Human medicines European public assessment report (EPAR): Imjudo, tremelimumab, Carcinoma, Hepatocellular, Date of authorisation: 20/02/2023, Revision: 1, Status: Authorised
The most common side effects with Imjudo in combination with durvalumab (which may affect more than 1 in 10 people) are rash, pruritus (itching), diarrhoea, abdominal (belly) pain, increased levels of liver enzymes, fever, hypothyroidism (an underactive thyroid gland), cough, peripheral oedema (swelling especially of the ankles and feet) and increased level of lipase (an enzyme that helps digest fat, mainly made in the pancreas).
The most common serious side effects (which may affect up to 1 in 10 people) are colitis (inflammation in the large bowel), diarrhoea, pneumonia (infection of the lungs) and hepatitis (inflammation of the liver).
Imjudo is commonly associated with side effects related to the activity of the immune system on body organs, such as immune-mediated colitis, hepatitis and hypothyroidism.
For the full list of side effects and restrictions of Imjudo, see the package leaflet.
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