Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Talzenna

Talzenna 0.1 mg hard capsules Talzenna 0.25 mg hard capsules Talzenna 0.35 mg hard capsules Talzenna 0.5 mg hard capsules Talzenna 1 mg hard capsules · Abschnitt 4.8 · PDF-Seite 8–9

HOS-140586 · Präparat HOS-098546

The most common (≥ 20%) adverse reactions in patients receiving talazoparib in these clinical studies were anaemia (55.6%), fatigue (52.5%), nausea (35.8%), neutropenia (30.3%), thrombocytopenia (25.2%) and decreased appetite (21.1%). The most common (≥ 10%) Grade ≥ 3 adverse reactions of talazoparib were anaemia (39.2%), neutropenia (16.5%) and thrombocytopenia (11.1%). 8 Dose modifications (dose reductions or dose interruptions) due to any adverse reaction occurred in 58.7% of patients receiving Talzenna 1 mg monotherapy. The most common adverse reactions leading to dose modifications were anaemia (33.5%), neutropenia (11.7%) and thrombocytopenia (9.9%). Permanent discontinuation due to an adverse reaction occurred in 2.9% of patients receiving Talzenna; the most common was anaemia (0.6%). The median duration of exposure was 5.6 months (range 0.0 to 70.2).

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