Busulmax 60mg Injection

Busulfan injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. Busulfan injection is an alkylating drug indicated for: Use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia (CML)

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Boxed warning. MYELOSUPPRESSION Busulfan injection causes severe and prolonged myelosuppression at the recommended dosage. Hematopoietic progenitor cell transplantation is required to prevent potentially fatal complications of the prolonged myelosuppression. WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. Causes severe and prolonged myelosuppression. Seizures: Initiate anticonvulsant prophylactic therapy prior to treatment with Busulfan. Monitor patients with history of seizure disorder, head trauma or receiving epileptogenic drugs Hepatic Veno-Occlusive Disease (HVOD): Increased risk of developing HVOD at AUC greater than 1,500 µM - min. Monitor serum transaminases, alkaline phosphatase and bilirubin daily Embryo-fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception Cardiac tamponade has been reported in pediatric patients with thalassemia who received high doses of oral Busulfan and cyclophosphamide. Abdominal pain and vomiting preceded the tamponade in most patients Myelosuppression The most frequent serious consequence of treatment with Busulfan at the recommended dose and schedule is prolonged myelosuppression, occurring in all patients (100%). Severe granulocytopenia, thrombocytopenia, anemia, or any combination thereof may develop. Monitor complete blood counts, including white blood cell differentials, and quantitative platelet counts daily during treatment and until engraftment is demonstrated. Absolute neutrophil counts dropped below 0.5x10 9 /L at a median of 4 days post-transplant in 100% of patients treated in the Busulfan clinical trial. The absolute neutrophil count recovered at a median of 13 days following allogeneic transplantation when prophylactic filgrastim was used in the majority of patients. Thrombocytopenia (less than 25,000/mm 3 or requiring platelet transfusion) occurred at a median of 5 to 6 days in 98% of patients. Anemia (hemoglobin less than 8.0 g/dL) occurred in 69% of patients. Use antibiotic therapy and platelet and red blood cell support when medically indicated. Seizures Seizures have been reported in patients receiving high-dose oral Busulfan at doses producing plasma drug levels similar to those achieved following the recommended dosage of Busulfan. Despite prophylactic therapy with phenytoin, one seizure (1/42 patients) was reported during an autologous transplantation clinical trial of Busulfan. This episode occurred during the cyclophosphamide portion of the conditioning regimen, 36 hours after the last Busulfan dose. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following adverse reactions are discussed in more detail in other sections of the labeling: Myelosuppression Seizures Hepatic Veno-Occlusive Disease (HVOD) Embryo-fetal Toxicity Cardiac Tamponade Bronchopulmonary Dysplasia Cellular Dysplasia Most common adverse reactions (incidence >60%) were: myelosuppression, nausea, stomatitis, vomiting, anorexia, diarrhea, insomnia, fever, hypomagnesemia, abdominal pain, anxiety, headache, hyperglycemia and hypokalemia. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reaction information is primarily derived from the clinical study (N=61) of Busulfan and the data obtained for high-dose oral Busulfan conditioning in the setting of randomized, controlled trials identified through a literature review. In the Busulfan injection allogeneic stem cell transplantation clinical trial, all patients were treated with Busulfan 0.8 mg per kg as a two-hour infusion every six hours for 16 doses over four days, combined with cyclophosphamide 60 mg per kg x2 days. Ninety-three percent (93%) of evaluable patients receiving this dose of Busulfan maintained an AUC less than 1,500 µM - min for dose 9, which has generally been considered the level that minimizes the risk of HVOD. Table 1 lists the non-hematologic adverse reactions events through Bone Marrow Transplantation (BMT) Day +28 at a rate greater than or equal to 20% in patients treated with Busulfan prior to allogeneic hematopoietic cell transplantation. Table 1: Summary of the Incidence (greater than or equal to 20%) of Non-Hematologic Adverse Reactions through BMT Day +28 in Patients who Received Busulfan Prior to Allogeneic Hematopoietic Progenitor Cell Transplantation 1. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.