Busulfex

Busulfex

busulfan

Manufacturer:

Otsuka

Marketer:

Otsuka
Concise Prescribing Info
Contents
Busulfan
Indications/Uses
In combination w/ cyclophosphamide as conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.
Dosage/Direction for Use
Premedicate w/ anticonvulsants (eg, benzodiazepines, phenytoin, valproic acid or levetiracetam) 12 hr prior to 24 hr after the last high dose of Busulfex. Administer antiemetics prior to 1st dose & continue on a fixed schedule. IV Patients >12 kg 0.8 mg/kg (ideal body wt or actual body wt, whichever is lower) via central venous catheter as a 2-hr infusion every 6 hr for 4 consecutive days for a total of 16 doses (day 4, 5, 6, & 7); cyclophosphamide 60 mg/kg IV as 1-hr infusion on each of 2 days beginning no sooner than 6 hr following the 16th dose of Busulfex (day 2 & 3); administer hematopoietic progenitor cells on day 0.
Contraindications
Special Precautions
Prolonged myelosuppression, severe granulocytopenia, thrombocytopenia, anemia, or any combination may develop. High-dose oral busulfan may cause seizure; patients w/ history of seizure disorder or head trauma or who are receiving other potentially epileptogenic drugs. High AUC values may be associated w/ increased risk of developing hepatic veno-occlusive disease (HVOD). Cardiac tamponade in ped patients w/ thalassemia who received high doses. Bronchopulmonary dysplasia w/ pulmonary fibrosis. Cytologic abnormalities characterized by giant, hyperchromatic nuclei in lymph nodes, pancreas, thyroid, adrenal glands, liver, lungs & bone marrow. Monitor CBCs, including WBC differentials & quantitative platelet counts daily during treatment & until engraftment is demonstrated. Monitor for signs of local or systemic infection or bleeding; serum transaminases, alkaline phosphatase & bilirubin daily. Females & males of reproductive potential should use effective contraception during & after treatment. Pregnant women should be advised of the potential risk to the fetus. Discontinue breastfeeding during treatment. Childn.
Adverse Reactions
Myelosuppression, seizures, HVOD, embryo-fetal toxicity, cardiac tamponade, bronchopulmonary dysplasia, cellular dysplasia.
Drug Interactions
Decreased clearance w/ itraconazole, metronidazole, deferasirox, acetaminophen. Increased clearance w/ phenytoin.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01AB01 - busulfan ; Belongs to the class of alkylating agents, alkyl sulfonates. Used in the treatment of cancer.
Presentation/Packing
Form
Busulfex inj 6 mg/mL
Packing/Price
10 mL x 8 × 1's
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