CEENU CAPSULE

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

LOMUSTINE

Dostępny od:

BRISTOL-MYERS SQUIBB CANADA

Kod ATC:

L01AD02

INN (International Nazwa):

LOMUSTINE

Dawkowanie:

10MG

Forma farmaceutyczna:

CAPSULE

Skład:

LOMUSTINE 10MG

Droga podania:

ORAL

Sztuk w opakowaniu:

20

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANTINEOPLASTIC AGENTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0111021002; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2009-02-19

Charakterystyka produktu

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