New Immunosuppressive Approved for Kidney Transplant Recipients

The FDA recently approved Veloxis Pharmaceuticals' tacrolimus extended-release tablets to prevent organ rejection in kidney transplant patients.

The FDA recently approved Veloxis Pharmaceuticals’ tacrolimus extended-release tablets (Envarus XR) to prevent organ rejection in kidney transplant patients.

Veloxis anticipates that the product will be available in the United States in the fourth quarter of 2015.

The FDA’s approval was based on the results of several late-stage trials that demonstrated once-daily Envarus XR has a flatter pharmacokinetic profile and higher bioavailability than twice-daily, immediate-release tacrolimus (Prograf), the current leading transplant drug.

"We are very pleased to have a new treatment option available for kidney transplant recipients," said Anthony Langone, MD, associate professor and medical director of the Medical Specialties Clinic at

Vanderbilt University, in a press release. “Patients must receive immunosuppression as lifelong therapy, and Envarsus XR holds promise for kidney transplant patients and their physicians as a tacrolimus product with the convenience of once-daily dosing.”

Envarsus XR and other immunosuppressants are associated with an increased risk for developing serious infections and malignancies that may lead to hospitalization or death.

Other risks related to Envarsus XR include acute or chronic nephrotoxicity and mild to severe hyperkalemia. Hypertension is another common adverse effect of the drug and may require antihypertensive therapy.