Država: Malezija
Jezik: angleščina
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BUSULFAN
SMART MEDICINE SDN. BHD.
BUSULFAN
10ml mL; 10 ml mL
Patheon Manufacturing Services LLC
Not Applicable Preberite celoten dokument
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 Preberite celoten dokument