Busulfan (Myleran)

General information

Class/mechanism: Bifunctional alkylating agent which produces guanine-adenine intrastrand crosslinks, inducing apoptosis.
Route: IV, PO
Extravasation: irritant

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, UpToDate Lexidrug, Medscape,or the prescribing information.

Diseases for which it is used

• Acute myeloid leukemia
• Acute promyelocytic leukemia
• Chronic lymphocytic leukemia
• Chronic myeloid leukemia
• Ewing sarcoma
• Non-Hodgkin lymphoma
  • Anaplastic large cell lymphoma
  • CNS lymphoma
  • Diffuse large B-cell lymphoma
  • Mantle cell lymphoma
  • NK- and T-cell lymphoma
  • Peripheral T-cell lymphoma
  • Primary mediastinal B-cell lymphoma
• Myelodysplastic syndrome
• Neuroblastoma

Diseases for which it was used

• Multiple myeloma

Patient drug information

• Busulfan (Myleran) package insert
• Busulfan (Myleran) patient drug information (Chemocare)
• Busulfan (Myleran) patient drug information (UpToDate)

History of changes in FDA indication

• 1954-06-26: Initial FDA approval
• 2003-01-23 (oldest label available at Drugs @ FDA): indicated for the palliative treatment of chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia. (No supporting studies are cited)

History of changes in EMA indication

• 2003-07-09: EURD

History of changes in PMDA indication

• 2020-03-25: New indication and a new dosage for the conditioning treatment of malignant lymphoma in patients prior to autologous hematopoietic stem-cell transplantation.

Also known as

• Brand names: Busilvex, Busulfex, Myleran