Study found Generic tacrolimus is as good as brand name version

A University of Cincinnati (UC)-led research team has found that generic formulations of tacrolimus, a drug used post-transplant to lower the risk of organ rejection, are just as good as the name-brand version.

The findings were presented Sunday, May 3, by lead investigator Rita Alloway, PharmD, UC research professor of medicine and director of transplant clinical research within the UC Department of Internal Medicine, and her study collaborators at the 2015 American Transplant Congress annual meeting in Philadelphia.

The researchers analyzed a total of 70 patients who were transplanted at either University of Cincinnati Medical Center or The Christ Hospital (Cincinnati) transplant programs. Patients were given brand name tacrolimus or one of two generic versions.

"We found there to be essentially no difference in the formulations between the generics and brand-name version," says Alloway. Alloway stresses, however, that despite their team's findings, patients are still encouraged to report any product concerns to the FDA. The findings are important, says Alloway, because while more than 70 percent of tacrolimus dispensed is generic--with no consistent negative reports--physicians and patients still have concern over the use of generics post-transplant.

"Most immunosuppressant drugs require individualized dosing and careful management to ensure the proper blood concentrations are maintained," says Alloway. "Too high exposure to these drugs increases the risk of toxicity, over-immunosuppression and cancer in patents. Too low exposure may lead to rejection of the organ by the patient's immune system."

Alloway says it's these strict conditions that cause concern that the quality, pharmacokinetics and therapeutic efficacy of new drugs may differ from the branded, or innovator, product.


Tags :