Kraj: Kanada
Język: angielski
Źródło: Health Canada
TAMOXIFEN (TAMOXIFEN CITRATE)
PHARMEL INC
L02BA01
TAMOXIFEN
10MG
TABLET
TAMOXIFEN (TAMOXIFEN CITRATE) 10MG
ORAL
250
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0131293001; AHFS:
CANCELLED POST MARKET
2016-10-25
PRODUCT MONOGRAPH PR TAMOXIFEN (Tamoxifen Citrate Tablets, USP) 10 mg & 20 mg ANTINEOPLASTIC AGENT PHARMEL INC. DATE OF PREPARATION: 8699 8 TH Avenue March 10, 1998 Montreal, CANADA H1Z 2X4 DATE OF REVISION: September 11, 2003 CONTROL #083923 -2- PRODUCT MONOGRAPH PR TAMOXIFEN (Tamoxifen Citrate Tablets USP) 10 mg & 20 mg THERAPEUTIC CLASSIFICATION Antineoplastic Agent T AMOXIFEN THERAPY WAS ASSOCIATED WITH SERIOUS AND LIFE - THREATENING EVENTS INCLUDING UTERINE MALIGNANCIES , STROKE , PULMONARY EMBOLISM , AND DEEP VEIN THROMBOSIS IN THE NSABP P -1 BREAST CANCER PREVENTION TRIAL . T HE USE OF TAMOXIFEN FOR BREAST CANCER PREVENTION IS NOT AN APPROVED INDICATION IN CANADA . T HE FOLLOWING RISKS ASSOCIATED WITH TAMOXIFEN THERAPY HAVE BEEN ESTIMATED FROM THE NSABP P -1 BREAST CANCER PREVENTION TRIAL . T HE RELATIVE RISK OF TAMOXIFEN COMPARED TO PLACEBO WAS 3.1 FOR ENDOMETRAIL CANCER , 4.0 FOR UTERINE SARCOMAS , 1.6 FOR STROKE , 3.0 FOR PULMONARY EMBOLISM , AND 1.6 FOR DEEP VEIN THROMBOSIS . T HESE EVENTS WERE FATAL IN SOME PATIENTS . H EALTH CARE PROVIDERS SHOULD BE AWARE OF THE POSSIBLE RISKS ASSOCIATED WITH TAMOXIFEN THERAPY AND SHOULD DISCUSS THEM WITH THEIR PATIENTS . T HE BENEFITS OF TAMOXIFEN THERAPY OUTWEIGH THE RISKS IN THE MAJORITY OF WOMEN BEING TREATED ACCORDING TO THE APPROVED CANADIAN INDICATION FOR THE TREATMENT OF BREAST CANCER . -3- ACTION AND CLINICAL PHARMACOLOGY Tamoxifen citrate is a non-steroidal agent which has demonstrated potent antiestrogenic properties in animal test systems. The antiestrogenic effects are related to its ability to compete with estrogen for binding sites in target tissues such as breast and uterus. Tamoxifen inhibits the induction of rat mammary carcinoma induced by dimethylbenzanthracene (DMBA), and causes the regression of already established DMBA induced tumors. In this rat model, tamoxifen appears to exert its antitumor effects by binding to estrogen receptors. In cytosols derived from human endometrium and human breast and uterine adenocarcinomas, tamoxifen competes wit Przeczytaj cały dokument