Astellas Pharma US, Inc., a subsidiary of Tokyo-based Astellas Pharma Inc. has made availability of 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, in US 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 US for the prophylaxis of organ rejection in adult kidney transplant patients. Astagraf XL was approved by the US 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.
Astagraf XL capsules is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney transplant. Astagraf XL is an extended-release capsule and is not the same as tacrolimus immediate-release capsules. Your doctor should decide what medicine is right for you.
Astagraf XL is not for use with medicines called cyclosporine (Neoral, Sandimmune, Gengraf). It is not known if Astagraf XL is safe and effective when used with sirolimus (Rapamune) in people who have had kidney transplants. It is not known if Astagraf XL is safe and effective in children under 16 years of age who have had kidney transplants.
Astellas Pharma US, Inc., is dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.