BUSULFAN FOR INJECTION SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

BUSULFAN

Disponibil de la:

AURO PHARMA INC

Codul ATC:

L01AB01

INN (nume internaţional):

BUSULFAN

Dozare:

60MG

Forma farmaceutică:

SOLUTION

Compoziție:

BUSULFAN 60MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTINEOPLASTIC AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0103273002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2021-10-14

Caracteristicilor produsului

Page 1 of 31
PRODUCT MONOGRAPH
PR
BUSULFAN FOR INJECTION
SOLUTION, 60 MG / 10 ML (6 MG / ML)
MUST BE DILUTED PRIOR TO USE.
ANTINEOPLASTIC
Auro Pharma Inc.
DATE OF PREPARATION:
3700 Steeles Avenue West, Suite # 402
October 8, 2021.
Woodbridge, Ontario, L4L 8K8,
Canada
CONTROL NUMBER: 233688
Page 2 of 31
PRODUCT MONOGRAPH
NAME OF DRUG
PR
BUSULFAN FOR INJECTION
60 mg / 10 mL (6 mg / mL)
BUSULFAN FOR INJECTION IS A POTENT CYTOTOXIC DRUG THAT RESULTS IN
PROFOUND MYELOSUPPRESSION AT THE RECOMMENDED DOSAGE. IT SHOULD
BE ADMINISTERED UNDER THE SUPERVISION OF A QUALIFIED PHYSICIAN
WHO IS EXPERIENCED IN THE USE OF CANCER CHEMOTHERAPEUTIC AGENTS
AND IN THE MANAGEMENT OF PATIENTS WITH SEVERE PANCYTOPENIA.
APPROPRIATE MANAGEMENT OF THERAPY AND COMPLICATIONS IS ONLY
POSSIBLE WHEN ADEQUATE DIAGNOSTIC AND TREATMENT FACILITIES ARE
READILY AVAILABLE.
ACTIONS AND CLINICAL PHARMACOLOGY
Busulfan is a potent cytotoxic
agent and a bifunctional
alkylating
agent. In aqueous media,
release of the methanesulfonate
group produces carbonium
ions, which can alkylate DNA,
thought to be an important biological mechanism for its cytotoxic
effect.
Current literature suggests that high AUC values (>1,500 mcMol•min)
may be associated with
an
increased risk of developing hepatic veno-occlusive disease and/or
seizures.
Mean C
max
, AUC, T
1/2
and plasma
clearance are provided
below
for oral
busulfan
and IV
busulfan (See PHARMACOLOGY).
PARAMETER
ORAL BUSULFAN
BUSULFAN IV
C
max
(ng/mL) (range) (CV%)
870 (30%)
1,167 (12%)
AUC (mcMol•min) (CV%)
1,396 (24%)
1,156 (14%)
T
1/2
(hr) (CV%)
3.55 (33%)
3.11 (10%)
Plasma Clearance (mL/min) (CV%)
195 (27%)
182 (16%)
Intravenous
busulfan had a more consistent pharmacokinetic
profile than oral busulfan
among
patients.
Busulfan
achieves concentrations
in
the cerebrospinal
fluid
approximately
equal
to those in
plasma. Irreversible binding
to plasma elements, primarily
albumin,
has been estimated to be
32.4 + 2.2%, which is consistent with the reactive electrophilic
properties of this alkylator.
Page 3 of 31
Busul