In this example, tubing volume is 20 mL and patient weighs 70 kg

• 70-kg patient x 0.8 mg/kg IV BUSULFEX = 56 mg every 6 hours*
• 56 mg of IV BUSULFEX is 9.3 mL of IV BUSULFEX undiluted
• Add to 10x volume (9 mL) of NS or D5W for total volume of 102 mL of IV BUSULFEX
• Infuse over 2 hours at 51 mL/hour or 0.85 mL/minute (102 mL ÷ 120 minutes = 0.85 mL/min or 51 mL/hr)

In this example, tubing volume is 20 mL and patient weighs 70 kg^†

• 10-kg child with a dose of 1.1 mg/kg = 11 mg of IV BUSULFEX
• 11 mg of IV BUSULFEX is 1.83 mL of IV BUSULFEX undiluted
• Add to 10x volume (18.3 mL) of NS or D5W for total volume of 20.13 mL of IV BUSULFEX solution
• Infuse over 2 hours at 10.06 mL/hr or 0.17 mL/minute (20.13 mL ÷ 120 minutes = 0.17 mL/min or 10.06 mL/hr)

* For obese, or severely obese, patients, see Full Prescribing Information for recommendations and calculations.

^†The effectiveness of IV BUSULFEX in the treatment of CML has not been specifically studied in pediatric patients. However, the product labeling includes information about available dosage and safety information based on a small, open-label, uncontrolled pharmacokinetic study in pediatric patients (n=24). In that study, all patients experienced neutropenia (absolute neutrophil count <0.5 x 10⁹/L) and thrombocytopenia (platelet transfusions or platelet count < 20,000/mm³), and 79% of patients experienced lymphopenia (absolute lymphocyte count <0.1 x 10⁹/L). Four patients died during the trial.

For additional information, please see Special Populations – Pediatric section of Full Prescribing Information.

The only FDA-approved agent for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia (CML)

Important Safety Information At the recommended dosage, IV BUSULFEX^® (busulfan) produced profound myelosuppression in all patients (ie, severe granulocytopenia, thrombocytopenia, anemia, or a combination thereof). Frequent complete blood counts should be monitored during treatment and until recovery. Hepatic veno-occlusive disease was diagnosed in 5/61 patients and was fatal in 2/5 cases. Anticonvulsant prophylactic therapy should be administered prior to treatment. Caution should be exercised in patients with a history of seizure disorder or head trauma or who are receiving other potentially epileptogenic drugs. Bronchopulmonary dysplasia with pulmonary fibrosis is a rare but serious condition following chronic busulfan therapy. Women of childbearing potential should be advised to avoid becoming pregnant as busulfan may cause fetal harm.

The most common nonhematologic adverse events were nausea (92% mild or moderate, 7% severe), stomatitis (71% grade 1-2, 26% grade 3-4), and vomiting (95% mild or moderate), anorexia (64% mild or moderate, 21% severe), diarrhea (75% mild or moderate, 5% grade 3-4), insomnia (83% mild or moderate, 1% severe), and fever (78% mild or moderate, 3% life-threatening).

Please see Full Prescribing Information.