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Why is there a black box warning for Nulojix?

There is a black box warning—that is, a warning on the label outlined in black—for Nulojix (belatacept), which lowers the risk of organ rejection in people who receive a kidney transplant, because there are a number of important cautions associated with this medicine, including:
  • You are at risk for a potentially life-threatening condition called post-transplant lymphoproliferative disorder (PTLD), a kind of cancer in which certain white blood cells grow rapidly and out of control.
  • You are to receive Nulojix only if a blood test reveals that you have been exposed to the Epstein-Barr virus (EBV), the same virus that causes mononucleosis. (Past exposure to EBV lowers your PTLD risk.)
  • You are not to receive Nulojix if you have previously been treated with medication to lower the number of T lymphocytes (a type of white blood cell) in your blood, since it will increase your PTLD risk.
  • You are not to receive Nulojix if you have been infected in the past with cytomegalovirus (CMV), since it will increase your PTLD risk.
  • You are at increased risk of fungal, viral, bacterial and protozoal infections, such as tuberculosis and progressive multifocal leukoencephalopathy (PML, a rare, serious brain infection).
  • You are to receive Nulojix only if you have received a kidney in a transplant procedure.
Only doctors who are experienced in administering immune-suppressing therapies and caring for people undergoing kidney transplantation should prescribe Nulojix.

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