FDA logoAcute organ rejection seems to be a major risk for kidney transplant patients. The U.S. Food and Drug Administration has announced the approval of Nulojix also known as belatacept, to prohibit acute rejection in adult kidney transplant patients. The drug is approved for its utility with immunosuppressants particularly basiliximab, mycophenolate mofetil, and corticosteroids.

Nulojix is a type of drug known as selective T-cell costimulation blocker. The drug strives to inhibit organ rejection after a kidney transplant. Immunosuppression is essential because without it, the body may deny to accept a transplanted organ, considering it to be foreign. A combination of Nulojix and immunosuppressants may keep the new kidney active. Nulojix is administered through a 30 minute intravenous infusion process.

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

In the process of evaluating Nulojix, phase 3 studies in two open-label randomized, multi center were conducted. More than 1,200 patients participated in the study and the analysis drew a comparison between 2 dose regimens of Nulojix and one more immunosuppressant, cyclosporine. The test presented that the Nulojix regimen could be efficient in prohibiting acute organ rejection.

Nulojix is packed with a Boxed Warning for the growing risk of acquiring post-transplant lymphoproliferative disorder (PTLD). The disorder risk seems higher for patients who had never encountered the Epstein-Barr virus (EBV), which is subsequently the reason for monunucleosis.

Such patients apparently do not respond effectively to the virus if they develop an infection after the transplant. They may face exposure to the virus in the process of transplantation since it is known to be present in nearly 80 percent of donated organs. Hence there seems to be an obligation that only patients, who have previously encountered the virus, should be eligible for Nulojix therapy. Additionally, the drug packs also contain a warning stating the threat of serious infections and cancers.

Transplant patients are known to experience many effects during tests like anemia, constipation, kidney or bladder infection, and swollen legs, ankle or feet. These patients and even those on Nulojix treatment should restrict their exposure to sunlight for the risk of contracting skin cancer. Since their bodies are susceptible to infection, live injections are ought to be avoided.

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