Substitution of brand name tacrolimus with generic proves safe for transplant recipients

The substitution of a brand name immunosuppressive drug with a generic (manufactured by Novartis generics unit Sandoz) for preventing rejection of transplanted organs appears to be safe for transplant recipients, according to a new study published in the American Journal of Transplantation.

Tacrolimus (Japanese drugmaker Astellas’ Prograf/Advagraf) is an immunosuppressive drug that is used to prevent rejection of transplanted organs following organ transplantation. In August 2009, another pharmaceutical company received approval from the FDA for a generic tacrolimus product.

In the first formal study of its kind, Raman Venkataramanan, of the University of Pittsburgh, School of Pharmacy and School of Medicine, and researchers analyzed database information regarding tacrolimus concentrations and indices of liver and kidney function before and after generic substitution in 48 liver and 55 kidney transplant recipients.