NOVANTRONE LIQUID

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE)

Available from:

WYETH CANADA

ATC code:

L01DB07

INN (International Name):

MITOXANTRONE

Dosage:

2MG

Pharmaceutical form:

LIQUID

Composition:

MITOXANTRONE (MITOXANTRONE HYDROCHLORIDE) 2MG

Administration route:

INTRAVENOUS

Units in package:

10/12.5ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0116465001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2005-08-10

Summary of Product characteristics

COMPLETE PRESCRIBING INFORMATION
Pr
NOVANTRONE
®
Mitoxantrone for Injection Concentrate USP
INTRAVENOUS INFUSION
ANTINEOPLASTIC AGENT
STERILE
©
WYETH CANADA
DATE OF PREPARATION:
MONTREAL, CANADA
March 24, 2003
DATE OF REVISION:
CONTROL# 098128
June 14, 2005
THIS COMPLETE PRESCRIBING INFORMATION IS THE EXCLUSIVE PROPERTY OF
WYETH CANADA AND CANNOT BE REFERENCED, PUBLISHED OR COPIED WITHOUT
THE WRITTEN APPROVAL OF WYETH CANADA.
- 1 -
COMPLETE PRESCRIBING INFORMATION
Pr
NOVANTRONE
®
Mitoxantrone for Injection Concentrate USP
Intravenous Infusion
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
STERILE
CAUTION
NOVANTRONE 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 AT FREQUENT
INTERVALS PRIOR, DURING AND POST THERAPY. CARDIAC MONITORING IS
ADVISED IN THOSE PATIENTS WHO HAVE RECEIVED PRIOR ANTHRACYCLINES,
PRIOR MEDIASTINAL RADIOTHERAPY OR WITH PRE-EXISTING CARDIAC DISEASE.
ACTION AND CLINICAL PHARMACOLOGY
Although its mechanism of action has not been determined, mitoxantrone
is a DNA-reactive
agent. It induces nuclear aberrations with chromosome scattering in
cell cultures (human colon
carcinoma line) and is a potent inhibitor of RNA and DNA synthesis.
Compared on an
equimolar basis, mitoxantrone is seven times more potent than
doxorubicin in inhibiting the
uptake of
3
H-uridine and four times more potent in inhibiting the uptake of
3
H-thymidine by
mouse lymphoma L5178Y cells _in vitro_.
Mitoxantrone inhibits DNA-topoisomerase II, an essential nuclear
enzyme modulating DNA
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topology during multiple cellular processes such as DNA replication
and chromosome
segregation.
INDICATIONS AND CLINICAL USE
NOVANTRONE (mitoxantrone hydrochloride) is indicated for chemotherapy
in patients with
metastatic carcinoma of the breast. It is also indicated for relapsed
adult leukemia, lymphoma
patients and patients with hepatoma. NOVANTRONE in combination with
other drug(s) is
indicated in the initial therapy