Drug Information



Brand Name:Busulfex Trade Name:busulfan intravenous
FDA Approved For:BUSULFEX (busulfan) Injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. Pediatric Use:The safety and efficacy of BUSULFEX in children have not been established. Busulfan clearance has been demonstrated to be higher in children than in adults. This has necessitated the development of alternative dosing regimens for oral busulfan in this population. Studies are underway to define the pharmacokinetics of BUSULFEX in children. Currently the recommended dose of BUSULFEX in children has not been defined.
Carcinogen:The intravenous administration of busulfan (48 mg/kg given as biweekly doses of 12 mg/kg, or 30% of the total BUSULFEX dose on a mg/m 2 basis) has been shown to increase the incidence of thymic and ovarian tumors in mice. Four cases of acute leukemia occurred among 19 patients who became pancytopenic in a 243 patient study incorporating busulfan as adjuvant therapy following surgical resection of bronchogenic carcinoma. Clinical appearance of leukemia was observed 5-8 years following oral busulfan treatment. Busulfan is a presumed human carcinogen.Mutagen:Busulfan is a mutagen and a clastogen. In in vitro tests it caused mutations in Salmonella typhimurium and Drosophila melanogaster. Chromosomal aberrations induced by busulfan have been reported in vivo (rats, mice, hamsters, and humans) and in vitro (rodent and human cells).
Manufacturer and/or Distributor:Orphan Medical, Inc

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