Nebenwirkungen · Lynparza
Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15–16
HOS-130535 · Präparat HOS-096931
15 Myelodysplastic syndrome/Acute myeloid leukaemia MDS/AML are serious adverse reactions that occurred uncommonly in monotherapy clinical studies at the therapeutic dose, across all indications (0.9%). The incidence was 0.5% including events reported during the long term safety follow up (rate calculated based on overall safety population of 18576 patients exposed to at least one dose of oral olaparib in clinical studies). All patients had potential contributing factors for the development of MDS/AML, having received previous chemotherapy with platinum agents. Many had also received other DNA damaging agents and radiotherapy. The majority of reports were in germline breast cancer susceptibility gene 1 or 2 (gBRCA1/2) mutation carriers. The incidence of MDS/AML cases was similar among gBRCA1m and gBRCA2m patients (1.6% and 1.2%, respectively). Some of the patients had a history of previous cancer or of bone marrow dysplasia.
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