daily with oral risperidone (halving starting doses and slowing titration) before initiating treatment with OKEDI at a dose of 75 mg is recommended, if considered appropriate.
Dosage Recommendations for Concomitant Use with Strong CYP2D6 Inhibitors and Strong CYP3A4 Inducers • Co-administration with Strong CYP2D6 Inhibitors When considering initiation of treatment with CYP2D6 inhibitors such as fluoxetine or paroxetine, patients treated with OKEDI 100 mg should be treated with the lowest dose (75 mg) of OKEDI for 2 to 4 weeks before the planned start of fluoxetine or paroxetine therapy with a CYP2D6 inhibitor, to adjust for the expected increase in plasma concentrations of risperidone (See 9 DRUG INTERACTIONS).
• Co-administration […]