Gastrointestinal CMV infection/reactivation with nivolumab

Abstract

Nivolumab [Opdivo] is linked with cases of gastrointestinal-associated cytomegalovirus (CMV) infection or reactivation, notes the UK’s MHRA in a Drug Safety Update. The immune checkpoint inhibitor is used to treat various cancers, either alone or in combination with ipilimumab [Yervoy], which has also been associated with CMV infection/reactivation. A European review found 20 serious cases suggestive of CMV infection/ reactivation with nivolumab monotherapy worldwide, and a further 8 cases of CMV infection or CMV hepatitis associated with nivolumab in combination with ipilimumab. Gastrointestinal CMV infection was suspected in 18 and 8 cases, respectively. Diarrhoea is very common in nivolumab recipients, generally of mild to moderate intensity, and resolves over time in most patients. However, patients who present with diarrhoea or other colitis symptoms and don’t respond to steroid treatment for immune-related colitis should be investigated to exclude other causes. The addition of another immunosuppressive drug should only be considered after other causes are considered. Patients are advised to contact their healthcare professional at symptoms onset. The MHRA encourages all suspected adverse reactions associated with ipilimumab to be reported via the Yellow Card Scheme.