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PrecautionsAn administration set with minimal residual hold-up volume (2–5 cc) should be used for product administration. As with other cytotoxic compounds, caution should be exercised in handling and preparing the solution of IV BUSULFEX. Skin reactions may occur with accidental exposure. The use of gloves is recommended. If IV BUSULFEX or diluted IV BUSULFEX solution contacts the skin or mucosa, wash the skin or mucosa thoroughly with water. IV BUSULFEX is a clear, colorless solution. Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever the solution and container permit. If particulate matter is seen in the IV BUSULFEX vial the drug should not be used. Preparation and AdministrationIV BUSULFEX must be diluted prior to use with either 0.9% Sodium Chloride Injection, USP (normal saline), or 5% Dextrose Injection, USP (D5W). The diluent quantity should be 10 times the volume of IV BUSULFEX, so that the final concentration of busulfan is approximately 0.5 mg/mL. Calculation of the dose for a 70-kg patient would be performed as follows: (70-kg patient) x (0.8 mg/kg) ÷ (6 mg/mL) = 9.3 mL IV BUSULFEX (56 mg total dose) To prepare the final solution for infusion, add 9.3 mL of IV BUSULFEX to 93 mL of diluent (normal saline or D5W) as calculated below: (9.3 mL IV BUSULFEX) x (10) = 93 mL of either diluent plus the 9.3 mL of IV BUSULFEX to yield a final concentration of busulfan of 0.54 mg/mL (9.3 mL x 6 mg/mL ÷ 102.3 mL = 0.54 mg/mL) All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood while wearing gloves and protective clothing. DO NOT USE POLYCARBONATE SYRINGES WITH IV BUSULFEX. Infusion pumps should be used to administer the diluted IV BUSULFEX solution. Set the flow rate of the pump to deliver the entire prescribed IV BUSULFEX dose over 2 hours. Prior to and following each infusion, flush the indwelling catheter line with approximately 5 mL of 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP. DO NOT INFUSE CONCOMITANTLY WITH ANOTHER INTRAVENOUS SOLUTION OF UNKNOWN COMPATIBILITY. WARNING: RAPID INFUSION OF IV BUSULFEX HAS NOT BEEN TESTED AND IS NOT RECOMMENDED. Please see 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)
WARNING: BUSULFEX® (busulfan) Injection is a potent cytotoxic drug that causes profound myelosuppression at the recommended dosage. It should be administered under the supervision of a qualified physician who is experienced in allogeneic hematopoietic stem cell transplantation, the use of cancer chemotherapeutic drugs, and the management of patients with severe pancytopenia. Appropriate management of therapy and complications is only possible when adequate diagnostic and treatment facilities are readily available. SEE "WARNINGS" SECTION OF FULL PRESCRIBING INFORMATION FOR INFORMATION REGARDING BUSULFAN-INDUCED PANCYTOPENIA IN HUMANS.
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).
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© 2010 Otsuka America Pharmaceutical, Inc. 0609W-0204 04/09 BUSULFEX® is a registered trademark of Otsuka Pharmaceutical Co., Ltd. |
