ETOPOSIDE INJECTION LIQUID

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ETOPOSIDE

Available from:

FRESENIUS KABI CANADA LTD

ATC code:

L01CB01

INN (International Name):

ETOPOSIDE

Dosage:

20MG

Pharmaceutical form:

LIQUID

Composition:

ETOPOSIDE 20MG

Administration route:

INTRAVENOUS

Units in package:

250ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0114567002; AHFS:

Authorization status:

APPROVED

Authorization date:

2006-10-04

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
ETOPOSIDE INJECTION
(Etoposide)
20 mg/mL
USP
Antineoplastic agent
FRESENIUS KABI CANADA LTD.
Date of Revision:
165 Galaxy Blvd, Suite 100
May 10, 2017
Toronto, ON M9W 0C8
Submission Control No.: 196647
_Etoposide Injection-Product Monograph _
_ _
_Page 2 of 26 _
PRODUCT MONOGRAPH
PR
ETOPOSIDE INJECTION
20 mg/mL
USP
THERAPEUTIC CLASSIFICATION
Antineoplastic agent
CAUTION: ETOPOSIDE IS A POTENT DRUG AND SHOULD BE USED ONLY BY
QUALIFIED PHYSICIANS EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC
DRUGS (SEE WARNINGS AND PRECAUTIONS). SEVERE MYELOSUPPRESSION
WITH RESULTING INFECTION OR BLEEDING MAY OCCUR. BLOOD COUNTS
AS WELL AS RENAL AND HEPATIC FUNCTION TESTS SHOULD BE TAKEN
REGULARLY. DISCONTINUE THE DRUG IF ABNORMAL DEPRESSION OF BONE
MARROW OR ABNORMAL RENAL OR HEPATIC FUNCTION IS SEEN.
ETOPOSIDE INJECTION CONTAINS POLYSORBATE 80. IN PREMATURE
INFANTS, A LIFE THREATENING SYNDROME OF LIVER AND RENAL FAILURE,
PULMONARY DETERIORATION, THROMBOCYTOPENIA AND ASCITES HAS
BEEN ASSOCIATED WITH INJECTABLE VITAMIN E PRODUCT CONTAINING
POLYSORBATE 80.
ETOPOSIDE INJECTION
CONTAINS
BENZYL
ALCOHOL.
BENZYL ALCOHOL HAS BEEN ASSOCIATED WITH AN
INCREASED
INCIDENCE OF
NEUROLOGICAL
AND OTHER
COMPLICATIONS
IN
NEWBORN
INFANTS WHICH ARE
SOMETIMES FATAL.
ACTION AND CLINICAL PHARMACOLOGY
Etoposide is a semi-synthetic derivative of podophyllotoxin used in
the treatment of certain
neoplastic diseases.
_In vitro_, etoposide has cytostatic action, which prevents the cells
from entering mitosis or
destroys them in the premitotic phase. Etoposide interferes with the
synthesis of DNA and has a
secondary effect on arresting cells in resting (G
2
) phase in experiments with human
lymphoblastic cell lines.
_Etoposide Injection-Product Monograph _
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_Page 3 of 26 _
Etoposide has a marked action on human hemopoietic cells causing
leukopenia and
thrombocytopenia. Animal experiments have shown evidence of
teratogenicity.
An intravenous dose (259 mg/m
2
) of tritium-labelled etoposide given over one hour in man,
showed the mean volume of