VALTAXIN SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VALRUBICIN

Available from:

ENDO PHARMACEUTICALS SOLUTIONS INC

ATC code:

L01DB09

INN (International Name):

VALRUBICIN

Dosage:

40MG

Pharmaceutical form:

SOLUTION

Composition:

VALRUBICIN 40MG

Administration route:

INTRAVESICAL

Units in package:

5 ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0141241001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2017-08-01

Summary of Product characteristics

PRODUCT MONOGRAPH
VALTAXIN
® (VALRUBICIN) STERILE SOLUTION FOR INTRAVESICAL INSTILLATION
200 MG/5ML
CYTOTOXIC ANTINEOPLASTIC ANTI-CANCER AGENT
ENDO PHARMACEUTICALS SOLUTIONS INC.
100 CHADDS FORD, PENNYSLVANIA 19317
DISTRIBUTED BY:
PALADIN LABS, INC.
100 BLVD ALEXIS NIHON, SUITE 600 ST. LAURENT, QUÉBEC,
CANADA H4M 2P2
DATE OF PREPARATION:
OCTOBER 26, 2009
CONTROL #: 132619
PRODUCT MONOGRAPH
VALTAXIN (VALRUBICIN)
STERILE SOLUTION FOR INTRAVESICAL INSTILLATION
CYTOTOXIC ANTINEOPLASTIC ANTI-CANCER AGENT
DOSAGE FORM SUMMARY TABLE
VIAL
SIZE
VIAL CONTENTS
DOSAGE
STRENGTH
DOSAGE
FORM
AVAILABILITY OF
DOSAGE FORMS
NONMEDICINAL
INGREDIENTS
5 mL
Each vial of Valtaxin contains
valrubicin at a concentration of
40 mg/mL in 50% ® EL
(Polyoxyl 35 castor oil, NF)
without preservatives or other
additives.
The solution is sterile and
nonpyrogenic.
40
mg/mL
Sterile
Solution
Carton of 4, 5 mL
single-use vials (200
mg/5 mL)
Carton of 24, 5 mL
single-use vials (200
mg/5 mL)
Cremophor® EL
(Polyoxyl 35
castor
oil, NF)
Dehydrated
alcohol,
USP
ACTION AND CLINICAL PHARMACOLOGY
PHARMACOLOGY
MECHANISM OF ACTION:
Valrubicin is an anthracycline that affects a variety of inter-
related biological functions, most of which involve nucleic acid
metabolism. It readily
penetrates into cells, where it inhibits the incorporation of
nucleosides into nucleic acids,
causes extensive chromosomal damage, and arrests cell cycle in G2.
Although valrubicin
does not bind strongly to DNA, a principal mechanism of its action,
mediated by
valrubicin metabolites, is interference with the normal DNA
breaking-resealing action of
DNA topoisomerase II.
PHARMACOKINETICS AFTER INTRAVESICAL ADMINISTRATION OF VALTAXIN
: When an 800
mg dose of VALTAXIN was administered intravesically to patients with
carcinoma in
situ, VALTAXIN penetrated into the bladder wall. The mean total
anthracycline
concentration measured in bladder tissue exceeded the levels causing
90% cytotoxicity to
human bladder cells cultured
_in vitro_
. During the two-hour dose retention period, the
metabo