OPEN LABEL PHARMACOKINETIC BIOAVAILABILITY EVALUATION OF MYCOPHENOLATE MOFETIL

本研究的主要目的是比较 实验性静脉制剂与批准的口服制剂 免疫抑制药吗替麦考酚酯 开始口服MMF 在移植后72小时内与环孢霉素联合使用， 类固醇被证明是安全和有效的预防肾移植 拒绝，最近被批准用于该用途。 存在一定 不能给予患者口服药物的情况，例如 肾移植后立即，肝脏或胰腺移植后 移植，或在肠梗阻或严重恶心和呕吐的情况下。 因此，患有这些疾病的患者不能接受MMF， 增加被拒绝的风险。 其他免疫抑制药物，如 硫唑嘌呤、环孢菌素和类固醇可通过静脉注射 形式，并在指示时使用。 IV MMF的安全性越来越受到关注， 在我们参与的另一项研究中进行了全面分析。 那里 未见严重毒性。

The primary purpose of this study is to compare the bioavailability of an experimental intravenous formulation to the approved oral formulation of the immunosuppressive drug, mycophenolate mofetil. Oral MMF started within 72 hours after transplant in combination with cyclosporine and steroids was shown to be safe and effective at preventing renal allograft rejection and was recently approved for that use. There are certain instances in which oral medication cannot be given to a patient, such as immediately after renal transplant, after liver or pancreas transplantation, or in the case of ileus or severe nausea and vomiting. Patients with these conditions cannot therfore receive MMF and may be at increased risk of rejection. Other immunosuppressive drugs, such as azathioprine cyclosporine and steroids are available in the intravenous form and are used when indicated. The safety of IV MMF is being more completely analyzed in a separate study in which we participated. There have been no major toxicities seen.