IV BUSULFEX was approved by the U.S. Food and Drug Administration (FDA) on February 4, 1999, as a conditioning agent, in combination with cyclophosphamide, prior to allogeneic hematopoietic stem cell transplantation (HSCT, also referred to as blood or marrow transplantation) in patients with chronic myelogenous leukemia (CML). IV BUSULFEX is the only drug that is FDA-approved for use as a conditioning agent in allogeneic hematopoietic stem cell transplantation in CML.

IV BUSULFEX is an intravenous form of oral busulfan, a chemotherapeutic agent commonly used as part of a conditioning regimen in the transplant setting. One of the major issues with the oral formulation has been the inability to consistently provide dose assurance and dosimetry to patients.¹ Additionally, oral busulfan is only available as 2-mg tablets,² in which a 70-kg adult would need to ingest approximately 560 tablets over four days. Oral administration may also be complicated by emesis (vomiting).¹

IV BUSULFEX is 100% bioavailable, so the entire amount given is available in the systemic circulation immediately after infusion. Because it is administered intravenously, each dose of IV BUSULFEX can be precisely administered and controlled.¹ With IV BUSULFEX, there is also no drug loss through emesis.

1. Andersson BS, Kashyap A, Gian V, et al. Conditioning therapy with intravenous busulfan and cyclophosphamide (IV BuCy2) for hematologic malignancies prior to allogeneic stem cell transplantation: a phase II study. Biol Blood Marrow Transplant. 2002;8:145-154.
2. Myleran^® (busulfan) Tablets prescribing information. GlaxoSmithKline. 2004.



Myleran^® is a registered trademark of GlaxoSmithKline.

The only FDA-approved agent for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia (CML)

Important Safety Information At the recommended dosage, IV BUSULFEX^® (busulfan) produced profound myelosuppression in all patients (ie, severe granulocytopenia, thrombocytopenia, anemia, or a combination thereof). Frequent complete blood counts should be monitored during treatment and until recovery. Hepatic veno-occlusive disease was diagnosed in 5/61 patients and was fatal in 2/5 cases. Anticonvulsant prophylactic therapy should be administered prior to treatment. Caution should be exercised in patients with a history of seizure disorder or head trauma or who are receiving other potentially epileptogenic drugs. Bronchopulmonary dysplasia with pulmonary fibrosis is a rare but serious condition following chronic busulfan therapy. Women of childbearing potential should be advised to avoid becoming pregnant as busulfan may cause fetal harm.

The most common nonhematologic adverse events were nausea (92% mild or moderate, 7% severe), stomatitis (71% grade 1-2, 26% grade 3-4), and vomiting (95% mild or moderate), anorexia (64% mild or moderate, 21% severe), diarrhea (75% mild or moderate, 5% grade 3-4), insomnia (83% mild or moderate, 1% severe), and fever (78% mild or moderate, 3% life-threatening).

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