Valsts: Singapūra
Valoda: angļu
Klimata pārmaiņas: HSA (Health Sciences Authority)
BUSULFAN
STEWARD CROSS PTE LTD
L01AB01
60 mg/vial
INJECTION, SOLUTION, CONCENTRATE
BUSULFAN 60 mg/vial
INTRAVENOUS
Prescription Only
Baxter Oncology GmbH
ACTIVE
2007-04-30
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 Izlasiet visu dokumentu
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 Izlasiet visu dokumentu