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Human medicines European public assessment report (EPAR): Gavreto, pralsetinib, Carcinoma, Non-Small-Cell Lung, Date of authorisation: 18/11/2021, Revision: 5, Status: Authorised

The most common side effects with Gavreto (which may affect more than 3 in 10 people) are anaemia (low levels of red blood cells), neutropenia (low levels of neutrophils, a type of white blood cell), constipation, bone or muscle pain, tiredness, leukopenia (low levels of white blood cells), an increased amount of aminotransferases (liver enzymes), and increased blood pressure. The most common serious side effects are pneumonia (lung infections), pneumonitis (lung inflammation) and severe anaemia. Other common side effects include haemorrhage (bleeding) (more than 1 in 10 people) and QT prolongation (a change in the heart’s electrical activity) (more than 1 in 100 people).

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

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