EMCYT CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ESTRAMUSTINE PHOSPHATE SODIUM

Available from:

PFIZER CANADA ULC

ATC code:

L01XX11

INN (International Name):

ESTRAMUSTINE

Dosage:

140MG

Pharmaceutical form:

CAPSULE

Composition:

ESTRAMUSTINE PHOSPHATE SODIUM 140MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0113371001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2020-04-30

Summary of Product characteristics

1
PRODUCT MONOGRAPH
PR
EMCYT*
(estramustine sodium phosphate capsules B.P.)
140 mg/capsule
ANTINEOPLASTIC
Pfizer Canada Inc
Date of Revision:
17,300 Trans-Canada Highway
10 December 2015
Kirkland, Quebec H9J 2M5
Control No. 186447
*
TM Pharmacia AB
Pfizer Canada Inc, Licensee

Pfizer Canada Inc 2015
2
PRODUCT MONOGRAPH
NAME OF DRUG
PR
EMCYT
Estramustine sodium phosphate capsules B.P.
THERAPEUTIC CLASSIFICATION
Antineoplastic
CAUTION: EMCYT (ESTRAMUSTINE SODIUM PHOSPHATE) IS A POTENT DRUG AND
SHOULD BE PRESCRIBED ONLY BY PHYSICIANS EXPERIENCED WITH CANCER
CHEMOTHERAPEUTIC DRUGS (SEE WARNINGS & PRECAUTIONS). BLOOD
COUNTS, AS WELL AS RENAL AND HEPATIC FUNCTION TESTS, SHOULD BE
PERFORMED REGULARLY. DISCONTINUE THE DRUG IF ABNORMAL RENAL OR
HEPATIC FUNCTION IS SEEN. CAPSULES SHOULD NOT BE OPENED.
ACTION
Emcyt (estramustine sodium phosphate) has a dual mode of action. The
intact molecule acts as
an anti-mitotic agent and after hydrolysis of the carbamate ester
bridge the released estrogens
exert an anti-gonadotrophic effect.
The low level of clinically manifested side effects may be due to the
fact that estramustine binds
to a protein present in the tumor tissue, which results in an
accumulation of the drug at the target
site.
3
INDICATIONS
The treatment of metastatic prostatic carcinoma (stage D) in patients
whose disease is refractory
to hormonal therapy. Emcyt (estramustine sodium phosphate) may produce
either a stabilization
or regression of the disease process and improvement in ability to
function.
CONTRAINDICATIONS
Emcyt should not be used in patients with any of the following
conditions:
*
known hypersensitivity to either estradiol or to nitrogen mustard
*
severe hepatic or cardiac disease
*
active thrombophlebitis or thromboembolic disorders
WARNINGS
Emcyt (estramustine sodium phosphate) should be used with caution in
patients with a history of
thrombophlebitis, thrombosis or thromboembolic disorders, especially
if associated with
estrogen therapy. Caution should also be used in patients with
cerebral vascu