Jane S. Ricciuti, RPh, MS


February 19, 2003

In This Article

Antineoplastic Agents

(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.

Busulfex (busulfan) Injection Labeling

Busulfex (busulfan) Injection


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