Nulojix Approved by FDA for Kidney Transplant Patients

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Nulojix (belatacept) has received U.S. Food and Drug Administration approval for use in preventing acute rejection in adult patients who have had a kidney transplant.

It has been almost six years since the New England Journal of Medicine published the report on the safety and efficacy of belatacept during a randomized phase II clinical study of 218 patients, conducted at 22 centers in the United States, Canada and seven European countries.

Nulojix is a selective T-cell costimulation blocker which works by binding surface costimulatory ligands (CD80 and CD86) of antigen-presenting cells. The interaction of CD80 and CD86 with the surface costimulatory receptor CD28 of T cells is required for full activation of T cells which can result in rejection of the transplanted kidney. By blocking this costimulation, Nulojix helps to prevent organ rejection after a kidney transplant.

Nulojix is given through 30 minute intravenous (IV) infusions intermittently. Protocols may vary but often involve giving Nulojix on transplant day 1, day 5, then q2Weeks for 1-3 months; and then a monthly maintenance dose.

Nulojix is approved for use with other immunosuppressants (medications that suppress the immune system) -- specifically basiliximab, mycophenolate mofetil, and corticosteroids.

“Nulojix is a new option for kidney transplant patients,” said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “This new medication used in combination with other immunosuppressants helps control the immune system and prevents organ rejection in patients receiving kidney transplants.”

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Nulojix was evaluated in two open-label, randomized, multicenter, controlled Phase 3 studies that enrolled more than 1,200 patients that compared two dose regimens of Nulojix with another immunosuppressant, cyclosporine. These trials demonstrated that the recommended Nulojix regimen is safe and effective for the prevention of acute organ rejection.

Common adverse reactions observed in transplant patients in the trials included low red blood count (anemia), constipation, kidney or bladder infection, and swollen legs, ankles, or feet.

Long-term immunosuppression increases the risks of infection and cancer, including skin cancers. Therefore, any transplant patients, including those receiving Nulojix, should limit the amount of time spent in sunlight because of the risk of skin cancer and should not get live vaccines because of the risk of infection.

Nulojix carries a Boxed Warning for an increased risk of developing post-transplant lymphoproliferative disorder (PTLD), a type of cancer where white blood cells grow out of control after an organ transplant. The risk of PTLD is higher for transplant patients who have never been exposed to Epstein-Barr virus (EBV), the cause of mononucleosis. Transplant patients who have not been exposed to EBV have more difficulty mounting an effective immune response to the virus if they get infected after transplant; typically they get exposed to the virus at time of transplant, as it is carried in around 80 percent of donated organs. Patients should be tested for EBV and should only receive Nulojix if the test shows they have already been exposed to EBV. Another Boxed Warning on the Nulojix label, as well as labels of other immunosuppressants, warns of an increased risk of serious infections and other cancers.

Nulojix is marketed by Princeton, N.J.-based Bristol-Myers Squibb Company.

Source
Food and Drug Administration

Costimulation Blockade with Belatacept in Renal Transplantation; Flavio Vincenti, M.D., et al; N Engl J Med 2005; 353:770-781, August 25, 2005

Rejection of the Kidney Allograft; Brian J. Nankivell, M.D., Ph.D., and Stephen I. Alexander, M.B., B.S., M.P.H.; N Engl J Med 2010; 363:1451-1462, October 7, 2010

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