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LONGAVO is a brand name for Risperidone, supplied as a suspension (extended-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , Pediatrics and 7.1.3 Pediatrics). • Geriatrics: Clinical studies of LONGAVO 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 dose should be at the low end of the dosing range (see…
Verbatim from this product's HC label. Tap a section to expand.
3 Pharmacokinetics, Special Populations and Conditions). LONGAVO (risperidone) Page 21 of 60 Immune Hypersensitivity Patients with hypersensitivity to oral risperidone, paliperidone, or to any other ingredient of the formulation or component of the container, should not be treated with LONGAVO (see 2 CONTRAINDICATIONS).
, anaphylaxis, angioedema, anaphylactic shock) in some patients after injection with risperidone. It is unknown how many of these patients previously tolerated oral risperidone or paliperidone. However, anaphylactic-type reactions have occurred after injection with risperidone in patients who have previously tolerated oral risperidone or oral paliperidone.
Symptoms of anaphylaxis include skin rash, hives, peripheral edema, swollen eye, tongue and face, hyperhidrosis, dyspnea, and hypotension. Discontinue exposure to LONGAVO if such symptoms occur. Caution should also be exercised in patients who have had serious allergic reactions to other medications.
Prior to initiating treatment with LONGAVO, tolerability with oral risperidone should be established (see 4 DOSAGE AND ADMINISTRATION). For a complete listing of ingredients, see
, Post- Market Adverse Reactions). 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 LONGAVO, should be monitored for symptoms of hyperglycemia and diabetes mellitus including polydipsia, polyuria, polyphagia, and weakness.
Patients who develop symptoms of hyperglycemia and diabetes mellitus during treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment with LONGAVO and periodically during treatment.
In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of antidiabetic treatment despite discontinuation of risperidone. , obesity, family history of diabetes) who are starting treatment with atypical antipsychotics including LONGAVO 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 LONGAVO should be monitored regularly for worsening of glucose control. Hyperprolactinemia As with other drugs that antagonize dopamine D2 receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration.
, Hypersensitivity); or to any ingredient in the formulation including any non-medicinal ingredient, or component of the container. For a complete listing, 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. 1 4 Geriatrics). • LONGAVO is not indicated for the treatment of patients with dementia-related psychosis. LONGAVO (risperidone) Page 6 of 60 4. 1. Dosing Considerations • For patients who have never taken risperidone, establish tolerability with oral risperidone prior to initiating treatment with LONGAVO.
• Neither a loading dose nor supplemental oral risperidone doses are recommended when switching. • Each injection must be administered subcutaneously monthly by a healthcare professional using the prefilled syringe and enclosed safety needle.
Do not administer by any other route. 4 ADMINISTRATION). Failure to move the bubble to the cap of the syringe could result in incomplete dosage. • Caution should be exercised in patients prone to hypotension, geriatrics, patients with renal impairment and patients with hepatic impairment.
• Very rare cases of severe hypersensitivity after injection with risperidone 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 2 CONTRAINDICATIONS, 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING and 7 WARNINGS AND PRECAUTIONS, Immune, Hypersensitivity).
2. Recommended Dose and Dosage Adjustment • LONGAVO is to be administered as an abdominal or upper arm subcutaneous injection only. Do not administer by any other route. • Each injection must be administered by a healthcare professional using the prefilled syringe and enclosed safety needle.
, 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING and 7 WARNINGS AND PRECAUTIONS, Immune, Hypersensitivity). 2. Recommended Dose and Dosage Adjustment • LONGAVO is to be administered as an abdominal or upper arm subcutaneous injection only.
Do not administer by any other route. • Each injection must be administered by a healthcare professional using the prefilled syringe and enclosed safety needle. • For patients who have never taken risperidone, establish tolerability with oral risperidone prior to starting LONGAVO.
35 mL. 3 Pharmacokinetics), patients previously stabilized on different doses of oral risperidone can attain similar steady-state exposure to the active moiety during maintenance treatment with corresponding LONGAVO monthly doses as shown below: Table 1: LONGAVO Dosage Selection Guide Based on Modelling and Simulation steady state exposure Dosing Regimen LONGAVO Doses LONGAVO Injection Monthly* 50 mg 75 mg 100 mg 125 mg Comparable Oral Doses Daily Oral Risperidone 2 mg 3 mg 4 mg 5 mg *Administer 1 dose per month LONGAVO (risperidone) Page 7 of 60 Patients who are on stable oral risperidone doses lower than 2 mg/day or higher than 5 mg/day may not be candidates for LONGAVO.
3 Pharmacokinetics). 3 Pediatrics). • Geriatrics: Clinical studies of LONGAVO 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.
4 Geriatrics). 3 Pharmacokinetics, Special Populations and Conditions). Before considering initiation of LONGAVO with these patients, tolerability must be established with oral risperidone. 14 mL monthly. • Dosage recommendations for Concomitant Use with Strong CYP2D6 Inhibitors and Strong CYP3A4 Inducers • Co-administration with Strong CYP2D6 Inhibitors When initiation of fluoxetine or paroxetine is considered, patients may be placed on a lower dose of LONGAVO prior to the planned start of fluoxetine or paroxetine therapy to adjust for the expected increase in plasma concentrations of risperidone.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Risperidone in Canada.
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Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents. Hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion. This in turn may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients.
Galactorrhea, amenorrhea, gynecomastia, nonpuerperal lactation, abnormal sexual function, ejaculation failure, decreased libido and impotence have been reported in patients receiving prolactin-elevating compounds. Long-standing hyperprolactinemia may lead to decreased bone density in both female and male patients.
Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro. LONGAVO should only be administered to a patient with previously detected breast cancer if the benefits outweigh the risks.
Caution should also be exercised when considering LONGAVO treatment in patients with pituitary tumours. An increase in pituitary gland, mammary gland, and pancreatic islet cell neoplasia (mammary adenocarcinomas, pituitary and pancreatic adenomas) was observed in the risperidone carcinogenicity studies conducted in mice and rats (see 16 NON-CLINICAL TOXICOLOGY).
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.
Weight Gain Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended (see 8 ADVERSE REACTIONS). Gastrointestinal Antiemetic Effect Consistent with its dopamine antagonistic effects, LONGAVO may have an antiemetic effect.
Such an effect may mask signs of toxicity due to overdosage with other drugs, or may mask symptoms of disease such as brain tumour, or intestinal obstruction or Reye’s syndrome. LONGAVO (risperidone) Page 20 of 60 Dysphagia Esophageal dysmotility and aspiration have been associated with antipsychotic drug use.
Aspiration pneumonia is a common cause of morbidity and mortality in patients with advanced Alzheimer’s dementia. 4 Geriatrics). Genitourinary Priapism Drugs with alpha-adrenergic blocking effects have been reported to induce priapism.
Priapism has been reported with risperidone during post-marketing surveillance. This adverse reaction, as with other psychotropic drugs, did not appear to be dose dependent and did not correlate with the duration of treatment. In a long term safety study, 1 patient treated with LONGAVO monthly dosing regimen experienced priapism.
Hematologic Leukopenia, Neutropenia, and Agranulocytosis In clinical trial and/or post-marketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents, including risperidone. Granulocytopenia and agranulocytosis have also been reported.
Possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC) and a history of drug-induced leukopenia/neutropenia. Patients with a history of a clinically significant low WBC or a drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of LONGAVO should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
Patients with clinically significant neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia (absolute neutrophil count < 1 x 109/L) should discontinue LONGAVO and have their WBC followed […]
• For patients who have never taken risperidone, establish tolerability with oral risperidone prior to starting LONGAVO. 35 mL. 3 Pharmacokinetics), patients previously stabilized on different doses of oral risperidone can attain similar steady-state exposure to the active moiety during maintenance treatment with corresponding LONGAVO monthly doses as shown below: Table 1: LONGAVO Dosage Selection Guide Based on Modelling and Simulation steady state exposure Dosing Regimen LONGAVO Doses LONGAVO Injection Monthly* 50 mg 75 mg 100 mg 125 mg Comparable Oral Doses Daily Oral Risperidone 2 mg 3 mg 4 mg 5 mg *Administer 1 dose per month LONGAVO (risperidone) Page 7 of 60 Patients who are on stable oral risperidone doses lower than 2 mg/day or higher than 5 mg/day may not be candidates for LONGAVO.
3 Pharmacokinetics). 3 Pediatrics). • Geriatrics: Clinical studies of LONGAVO 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.
4 Geriatrics). 3 Pharmacokinetics, Special Populations and Conditions). Before considering initiation of LONGAVO with these patients, tolerability must be established with oral risperidone. 14 mL monthly. • Dosage recommendations for Concomitant Use with Strong CYP2D6 Inhibitors and Strong CYP3A4 Inducers • Co-administration with Strong CYP2D6 Inhibitors When initiation of fluoxetine or paroxetine is considered, patients may be placed on a lower dose of LONGAVO prior to the planned start of fluoxetine or paroxetine therapy to adjust for the expected increase in plasma concentrations of risperidone.
4 Drug-Drug Interactions). The effects of discontinuation of concomitant fluoxetine or paroxetine therapy on the pharmacokinetics of risperidone and 9-hydroxyrisperidone have not been studied. • Co-administration with Strong CYP3A4 Inducers At the initiation of therapy with carbamazepine or other known hepatic enzyme inducers, patients should be closely monitored during the first 4 to 8 weeks since the dose of LONGAVO may need to be adjusted.
A dose increase, or additional oral risperidone, may be considered. On discontinuation of carbamazepine or […]
4 Drug-Drug Interactions). The effects of discontinuation of concomitant fluoxetine or paroxetine therapy on the pharmacokinetics of risperidone and 9-hydroxyrisperidone have not been studied. • Co-administration with Strong CYP3A4 Inducers At the initiation of therapy with carbamazepine or other known hepatic enzyme inducers, patients should be closely monitored during the first 4 to 8 weeks since the dose of LONGAVO may need to be adjusted.
A dose increase, or additional oral risperidone, may be considered. On discontinuation of carbamazepine or other CYP3A4 enzyme inducers, the dosage of LONGAVO should be re-evaluated and, if necessary, decreased. Patients may be placed on a lower dose of LONGAVO upon discontinuation of carbamazepine or other CYP3A4 enzyme inducers to adjust for the expected increase in plasma concentrations of risperidone plus 9-hydroxyrisperidone.
4 Drug-Drug Interactions). The effects of discontinuation of concomitant carbamazepine therapy on the pharmacokinetics of risperidone and 9-hydroxyrisperidone have not been studied. • Switching Antipsychotic Agents There are no data to specifically address switching patients with schizophrenia from other antipsychotics to LONGAVO or concerning concomitant administration with other antipsychotics.
Discontinuation of the previous antipsychotic should be made in accordance with the appropriate prescribing information. 4. Administration IMPORTANT ADMINISTRATION INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS INSTRUCTION FOR USE You must read all the steps of the instructions before you administer LONGAVO for the first time.
• For subcutaneous injection only. Do not inject any other route. • To be administered by a healthcare professional only • Allow LONGAVO to come to room temperature for at least 30 minutes prior to administration. • As a universal precaution, always wear gloves.
STEP 1 Check to make sure LONGAVO kit contains: • One sterile single-dose, prefilled glass syringe • One sterile 21G x 5/8” needle Do not substitute any components of the kit for administration. Prefilled Syringe Safety Needle LONGAVO (risperidone) Page 9 of 60 STEP 2 Remove LONGAVO kit from refrigerated storage and allow the package to sit at room temperature (20 to 25°C) for at least 30 minutes.
At room temperature Note:
LONGAVO is solid at refrigerated temperatures and must reach room temperature prior to administration. Do not warm any other way and keep protected from light. STEP 3 Check that the […]