Document resource
Niraparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, has become a key therapeutic option in the management of ovarian cancer. Its safety profile is well characterised, with haematological adverse effects such as anaemia, thrombocytopenia and neutropenia being the most frequently described. Nevertheless, experience in clinical practice shows that additional toxicities may occur, some of which are not adequately reflected in current regulatory documents. One of these is hypomagnesaemia, which is absent from the European Medicines Agency (EMA) Summary of Product Characteristics (SmPC),1 despite being documented in pivotal clinical trials with an incidence of up to 39%.2 This gap between trial evidence and official labelling may result in insufficient awareness among clinicians, delaying recognition and management.