CISPLATIN INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CISPLATIN

Available from:

FRESENIUS KABI CANADA LTD

ATC code:

L01XA01

INN (International Name):

CISPLATIN

Dosage:

1MG

Pharmaceutical form:

SOLUTION

Composition:

CISPLATIN 1MG

Administration route:

INTRAVENOUS

Units in package:

50/100/200ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0113245002; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-05-19

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
CISPLATIN INJECTION
1 mg/mL
(50 mg/50 mL, 100 mg/100 mL, 200 mg/200 mL)
Antineoplastic Agent
FRESENIUS KABI CANADA LTD.
Date of Revision:
45 Vogell Rd, Suite 200
September 30, 2016
Richmond Hill, ON, L4B 3P6
Submission Control No.: 198375
_Cisplatin-PM-ENG-v2.0 _
_Page 2 of 19_
PR
CISPLATIN INJECTION
CAUTION
CISPLATIN
INJECTION
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, OR ABNORMAL RENAL OR
HEPATIC FUNCTION IS SEEN.
ACTION AND CLINICAL PHARMACOLOGY
Cisplatin has biochemical properties similar to those of bifunctional
alkylating agents producing inter-
strand and intra-strand cross-links in DNA. It is apparently not
cell-cycle specific.
PHARMACOKINETICS
Following bolus injection or intravenous infusion over 2 to 7 hours,
of doses ranging from 50 to 100
mg/m
2
, plasma cisplatin half-life is approximately 30 minutes. The ratios
of cisplatin to total, free
(ultrafilterable) platinum in the plasma range from 0.4 to 1.1 after a
dose of
100 mg/m
2
.
Cisplatin does not undergo instantaneous and reversible binding to
plasma proteins characteristic of
normal drug-protein binding. However, the platinum from cisplatin
becomes bound to plasma
proteins. These complexes are slowly eliminated with a half-life of 5
days or more.
Following cisplatin doses of 20 to 120 mg/m
2
, the concentration of platinum is highest in liver,
prostate and kidney, somewhat lower in bladder, muscle, testicle,
pancreas and spleen and lowest in
bowel, adrenal, heart, lung, cerebrum and cerebellum. Platinum is
present in tissues for as long as 180
days after the last administration. With the exception of
intracerebral tumors, platinum concentrations
in tumors are generally somewhat lower than the concentrations in the
organ where the tumor is
located. Different metastatic sites in the same patient m