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Busulfex Generic Name & Formulations
Legal Class
Rx
General Description
Busulfan 6mg/mL; soln for IV infusion after dilution.
Pharmacological Class
Alkylating agent.
How Supplied
Single-use vials (10mL)—8
Manufacturer
Busulfex Indications
Indications
In combination with cyclophosphamide, as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.
Busulfex Dosage and Administration
Adult
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.
Children
See full labeling.
Busulfex Contraindications
Not Applicable
Busulfex Boxed Warnings
Boxed Warning
Myelosuppression.
Busulfex Warnings/Precautions
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
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
