No filtration required No need to break glass top 24-month shelf life

IV BUSULFEX offers controlled myeloablation, allowing HSCT specialists to target dosing appropriately for each individual patient.¹

How supplied

IV BUSULFEX is supplied as a clear, colorless, sterile solution in 10-mL single-use glass vials each containing 60 mg of busulfan at a concentration of 6 mg/mL for intravenous use.
IV BUSULFEX is packaged in a tray pack of 8 vials.

The vials are made of Wheaton clear 10-mL, 13-mm, Type 1 Flint Tubing with Teflon^®-coated stoppers containing a 13-mm flip-off seal and metal crimp.

Preparation, storage, and stability

Unopened vials of IV BUSULFEX must be refrigerated at conditions between 2°-8°C (36°-46°F).

Formulation

Ordering

1. Prescribing Information for IV BUSULFEX.

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.