THURSDAY, June 16 (HealthDay News) — Nulojix (belatacept) has been approved by the U.S. Food and Drug Administration to prevent rejection of a transplanted kidney in adults.
The immunosuppressant drug is among a class called selective T-cell costimulation blockers. Without immune-suppressing drugs, the immune system could recognize the transplanted organ as foreign, leading to organ rejection, the agency said in a news release.
Nulojix was considered safe and effective after being evaluated in clinical studies involving more than 1,200 patients. Common adverse reactions recorded during the trials included anemia, constipation, kidney infection, and swelling of the ankles, legs or feet, the FDA said.
The new drug, designed to be injected with other immunosuppressants, will carry a boxed warning for increased risk of post-transplant lymphoproliferative disorder (PTLD), a form of cancer characterized by excessive white blood cell growth after an organ transplant. A separate label warning will note an increased risk of other forms of cancer, as well as serious infections, the FDA said.
Nulojix is marketed by Bristol-Myers Squibb, Princeton, N.J.
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