AMSA PD LIQUID

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AMSACRINE

Available from:

SEARCHLIGHT PHARMA INC

ATC code:

L01XX01

INN (International Name):

AMSACRINE

Dosage:

50MG

Pharmaceutical form:

LIQUID

Composition:

AMSACRINE 50MG

Administration route:

INTRAVENOUS

Units in package:

1.5ML/AMPOULE

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0115748001; AHFS:

Authorization status:

APPROVED

Authorization date:

2001-01-05

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
AMSA PD*
AMSACRINE INJECTION
75 MG/1.5 ML AMPOULE
(50 MG/ML)
ANTINEOPLASTIC AGENT
Searchlight Pharma Inc.
1600 Notre-Dame West, suite 312
Montreal, Quebec
H3J 1M1
Submission Control No.: 267638
Date of Preparation:
OCT 25, 2022
2
PR
AMSA PD
AMSACRINE INJECTION
75 MG AMPOULE
CAUTION: AMSA PD IS A POTENT DRUG AND SHOULD BE USED ONLY BY
PHYSICIANS
EXPERIENCED
WITH
CANCER
CHEMOTHERAPEUTIC
DRUGS
(SEE
WARNINGS AND PRECAUTIONS). FACILITIES SHOULD BE AVAILABLE FOR THE
MANAGEMENT OF BONE MARROW SUPPRESSION. PERIODIC MONITORING OF
BONE MARROW AND PERIPHERAL BLOOD SHOULD BE DONE. IN ADDITION LIVER
AND RENAL FUNCTION MUST BE EVALUATED, PRIOR AND DURING AMSA PD
THERAPY.
PHARMACOLOGICAL CLASSIFICATION
Antineoplastic Agent
ACTION AND CLINICAL PHARMACOLOGY
AMSA PD is a potent cytotoxic agent. In in vitro studies, the LD
50
against cultured L1210 cells
is 0.04 µg/ml and 0.2 µg/ml against cultured Novikoff cells at six
hours. Higher concentrations or
longer exposure produce cell destruction. A three-hour exposure of
Novikoff cells to 2 µg of
AMSA PD indicated 62% inhibition of DNA synthesis (incorporation of
radioactive thymidine)
while RNA synthesis was not affected (incorporation of radioactive
uridine). Essentially the same
results were obtained in vivo when L1210-inoculated mice were treated
with a dose of 0.1
mg/mouse. AMSA PD binds to DNA both through intercalation and external
binding and has base
specificity for A-T pairs.
3
Cycling cells are two to four times more sensitive to AMSA PD than are
resting cells. Cycling
cells initially in S and G2 phases were grossly delayed in their
capacity for normal progression,
leading to a transitory (approximately eight hours) accumulation of
cells in S phase, followed at
later times by arrest in G2 phase. A limited degree of mitotic
nondisjunction and a high degree of
polyploidization
was
seen.
Examination
of
chromosome
damage
indicated
incomplete
condensation and chromosome stickiness, which are characteristics of
DNA intercalators.
AMSA PD is active against a