MITOMYCIN FOR INJECTION USP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MITOMYCIN

Available from:

ACCORD HEALTHCARE INC

ATC code:

L01DC03

INN (International Name):

MITOMYCIN

Dosage:

20MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

MITOMYCIN 20MG

Administration route:

INTRAVENOUS

Units in package:

39ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0111533002; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-06-09

Summary of Product characteristics

PRODUCT MONOGRAPH
Pr
MITOMYCIN FOR
INJECTION USP
20 mg mitomycin per
vial
Sterile Lyophilized
powder
Antineoplastic Agent
Accord Healthcare Inc.
3535 Boul. St-Charles, Suite 704
Kirkland, Qc H9H 5B9
Canada
Date of Revision:
July 16, 2018
Control #: 216814
Page 2 of 16
PRODUCT
MONOGRAPH
PR
MITOMYCIN FOR INJECTION USP
20 mg mitomycin per
vial
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
CAUTION: MITOMYCIN IS A POTENT DRUG AND SHOULD BE USED ONLY BY
PHYSICIANS EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC DRUGS (SEE
WARNINGS AND PRECAUTIONS). BLOOD COUNTS SHOULD BE TAKEN WEEKLY.
MITOMYCIN MUST BE DISCONTINUED OR DOSAGE REDUCED UPON EVIDENCE
OF ABNORMAL DEPRESSION OF THE BONE MARROW OR THE DEVELOPMENT
OF SIGNIFICANT RENAL OR PULMONARY TOXICITY.
ACTION AND CLINICAL PHARMACOLOGY
Mitomycin was first investigated as an antibiotic in Japan.
It was then found to be active as an
antineoplastic agent.
It selectively inhibits the synthesis of deoxyribonucleic acid (DNA).
The
exact point of mitomycin attachment to DNA remains unknown. There is a
correlation between the
guanine and cytosine content of DNA and the degree of
mitomycin-induced cross-linking. At high
concentrations of the drug, cellular RNA and protein synthesis are
also suppressed.
In humans, mitomycin is rapidly cleared from the plasma after
intravenous administration with a
biphasic plasma elimination curve. Time required to reduce the serum
concentration by 50%
after
a
30 mg bolus injection is 17 minutes. After injection of 30 mg, 20 mg
or 10 mg intravenously, the
maximal serum concentrations were 2.4
µg
/ mL, 1.7
µg
/ mL and 0.52
µg
/ mL, respectively.
In general, the smaller the dose, the more rapidly blood levels of
mitomycin decreased. Clearance is
affected primarily by metabolism in the liver, but metabolism occurs
in other tissues as well.
Approximately 10% of a dose of mitomycin is excreted unchanged in the
urine. Since metabolic
pathways are saturated at relatively low doses, the percent of a dose
excreted in urine increases
with increasing doses. In c