NORTHBROOK, Ill. August 22, 2013 – Astellas Pharma US, Inc. (“Astellas”), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced today that ASTAGRAF XLTM (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.