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Human medicines European public assessment report (EPAR): Ebvallo, tabelecleucel, Date of authorisation: 16/12/2022, Revision: 3, Status: Authorised

The most common side effects with Ebvallo (which may affect more than 1 in 10 people) are fever, diarrhoea, tiredness, nausea (feeling sick), anaemia (low levels of red blood cells), decreased appetite, hyponatraemia (low blood sodium levels), abdominal (belly) pain, low levels of white blood cells, including neutrophils (white blood cells that fights infections), increased blood levels of aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase (signs of possible liver damage), constipation, hypoxia (low blood oxygen levels), dehydration, hypotension (low blood pressure), nasal congestion and rash.

The most serious adverse reactions, which may affect up to 1 in 10 people, are tumour flare reaction (a reaction to certain medicines that act on the immune system which is similar to worsening of the cancer; symptoms may include painful and swollen lymph nodes, enlarged spleen, slight fever, bone pain and skin rash) and graft-versus-host disease (when transplanted cells attack the body).

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

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