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.
Busulfan is a bifunctional alkylating agent. BUSULFEX® (busulfan) Injection is intended for intravenous administration.
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.
Published Studies Related to Busulfex (Busulfan)
Clofarabine +/- fludarabine with once daily i.v. busulfan as pretransplant conditioning therapy for advanced myeloid leukemia and MDS. [2011.06]
Although a combination of i.v...
Randomized trial of two different conditioning regimens for bone marrow transplantation in thalassemia--the role of busulfan pharmacokinetics in determining outcome. [2005.11]
In total, 94 patients with homozygous beta thalassemia were randomized to two different conditioning regimens: busulfan 600 mg/m2 + cyclophosphamide 200 mg/kg or busulfan 16 mg/kg + cyclophosphamide 200 mg/kg and antilymphocyte globulin (47 in each group), for bone marrow transplantation, to see whether increased myeloablation or increased immunosuppression would reduce rejection...
Randomized trial of busulfan vs total body irradiation containing conditioning regimens for children with acute lymphoblastic leukemia: a Pediatric Blood and Marrow Transplant Consortium study. [2003.09]
Conditioning regimens for children with ALL have generally included total body irradiation (TBI), which may result in significant sequelae. The primary aim of this study was to evaluate the outcome for children with ALL undergoing allogeneic stem cell transplant (SCT) with either busulfan (Bu) or TBI regimens...
Busulfan plus cyclophosphamide compared with total-body irradiation plus cyclophosphamide before marrow transplantation for myeloid leukemia: long-term follow-up of 4 randomized studies. [2001.12.15]
In the early 1990s, 4 randomized studies compared conditioning regimens before transplantation for leukemia with either cyclophosphamide (CY) and total-body irradiation (TBI), or busulfan (Bu) and CY. This study analyzed the long-term outcomes for 316 patients with chronic myeloid leukemia (CML) and 172 patients with acute myeloid leukemia (AML) who participated in these 4 trials, now with a mean follow-up of more than 7 years...
Increased risk of chronic graft-versus-host disease, obstructive bronchiolitis, and alopecia with busulfan versus total body irradiation: long-term results of a randomized trial in allogeneic marrow recipients with leukemia. Nordic Bone Marrow Transplantation Group. [1999.04.01]
Leukemic patients receiving marrow from HLA-identical sibling donors were randomized to treatment with either busulfan 16 mg/kg (n = 88) or total body irradiation ([TBI] n = 79) in addition to cyclophosphamide 120 mg/kg. The patients were observed for a period of 5 to 9 years... In patients with chronic myeloid leukemia (CML) in first chronic phase, 7-year LFS was 72% and 83% in the two groups, respectively.
Clinical Trials Related to Busulfex (Busulfan)
Once Daily Targeted Intravenous (IV) Busulfex as Part of Reduced-toxicity Conditioning for Patients With Refractory Lymphomas Undergoing Allogeneic Transplantation [Recruiting]
This is a phase II study of allogeneic hematopoietic progenitor cell transplantation (HPCT)
followed reduced toxicity conditioning with once daily intravenous Busulfex and fludarabine
in patients with relapsed/chemotherapy refractory Hodgkin's and non-Hodgkin's lymphomas.
UARK 2003-25: A Study of Intravenous (IV) Busulfan (Busulfex®) in Multiple Myeloma Patients [Terminated]
The purpose of this study is to find out if patients with high risk disease because of age
or kidney status can be treated more safely with a drug called Busulfex® followed by
autologous transplant compared to treatment with the standard drug called melphalan, which
has been shown to be quite difficult to tolerate in patients with poor kidney function and
patients over the age of 65 when given in high doses.
Evaluation of Plasmatic Levels of Busulfan in Patients Undergoing Hematopoietic Stem Cell Transplantation [Recruiting]
Fludarabine/Clofarabine/Busulfan Combined With SAHA in Acute Leukemia [Recruiting]
The goal of this clinical research study is to evaluate the safety of combining vorinostat
(also called SAHA) with fludarabine, clofarabine, and busulfan.
Gemcitabine/Clofarabine/Busulfan and Allogeneic Transplantation for Aggressive Lymphomas [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of
gemcitabine (out of 6 possible doses) that can be given in combination with busulfan and
clofarabine before an allogeneic stem cell transplant. Researchers also want to learn if
this combination can help to control lymphoma. The safety of this treatment will also be
Busulfan is designed to bind to DNA (the genetic material of cells), which may cause cancer
cells to die. It is commonly used in stem cell transplants.
Clofarabine and gemcitabine are designed to block the growth of cancer cells, which may
cause the cancer cells to die.
Reports of Suspected Busulfex (Busulfan) Side Effects
Venoocclusive Liver Disease (14),
Acute Graft Versus Host Disease (13),
Chronic Graft Versus Host Disease (13),
Renal Failure (13),
Thrombotic Microangiopathy (12),
Acute Respiratory Distress Syndrome (8),
Pleural Effusion (8),
Mucosal Inflammation (8),
Cytomegalovirus Infection (8),
Graft Versus Host Disease (7), more >>
Page last updated: 2011-12-09