BUSULFEX SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

BUSULFAN

متاح من:

OTSUKA PHARMACEUTICAL CO LTD

ATC رمز:

L01AB01

INN (الاسم الدولي):

BUSULFAN

جرعة:

60MG

الشكل الصيدلاني:

SOLUTION

تركيب:

BUSULFAN 60MG

طريقة التعاطي:

INTRAVENOUS

الوحدات في الحزمة:

8X10ML

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

ANTINEOPLASTIC AGENTS

ملخص المنتج:

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

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2020-09-01

خصائص المنتج

PRODUCT MONOGRAPH
PR
BUSULFEX
®
(BUSULFAN)
6 MG/ML
INJECTION
ANTINEOPLASTIC
Otsuka Pharmaceutical Co., Ltd.
DATE OF REVISION:
Tokyo, 101-8535 Japan
March 10, 2017
Distributed and Marketed by:
CONTROL # 200963
Otsuka Canada Pharmaceutical Inc.
Saint-Laurent, Quebec H4S 2C9
2
PRODUCT
MONOGRAPH
NAME OF DRUG
Pr
BUSULFEX


(Busulfan) Injection 6
mg/mL
BUSULFEX
(BUSULFAN)
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 PHARMACOL
OGY
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 μMol•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
BUSULFEX (busulfan) (See PHARMACOLOGY).
PARAMETER
ORAL BUSULFAN
BUSULFEX IV
C
max
(ng/mL) (range) (CV%)
870 (30%)
1,167 (12%)
AUC (μMol•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%)
3
Intravenous BUSULFEX 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.
Busulfan
is
predominately
me