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Generic Transplant Drugs as Good as Brand Name

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 3rd 2105 at the American Transplant Congress annual meeting in Philadelphia 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.

A release from the university explains that the research was funded by the U.S. Food and Drug Administration (FDA). The study was a prospective, blinded, six-way crossover study in kidney and liver transplant patients. It tested whether the two most disparate generics, based on potency, purity and dissolution (“Generic Hi” and “Generic Lo”), are bioequivalent to the drug tacrolimus (Prograf) in stable transplant patients.

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.

The release quotes Alloway as saying, “We found there to be essentially no difference in the formulations between the generics and brand-name version.In other words, if you were on brand and switched to generic–and you take your medication as instructed–there should be no clinical consequence.”

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.

To analyze drug levels and pharmacokinetics as well as pharmacogenetics, Alloway collaborated with Uwe Christians, MD, PhD, professor of anesthesiology at the University of Colorado, and Sander Vinks, PharmD, PhD, UC professor of pediatrics and director of the Division of Clinical Pharmacology at Cincinnati Children’s Hospital Medical Center.


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