Human medicines European public assessment report (EPAR): Fulphila, pegfilgrastim, Neutropenia, Date of authorisation: 20/11/2018, Revision: 11, Status: Authorised
Fulphila is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (when neutropenia is accompanied by fever).
Fulphila is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia).
Fulphila is a ‘biosimilar medicine’. This means that Fulphila is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Fulphila is Neulasta.
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