BUSULFEX INJECTION

Pays: Malaisie

Langue: anglais

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingrédients actifs:

BUSULFAN

Disponible depuis:

SMART MEDICINE SDN. BHD.

DCI (Dénomination commune internationale):

BUSULFAN

Unités en paquet:

10ml mL; 10 ml mL

Fabriqué par:

Patheon Manufacturing Services LLC

Notice patient

Not Applicable

Résumé des caractéristiques du produit

Non-Hematological Adverse Reactions 1
1 Includes all reported adverse reactions regardless of severity (toxici\
ty grades 1-4)
GVHD 3 VOD 2
TRM 1
WARNING: MYELOSUPPRESSION
BUSULFEX ® (busulfan) Injection causes severe and prolonged myelosuppression at \
the recommended
dosage. Hematopoietic progenitor cell transplantation is required to pre\
vent 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 mye\
logenous 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 administe\
red based on adjusted ideal body weight. Dosing BUSULFEX based on actual body weight, ideal body wei