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Human medicines European public assessment report (EPAR): Breyanzi, lisocabtagene maraleucel, Lymphoma, Large B-Cell, Diffuse;Lymphoma, Follicular;Mediastinal Neoplasms, Date of authorisation: 04/04/2022, Revision: 1, Status: Authorised

For the full list of side effects and restrictions of Breyanzi, see the package leaflet.

The most common side effects with Breyanzi (which may affect more than 1 in 10 people) include neutropenia (decreases in neutrophils, a type of white blood cell that fights infections), anaemia (decreases in red blood cells) or thrombocytopenia (decreases in blood platelets, components that help the blood to clot), as well as cytokine release syndrome (a potentially life-threatening condition that can cause fever, vomiting, shortness of breath, pain and low blood pressure). In patients who had received two or more previous treatments with systemic therapy, more than 1 in 10 people also experienced tiredness. 

A very common serious side effect with Breyanzi (which may affect more than 1 in 10 people) is cytokine release syndrome. 

In patients who previously received a single course of treatment, common serious side effects (which may affect up to 1 in 10 people) include neutropenia, anaemia and thrombocytopenia, neutropenia with fever, fever, infections, aphasia (problems with the use of language), headache, confusion, pulmonary embolism (a blood clot in a blood vessel in the lungs), upper gastrointestinal haemorrhage and shaking. 

In patients who had received two or more previous treatments with systemic therapy, common serious side effects (which may affect up to 1 in 10 people) include low levels of neutrophils, red blood cells or platelets, low levels of neutrophils with fever, fever, infections, encephalopathy (a brain disorder caused by infection), aphasia, confusion, shaking or low blood pressure.

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