BUSULFEX® INJECTION 60 mgvial

Страна: Сингапур

Язык: английский

Источник: HSA (Health Sciences Authority)

Активный ингредиент:

BUSULFAN

Доступна с:

STEWARD CROSS PTE LTD

код АТС:

L01AB01

дозировка:

60 mg/vial

Фармацевтическая форма:

INJECTION, SOLUTION, CONCENTRATE

состав:

BUSULFAN 60 mg/vial

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

Prescription Only

Производитель:

Baxter Oncology GmbH

Статус Авторизация:

ACTIVE

Дата Авторизация:

2007-04-30

тонкая брошюра

1 
BUSULFEX
® 
(BUSULFAN) INJECTION 
Caution: Must be diluted prior to use. 
R
X
ONLY 
WARNING
BUSULFEX
®
(busulfan) Injection is a potent cytotoxic drug
that causes profound  myelosuppression at 
the recommended dosage. It should be
administered under the supervision of a qualified physician 
who is experienced
in allogeneic hematopoietic stem cell transplantation, the use
of cancer 
chemotherapeutic drugs and 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. SEE “WARNINGS” SECTION FOR
INFORMATION REGARDING 
BUSULFAN-INDUCED PANCYTOPENIA IN HUMANS.
DESCRIPTION 
Busulfan is a bifunctional alkylating agent known
chemically as 1,4-butanediol, dimethanesulfonate. 
BUSULFEX® (busulfan) Injection is intended for intravenous administration.  It is supplied
as a clear, 
colorless, sterile, solution in 10 mL single use vials.  Each vial of BUSULFEX contains 60 mg (6 
mg/mL) of busulfan, the active ingredient, a white crystalline powder with a molecular formula of 
CH
3
SO
2
O(CH
2
)
4
OSO
2
CH
3
 and a molecular weight of 246 g/mole. Busulfan
is dissolved in 
N,Ndimethylacetamide (DMA), 3.3 mL and Polyethylene
Glycol 400, NF 6.7 mL. The solubility of 
busulfan in water is 0.1 g/L and the pH of BUSULFEX diluted
to approximately 0.5 mg/mL busulfan in 
0.9% Sodium Chloride Injection, USP or 5%
Dextrose Injection, USP as recommended for infusion 
reflects the pH of the diluent used and ranges from 3.4 to 3.9. 
BUSULFEX is intended for dilution with 0.9% Sodium Chloride
Injection, USP or 5% Dextrose 
Injection, USP prior to intravenous infusion. 
CLINICAL PHARMACOLOGY 
_MECHANISM OF ACTION: _
Busulfan is a bifunctional alkylating agent in which two
labile methanesulfonate gr

Характеристики продукта

BUSULFEX
®
(BUSULFAN) INJECTION
Caution: Must be diluted prior to use.
RX
ONLY
WARNING:
MYELOSUPPRESSION
BUSULFEX® (BUSULFAN) INJECTION CAUSES SEVERE AND PROLONGED
MYELOSUPPRESSION AT THE RECOMMENDED DOSAGE.
HEMATOPOIETIC PROGENITOR CELL TRANSPLANTATION IS REQUIRED TO PREVENT
POTENTIALLY FATAL COMPLICATIONS OF THE
PROLONGED MYELOSUPPRESSION. [SEE _WARNINGS AND PRECAUTIONS (5.1)_].
1 INDICATIONS AND USAGE
BUSULFEX is indicated for use in combination with cyclophosphamide as
a conditioning regimen prior to allogeneic
hematopoietic progenitor cell transplantation for chronic myelogenous
leukemia.
2 DOSAGE AND ADMINISTRATION
2.1 INITIAL DOSING INFORMATION

Administer BUSULFEX in combination with cyclophosphamide as a
conditioning regimen prior to bone marrow
or peripheral blood progenitor cell replacement. For adult patients,
the recommended doses (BuCY2 regimen) are:
-BUSULFEX 0.8 mg/kg (ideal body weight or actual body weight,
whichever is lower) intravenously via a central
venous catheter as a two-hour infusion every six hours for four
consecutive days for a total of 16 doses (Days -
7, -6, -5 and -4).
-Cyclophosphamide 60 mg/kg intravenously as a one-hour infusion on
each of two days beginning no sooner than
six hours following the 16
th
dose of BUSULFEX (Days -3 and -2).
-Administer hematopoietic progenitor cells on Day 0.

Premedicate patients with anticonvulsants (e.g., benzodiazepines,
phenytoin, valproic acid or levetiracetam) to
prevent seizures reported with the use of high dose BUSULFEX.
Administer anticonvulsants 12 hours prior to
BUSULFEX to 24 hours after the last dose of BUSULFEX. _[see Warnings
and_ _Precautions ( 5.2)]_

Administer antiemetics prior to the first dose of BUSULFEX and
continue on a fixed schedule through
BUSULFEX administration.

BUSULFEX clearance is best predicted when the BUSULFEX dose is
administered based on adjusted ideal body
weight. Dosing BUSULFEX based on actual body weight, ideal body weight
or other factors can produce
significant differences in BUSULFEX clea