Astellas Pharma US, in Deerfield, Ill., has received approval for the use of Prograf (tacrolimus) in conjunction with mycophenolate mofetil (MMF) in kidney transplant recipients.
The use of tacrolimus with MMF “has been an accepted and successful immunosuppressant regimen for the transplant community for more than 10 years,” according to Flavio Vincenti, MD, Professor of Clinical Medicine at the University of California at San Francisco.
In a phase 3 trial that was partly the basis for the FDA approval, patients who received tacrolimus/MMF and those who received cyclosporine/MMF had similar rates of the combined end point of biopsy-proven acute rejection, graft failure, death, and/or lost to follow-up at 12 months.
A second study found that patients in the tacrolimus group exhibited higher estimated creatinine clearance rates and experienced fewer efficacy failures than cyclosporine/MMF or sirolimus (Siro)/MMF recipients. Tacrolimus is contraindicated in patients with hypersensitivity to tacrolimus or castor oil.
The most common adverse events include tremor, headache, hypertension, GI disturbance, abnormal renal function, hyperglycemia, leukopenia, cytomegalovirus infection, and hyperlipemia.