Nebenwirkungen · Rubraca
Rubraca 200 mg film-coated tablets Rubraca 250 mg film-coated tablets Rubraca 300 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 9–10
HOS-137480 · Präparat HOS-098043
9 to at least one dose of oral rucaparib in all clinical studies). In the placebo-controlled Phase 3 studies, ARIEL3 and ATHENA-MONO, the incidence of MDS/AML during therapy in patients who received rucaparib was 1.6% and 0.5%, respectively. Although no cases were reported during therapy in patients who received placebo, six cases have been reported in placebo-treated patients during the long term safety follow up. All patients had potential contributing factors for the development of MDS/AML; in all cases, patients had received previous platinum-containing chemotherapy regimens and/or other DNA damaging agents. For risk mitigation and management, see section 4.4.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-11-27T16:36:00Z · SHA-256 230a9c1df880b14750043bea049c21874a6e3d04bb3b18b3f15c92b0c4aa3f16 · Passage 7bd0420b6e800573f8d9d2d3840c39fd945478f8b53e4fdce6edca7b64610ac4 · Zeichen 7281–7954 im Abschnitt