Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
busulfan (UNII: G1LN9045DK) (busulfan - UNII:G1LN9045DK)
Athenex Pharmaceutical Division, LLC.
INTRAVENOUS
PRESCRIPTION DRUG
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 is contraindicated in patients with a history of hypersensitivity to any of its components. Risk Summary Busulfan can cause fetal harm when administered to a pregnant woman based on animal data. Busulfan was teratogenic in mice, rats, and rabbits following administration during organogenesis. The solvent, DMA, may also cause fetal harm when administered to a pregnant woman. In rats, DMA doses of approximately 40% of the daily dose of DMA in the busulfan dose on a mg/m2 basis given during organogenesis caused significant developmental anomalies (see Data) . There are no available human data informing the drug-associated risk. Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated populations are unknown. However, the back
Busulfan Injection is supplied as follows: Busulfan injection is packaged as a sterile solution in 10 mL single-dose clear glass vials. Each vial contains 60 mg of busulfan at a concentration of 6 mg per mL for intravenous use. Storage Conditions Store unopened vials of busulfan refrigerated between 2° and 8°C (36° and 46°F). Busulfan diluted in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP is stable at room temperature (25°C) for up to 8 hours but the infusion must be completed within that time. Busulfan diluted in 0.9% Sodium Chloride Injection, USP is stable at refrigerated conditions (2°C to 8°C) for up to 12 hours but the infusion must be completed within that time. Busulfan is a cytotoxic drug. Follow applicable special handling and disposal procedures1 . Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.
Abbreviated New Drug Application
BUSULFAN- BUSULFAN INJECTION, SOLUTION, CONCENTRATE ATHENEX PHARMACEUTICAL DIVISION, LLC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BUSULFAN INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUSULFAN INJECTION. BUSULFAN INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1999 WARNING: MYELOSUPPRESSION _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ CAUSES SEVERE AND PROLONGED MYELOSUPPRESSION. (5.1) HEMATOPOIETIC PROGENITOR CELL TRANSPLANTATION IS REQUIRED TO PREVENT POTENTIALLY FATAL COMPLICATIONS OF THE PROLONGED MYELOSUPPRESSION. (5.1) INDICATIONS AND USAGE Busulfan 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) (1) DOSAGE AND ADMINISTRATION Pre-medicate with anticonvulsants (e.g. benzodiazepines, phenytoin, valproic acid or levetiracetam) and antiemetic (2.1, 5.2) Dilute and administer as intravenous infusion. Do not administer as intravenous push or bolus (2.1, 2.3) Recommended adult dose: 0.8 mg per kg of ideal body weight or actual body weight, whichever is lower, administered intravenously via a central venous catheter as a two-hour infusion every six hours for four consecutive days for a total of 16 doses (2.1) DOSAGE FORMS AND STRENGTHS Busulfan Injection: 60 mg per 10 mL (6 mg per mL) single-dose vial (3) CONTRAINDICATIONS Busulfan is contraindicated in patients with a history of hypersensitivity to any of its components (4) WARNINGS AND PRECAUTIONS Seizures: Initiate anticonvulsant prophylactic therapy prior to treatment with busulfan. Monitor patients with history of seizure disorder, head trauma or receiving epileptogenic drugs (5.2) 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 (5.3) Embryo-fetal To Przeczytaj cały dokument