2013年8月24日讯 --安斯泰来（Astellas）8月23日宣布，在美国推出Astagraf XL（他克莫司缓释胶囊，tacrolimus extended release capsules），该药与霉酚酸酯（MMF）及皮质类醇联用、结合或无巴利昔单抗（basiliximab）诱导，用于预防成人肾移植受者中的器官排斥。

在美国，Astagraf XL是首个每日一次的他克莫司制剂，于2013年7月19日获FDA批准，该药作为免疫抑制组合方案中的核心组成部分，为肾移植受者预防器官排斥反应提供了一个很有潜力的疗法。

在2007年，他克莫司缓释胶囊在欧洲获批以商品名Advagraf销售；2008年，该药在日本获批以商品名Graceptor销售。总体而言，他克莫司缓释胶囊已获得了全球73个国家的监管批准，每年经该药治疗的患者数超过14万人。

英文原文：Astellas' Astagraf XL Launched in U.S.

August 23, 2013 Astellas Pharma US, Inc. (“Astellas”), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced today that ASTAGRAF XL (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant used with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction, is now available in U.S. pharmacies.

“The availability of ASTAGRAF XL marks a significant moment for the transplantation community, giving new adult kidney transplant recipients an additional option in their immunosuppressant care,” said James Robinson, President, Astellas Pharma US, Inc. “Astellas has long been a leader in the field of transplant immunology, and we are proud to continue to advance care for transplant recipients.”

ASTAGRAF XL is the first once-daily oral tacrolimus formulation available in the U.S. for the prophylaxis of organ rejection in adult kidney transplant patients. ASTAGRAF XL was approved by the U.S. Food and Drug Administration (FDA) on July 19, 2013. In total, tacrolimus extended-release capsules have been approved for use in 73 countries.

The recommended starting dose of ASTAGRAF XL with basiliximab induction is 0.15 mg/kg once-daily. The recommended starting dose of ASTAGRAF XL without basiliximab induction is 0.1 mg/kg once-daily (pre-operative) and 0.2 mg/kg once-daily (post-operative). It is available in 0.5 mg, 1 mg and 5 mg capsules.

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