Human medicines European public assessment report (EPAR): Tremelimumab AstraZeneca, tremelimumab, Carcinoma, Non-Small-Cell Lung, Date of authorisation: 20/02/2023, Revision: 1, Status: Authorised
The most common side effects with Tremelimumab AstraZeneca in combination with durvalumab and chemotherapy (which may affect more than 2 in 10 people) are anaemia (low levels of red blood cells), nausea (feeling sick), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), tiredness, rash, thrombocytopenia (low levels of platelets in the blood) and diarrhoea.
The most common serious side effects (which may affect more than 2 in 10 people) are neutropenia and anaemia. Other serious side effects (which may affect up to 1 in 10 people) are pneumonia (infection of the lungs), thrombocytopenia, leucopenia (low levels of white blood cells), tiredness, neutropenia with fever, colitis (inflammation of the large intestine) and increased levels of liver enzymes and lipase (an enzyme that helps digest fat, mainly made in the pancreas).
Tremelimumab AstraZeneca is commonly associated with side effects related to the activity of the immune system on body organs, such as immune-mediated hypothyroidism (an underactive thyroid gland) and colitis.
For the full list of side effects and restrictions of Tremelimumab AstraZeneca, see the package leaflet.
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