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Human medicines European public assessment report (EPAR): Nulojix, belatacept, Date of authorisation: 17/06/2011, Revision: 21, Status: Authorised

The most common serious side effects of Nulojix seen in more than 2% of patients are urinary-tract infection (infection of the structures that carry urine), cytomegalovirus infection, pyrexia (fever), increased blood creatinine (a marker of kidney problems), pyelonephritis (kidney infection), diarrhoea, gastroenteritis (diarrhoea and vomiting), poor functioning of the transplanted kidney, leucopenia (low white blood cell counts), pneumonia (infection of the lungs), basal-cell carcinoma (a cancer), anaemia (low red-blood-cell counts) and dehydration. For the full list of all side effects reported with Nulojix, see the package leaflet.

Nulojix must not be used in patients who have not been exposed to the Epstein-Barr virus or in whom previous exposure is uncertain. This is because patients treated with Nulojix who have had no previous exposure to the virus are at higher risk of getting a type of cancer known as post-transplant lymphoproliferative disorder. For the full list of restrictions, see the package leaflet.

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