Država: Kanada
Jezik: angleščina
Source: Health Canada
LOMUSTINE
BRISTOL-MYERS SQUIBB CANADA
L01AD02
LOMUSTINE
10MG
CAPSULE
LOMUSTINE 10MG
ORAL
20
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0111021002; AHFS:
APPROVED
2009-02-19
Page 1 of 20 PRODUCT MONOGRAPH PR CEENU* (LOMUSTINE-CCNU) CAPSULES; 10, 40 AND 100 MG ANTINEOPLASTIC AGENT Bristol-Myers Squibb Canada Date of Preparation: Montreal, Canada, H4S 0A4 4 July 1974 * TM of Bristol-Myers Squibb Company Date of Revision: used under license by Bristol-Myers Squibb Canada February 17, 2016 Submission control no.: 188932 Page 2 of 20 PRODUCT MONOGRAPH NAME OF DRUG CEENU (LOMUSTINE - CCNU) Capsules; 10, 40 and 100 mg THERAPEUTIC CLASSIFICATION Antineoplastic Agent CAUTION: CeeNU (LOMUSTINE-CCNU) IS A POTENT DRUG AND SHOULD BE USED ONLY BY PHYSICIANS EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC DRUGS (SEE WARNINGS AND PRECAUTIONS). BLOOD COUNTS AS WELL AS RENAL AND HEPATIC FUNCTION TESTS SHOULD BE TAKEN REGULARLY. DISCONTINUE THE DRUG IF ABNORMAL DEPRESSION OF BONE MARROW IS SEEN. ACTION AND CLINICAL PHARMACOLOGY It is generally agreed that CeeNU (lomustine-CCNU) acts as an alkylating agent but, as with other nitrosoureas, it may also inhibit several key enzymatic processes. CeeNU may be given orally. Following oral administration of radioactive CeeNU at doses ranging from 30 mg/m 2 to 100 mg/m 2 about half of the radioactivity given was excreted within 24 hours. The serum half-life of the drug and/or metabolites ranges from 16 hours to 2 days. Tissue levels are comparable to plasma levels at 15 minutes after intravenous administration. Because of the high lipid solubility and the relative lack of ionization at a physiological pH, CeeNU crosses the blood-brain barrier quite effectively. Levels of radioactivity in the CSF are 50 percent or greater than those measured concurrently in plasma. Page 3 of 20 INDICATIONS AND CLINICAL USES CeeNU (lomustine-CCNU) is indicated as palliative therapy in addition to surgery and radiotherapy or in combination therapy with other chemotherapeutic agents in the following: 1. Brain tumors - both primary and metastatic, in patients who have already received appropriate surgical and/or radiotherapeutic procedures. 2. Hodgkin's Disease – as a secondary therapy, a Preberite celoten dokument