Generic formulations of tacrolimus were found to be just as good as the brand Prograf (Astellas) version, researchers from the University of Cincinnati have found. Findings from the study were presented at the 2015 American Transplant Congress Annual Meeting.
Rita Alloway, PharmD, and colleagues conducted a prospective, blinded, 6-way crossover study in 70 kidney and liver transplant patients. The team studied whether the two most disparate generics – “Generic Hi” and “Generic Lo” – were bioequivalent to tacrolimus in stable transplant patients. Patients were given brand name tacrolimus or one of the two generic versions.
They found no difference in the formulations between the generics and brand-name versions based on potency, purity, and dissolution. Although >70% of tacrolimus is dispensed as generic with no consistent negative reports, physicians and patients still express concern over the use of generic versions post-transplant.
Researchers still emphasize the importance in reporting any product concerns to the Food and Drug Administration (FDA). The team plans to continue more research through a study of patients who are at risk of experiencing lower concentrations and rejection episodes because they have been shown to require lager doses of tacrolimus to attain therapeutic blood concentrations.
Tacrolimus is an immunosuppressant indicated for organ rejection prophylaxis in allogeneic hepatic transplant patients, in combination with corticosteroids; or in cardiac and renal transplant patients in combination with corticosteroids, azathioprine, or mycophenolate mofetil (MMF).
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