Antineoplastic AgentsBusulfex (busulfan) Injection
Manufacturer: Orphan Medical, Inc.
Drug Approval Classification: Supplemental NDA (approval date: 1/13/03)
Pharmacokinetics: This supplemental drug approval provides for the addition of pharmacokinetic data from an open-label, uncontrolled, pharmacokinetics study of busulfan in 24 pediatric patients receiving busulfan as part of a conditioning regimen administered prior to hematopoietic progenitor cell transplantation for a variety of malignant hematologic (n = 15) or nonmalignant (n = 9) diseases. Patients ranged in age from 5 months to 16 years (median 3 years).
The Table includes the recommended dosing regimen in pediatric patients.Busulfex Dosing
|Patient's Actual Body Weight||Busulfex Dose|
|≤ 12 kg||1.1 mg/kg|
|> 12 kg||0.8 mg/kg|
The target busulfan exposure AUC is between 900 and 1350 microM/min for the first dose. Therapeutic drug monitoring is recommended for subsequent doses to reach a target AUC of 1125 microM/min . Busulfex labeling describes formula and instructions for therapeutic drug monitoring.
Medscape Pharmacists. 2003;4(1) © 2003 Medscape
Cite this: February 2003 - Medscape - Feb 20, 2003.