Loading…
AURO-CLOZAPINE is a brand name for Clozapine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ). Auro Pharma Inc. will provide the Non-rechallengeable Status/Hematological Status of patients to the requesting approved suppliers2 of clozapine within 24 hours of receipt of a written request (see 1 INDICATIONS). The dosage of Auro-Clozapine must be adjusted individually. For each patient the lowest effective dose…
Verbatim from this product's HC label. Tap a section to expand.
Auro-Clozapine is available only through a distribution system Auro-Clozapine Risk Management Program that ensures weekly, every-two-week or every-four-week hematological testing prior to the dispensing of the next period's supply of Auro-Clozapine (see 7 WARNINGS AND PRECAUTIONS, Hematologic).
This requires: • all patients taking clozapine, the physician must have obtained consent from the patient; and registration of the patient, their current location, treating physician, testing laboratory and dispensing pharmacist in the Auro-Clozapine Risk Management Program.
• maintenance of a national Auro Pharma Inc specific database that enables the monitoring system of the hematological results of all patients on Auro-Clozapine and provides timely feedback (within 24 hours of receipt of the blood test results) to the treating physician and dispensing pharmacist/or pharmacy • the ability to identify patients who have been assigned "Non-rechallengeable Status" (see 7 WARNINGS AND PRECAUTIONS).
This requires that Auro Pharma Inc. both provide to, and obtain from, all other approved suppliers1 of clozapine, the Non- rechallengeable Status / Hematological Status of all patients (see 4 DOSAGE AND ADMINISTRATION). Auro Pharma Inc.
must be able to provide this information within 24 hours of receiving a written request. 1 “approved supplier” is a manufacturer who holds a valid Notice of Compliance (NOC) for clozapine Auro-Clozapine (Product Monograph) Page 5 of 49 Physicians should not prescribe Auro-Clozapine until the non-rechallengeable status and the hematological status of the patient has been verified.
For the distribution system to be effective, treating physicians must ensure that the hematological testing is performed at the required frequency (see 7 WARNINGS AND PRECAUTIONS, Hematologic) and that arrangements are made for the hematological results to be sent to Auro-Clozapine Risk Management Program distribution system.
Physicians may obtain details on the Risk Management Program by calling a toll-free phone number (1-855-648-6681). Other Monitoring and Distribution Systems Between 1991 and 2003, clozapine was distributed by a single manufacturer, and patients were monitored by this manufacturer's specific registry and distribution system.
The introduction of clozapine from other manufacturers has now resulted in the establishment of manufacturer- specific registry and distribution systems. In order to ensure the safe use and continued monitoring of all patients taking clozapine, the physician must have obtained consent from the patient for the potential sharing of hematological and other safety data between clozapine registries.
, Hematologic and 4 DOSAGE AND ADMINISTRATION. Auro-Clozapine is available only through a distribution system Auro-Clozapine Risk Management Program that ensures weekly, every-two-week or every-four-week hematological testing prior to the dispensing of the next period's supply of Auro-Clozapine (see 7 WARNINGS AND PRECAUTIONS, Hematologic).
This requires: • all patients taking clozapine, the physician must have obtained consent from the patient; and registration of the patient, their current location, treating physician, testing laboratory and dispensing pharmacist in the Auro-Clozapine Risk Management Program.
• maintenance of a national Auro Pharma Inc specific database that enables the monitoring system of the hematological results of all patients on Auro-Clozapine and provides timely feedback (within 24 hours of receipt of the blood test results) to the treating physician and dispensing pharmacist/or pharmacy • the ability to identify patients who have been assigned "Non-rechallengeable Status" (see 7 WARNINGS AND PRECAUTIONS).
This requires that Auro Pharma Inc. both provide to, and obtain from, all other approved suppliers1 of clozapine, the Non- rechallengeable Status / Hematological Status of all patients (see 4 DOSAGE AND ADMINISTRATION). Auro Pharma Inc.
must be able to provide this information within 24 hours of receiving a written request. 1 “approved supplier” is a manufacturer who holds a valid Notice of Compliance (NOC) for clozapine Auro-Clozapine (Product Monograph) Page 5 of 49 Physicians should not prescribe Auro-Clozapine until the non-rechallengeable status and the hematological status of the patient has been verified.
For the distribution system to be effective, treating physicians must ensure that the hematological testing is performed at the required frequency (see 7 WARNINGS AND PRECAUTIONS, Hematologic) and that arrangements are made for the hematological results to be sent to Auro-Clozapine Risk Management Program distribution system.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Clozapine in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Patients may not be switched from one brand of clozapine to another without the completion of a new registry-specific patient registration form signed by the prescribing physician. If a patient is switched from one brand of clozapine to another, the frequency of hematological monitoring may continue unaltered unless a change is clinically indicated.
1 Pediatrics Pediatrics (< 18 years of age): No pediatric studies have been performed. The safety and efficacy of clozapine in children and adolescents have not been established. No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
4 Geriatrics. 2 Recommended Dose and Dosage Adjustment, Dosing Considerations in Special Populations. 2 Contraindications • Auro-Clozapine (clozapine) is contraindicated in patients who are hypersensitive to clozapine or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
Physicians may obtain details on the Risk Management Program by calling a toll-free phone number (1-855-648-6681). Other Monitoring and Distribution Systems Between 1991 and 2003, clozapine was distributed by a single manufacturer, and patients were monitored by this manufacturer's specific registry and distribution system.
The introduction of clozapine from other manufacturers has now resulted in the establishment of manufacturer- specific registry and distribution systems. In order to ensure the safe use and continued monitoring of all patients taking clozapine, the physician must have obtained consent from the patient for the potential sharing of hematological and other safety data between clozapine registries.
Patients may not be switched from one brand of clozapine to another without the completion of a new registry-specific patient registration form signed by the prescribing physician. If a patient is switched from one brand of clozapine to another, the frequency of hematological monitoring may continue unaltered unless a change is clinically indicated.
1 Pediatrics Pediatrics (< 18 years of age): No pediatric studies have been performed. The safety and efficacy of clozapine in children and adolescents have not been established. No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
4 Geriatrics. 2 Recommended Dose and Dosage Adjustment, Dosing Considerations in Special Populations. 2 Contraindications • Auro-Clozapine (clozapine) is contraindicated in patients who are hypersensitive to clozapine 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. • Patients with myeloproliferative disorders, a history of toxic or idiosyncratic agranulocytosis or severe granulocytopenia (with the exception of granulocytopenia/ agranulocytosis from previous chemotherapy).
[Clozapine should not be used simultaneously with other agents known to Auro-Clozapine (Product Monograph) Page 6 of 49 suppress bone marrow function]. • Patients with active liver disease associated with nausea, anorexia, or jaundice; progressive liver disease; hepatic failure.
• Patients unable to undergo blood tests. , myocarditis), paralytic ileus, uncontrolled epilepsy. 5 x 109/L. Severe neutropenia can lead to serious infection and death. 0 x 109/L for patients with documented Benign Ethnic Neutropenia (BEN).
Regular hematologic monitoring is required prior to dispensing, because of the significant risk of this potentially life-threatening adverse event (see 7 WARNINGS AND PRECAUTIONS, Hematologic). Advise patients to immediately report the appearance of lethargy, weakness, fever, sore throat, flu-like complaints or any other signs of infection.
Because of the risk of severe neutropenia, Auro-Clozapine is available only through a distribution system Auro-Clozapine Risk Management Program that ensures weekly, every-two-week or every- four-week hematological testing prior to the dispensing of the next period's supply of Auro-Clozapine (see 7 WARNINGS AND PRECAUTIONS).
Myocarditis, Pericarditis, and Cardiomyopathy and Mitral Valve Incompetence Fatal myocarditis and cardiomyopathy have occurred with the use of clozapine. […]