BUSULFAN FOR INJECTION SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

BUSULFAN

Доступна з:

EUGIA PHARMA INC.

Код атс:

L01AB01

ІПН (Міжнародна Ім'я):

BUSULFAN

Дозування:

60MG

Фармацевтична форма:

SOLUTION

Склад:

BUSULFAN 60MG

Адміністрація маршрут:

INTRAVENOUS

Одиниць в упаковці:

100

Тип рецепту:

Prescription

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2023-04-04

Характеристики продукта

Page 1 of 31
PRODUCT MONOGRAPH
PR
BUSULFAN FOR INJECTION
SOLUTION, 60 MG / 10 ML (6 MG / ML)
MUST BE DILUTED PRIOR TO USE.
Intravenous
ANTINEOPLASTIC
Eugia Pharma Inc.
DATE OF PREPARATION:
3700 Steeles Avenue West, Suite 402
April 04, 2023
Woodbridge, Ontario, L4L 8K8
Canada
CONTROL NUMBER: 271846
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.
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