• Leukemias, lymphomas, and other hematologic cancers

Busulfex Generic Name & Formulations

General Description

Busulfan 6mg/mL; soln for IV infusion after dilution.

Pharmacological Class

Alkylating agent.

How Supplied

Single-use vials (10mL)—8

Busulfex Indications


In combination with cyclophosphamide, as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.

Busulfex Dosage and Administration


See full labeling. Premedicate with anticonvulsants and antiemetics. Give by IV infusion over 2 hours. 0.8mg/kg of ideal body weight or actual body weight, whichever is lower, every 6 hours for 4 days for total of 16 doses (on Days -7, -6, -5, and -4). Give cyclophosphamide after the 16th dose of busulfan (Days -3 and -2). Give hematopoietic progenitor cells on Day 0. Obese: base dose on adjusted ideal body weight.


See full labeling.

Busulfex Contraindications

Not Applicable

Busulfex Boxed Warnings

Boxed Warning


Busulfex Warnings/Precautions


Risk of severe and prolonged myelosuppression; requires hematopoietic progenitor cell transplantation. Seizure disorder. Head trauma. Monitor CBCs with differential, platelet counts, liver enzymes, bilirubin during treatment and until recovery. Monitor for infection and bleeding. Risk of ovarian suppression and amenorrhea in premenopausal women. Embryo-fetal toxicity. Pregnancy; use effective contraception during and for 6 months (females) or 3 months (males) after treatment. Nursing mothers: not recommended.

Busulfex Pharmacokinetics

See Literature

Busulfex Interactions


Potentiated by itraconazole, metronidazole, deferasirox, acetaminophen. Discontinue iron chelating agents well in advance prior to Busulfex therapy. May be antagonized by phenytoin. Caution with potentially epileptogenic drugs.

Busulfex Adverse Reactions

Adverse Reactions

Myelosuppression, nausea, stomatitis, vomiting, anorexia, diarrhea, insomnia, fever, hypomagnesemia, abdominal pain, anxiety, headache, hyperglycemia, hypokalemia; seizures (with higher doses), hepatic veno-occlusive disease (with high AUC), cardiac tamponade (in pediatric patients with thalassemia), cellular dysplasia; rare: bronchopulmonary dysplasia with pulmonary fibrosis.

Busulfex Clinical Trials

See Literature

Busulfex Note

Not Applicable

Busulfex Patient Counseling

See Literature