Generic Name and Formulations:
Busulfan 6mg/mL; soln for IV infusion after dilution.
Otsuka America Pharmaceutical, Inc.
Indications for BUSULFEX:
In combination with cyclophosphamide, as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.
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.
See full labeling.
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.
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.
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.
Single-use vials (10mL)—8