Concise Prescribing Info
In combination w/ cyclophosphamide as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in adults when the combination is considered the best available option. In combination w/ fludarabine as conditioning treatment prior to haematopoietic progenitor cell transplantation in adults who are candidates for reduced-intensity conditioning regimen.
Dosage/Direction for Use
IV infusion Via central venous catheter. Dilute to final conc of approx 0.5 mg/mL prior to administration. In combination w/ cyclophosphamide Adult including the elderly Busulfex 0.8 mg/kg as a 2-hr infusion every 6 hr over 4 consecutive days. Total of 16 doses. Followed by cyclophosphamide 60 mg/kg/day over 2 days initiated for at least 24 hr following the 16th dose of Busulfex. In combination w/ fludarabine Adult including the elderly Fludarabine administered as single daily 1-hr infusion at 30 mg/m2 for 5 consecutive days or 40 mg/m2 for 4 consecutive days. Administer Busulfex at 3.2 mg/kg as single daily 3-hr infusion immediately after fludarabine for 2 or 3 consecutive days.
Special Precautions
Do not administer by rapid IV, bolus or peripheral inj. Monitor CBC, including differential WBC & platelet counts, during treatment & until recovery is achieved. Regularly monitor serum transaminase, alkaline phosphatase & bilirubin 28 days following transplant for early detection of hepatotoxicity. Risk of hepatic veno-occlusive disease. Caution when using paracetamol prior to (<72 hr) or concurrently w/ Busulfex. Regularly monitor cardiac function. Might induce pulmonary toxicity. Consider periodic monitoring of renal function during therapy. Risk of seizures w/ high-dose busulfan treatment. Patients should receive adequate anticonvulsant prophylaxis. Increased risk of 2nd malignancy. Reports of thrombotic microangiopathy w/ high-dose conditioning regimens. Caution in patients w/ renal or hepatic impairment. Consider dosing based on adjusted ideal body wt in obese patients. Can impair fertility. Women of childbearing potential should use effective contraception during & up to 6 mth after treatment. Discontinue breast-feeding during treatment.
Adverse Reactions
In combination w/ cyclophosphamide: Fever, headache, abdominal pain, asthenia, chills, pain, allergic reaction, edema general, inflammation at inj site, chest pain; tachycardia, thrombosis, HTN, vasodilation; nausea, stomatitis (mucositis), vomiting, anorexia, diarrhea, dyspepsia, constipation, rectal disorder; hypomagnesemia, hypokalemia, hyperglycemia, hypocalcemia, hyperbilirubinemia, edema, SGPT elevation, hypophosphatemia; insomnia, anxiety, dizziness, depression; rhinitis, cough, lung disorder, pharyngitis, epistaxis, dyspnea; rash, pruritus. In combination w/ fludarabine: Viral infection, CMV reactivation, EBV reactivation, bacterial infection; hypoalbuminaemia, electrolyte disturbance, hyperglycaemia; nausea, vomiting, diarrhoea, stomatitis; veno-occlusive liver disease; haemorrhagic cystitis; mucositis; increased transaminases, bilirubin, alkaline phosphatases. Invasive fungal infection, pulmonary infection; headache, nervous system disorders (not elsewhere classified); HTN; pulmonary haemorrhage; rash; renal disorder; elevated creatinine.
Drug Interactions
Decreased clearance w/ itraconazole, metronidazole, paracetamol. Increased plasma levels w/ ketobemidone (analgesic). Reports of increased clearance w/ phenytoin. Increased exposure w/ deferasirox.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01AB01 - busulfan ; Belongs to the class of alkylating agents, alkyl sulfonates. Used in the treatment of cancer.
Busulfex conc for soln for infusion 6 mg/mL
10 mL x 8 × 1's
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