Land: Canada
Sprog: engelsk
Kilde: Health Canada
CYCLOPHOSPHAMIDE
BRISTOL-MYERS SQUIBB CANADA
L01AA01
CYCLOPHOSPHAMIDE
2000MG
POWDER FOR SOLUTION
CYCLOPHOSPHAMIDE 2000MG
INTRAVENOUS
2G
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0107630004; AHFS:
CANCELLED POST MARKET
2008-10-17
PRODUCT MONOGRAPH CYTOXAN* (CYCLOPHOSPHAMIDE) STERILE POWDER 100, 750, 1000 AND 2000 MG, U.S.P. TABLETS 25 AND 50 MG, U.S.P. ANTINEOPLASTIC AGENT Bristol-Myers Squibb Canada 2365 Côte de Liesse Rd Date of Preparation: Montreal, Canada. November 2, 2004 H4N 2M7 * TM of Mead Johnson & Company Date of Revision: used under license by Bristol-Myers Squibb Canada Control No.: 094703 1 PRODUCT MONOGRAPH CYTOXAN * (CYCLOPHOSPHAMIDE) Sterile powder 100, 750, 1000 and 2000 mg, U.S.P. Tablets 25 and 50 mg, U.S.P. THERAPEUTIC CLASSIFICATION Antineoplastic Agent CAUTION CYTOXAN IS A POTENT DRUG AND SHOULD BE USED ONLY BY PHYSICIANS EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC DRUGS (SEE WARNINGS AND PRECAUTIONS). IN THOSE PATIENTS WHO DEVELOP BACTERIAL, FUNGAL, OR VIRAL INFECTIONS, MODIFICATION OF DOSAGE SHOULD BE CONSIDERED. BLOOD COUNTS SHOULD BE TAKEN AT REGULAR INTERVALS. ACTION AND CLINICAL PHARMACOLOGY Cyclophosphamide is activated by metabolism in the liver by the mixed-function oxidase system of the smooth endoplasmic reticulum. The hepatic cytochrome P-450 mixed-function converts cyclophosphamide to 4-hydroxycyclophosphamide, which is in a steady state with the acyclic tautomer, aldophosphamide. The drug and its metabolites are distributed throughout the body including the brain. Cyclophosphamide, which is biologically relatively inactive, is eliminated from the body very slowly. The activated metabolites alkylate the target sites in susceptible cells in an "all-or-none" type of reaction or are detoxicated by formation of inactive metabolites that are rapidly excreted by the kidneys. INDICATIONS AND CLINICAL USES A. Frequently responsive myeloproliferative and lymphoproliferative disorders: 1. Malignant lymphomas (Stages II to IV) a) Hodgkin's disease b) Mixed-cell type lymphoma c) Lymphocytic lymphoma d) Histiocytic lymphoma e) Lymphoblastic lymphosarcoma f) Burkitt's lymphoma 2. Multiple myeloma. 3. Leukemias: a) Chronic lymphocytic leukemia b) Chronic granulocytic leukemia (it is ineffective in acute blastic crises) Læs hele dokumentet