Nebenwirkungen · Erleada
Erleada 60 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 10
HOS-139398 · Präparat HOS-098330
Hypothyroidism was reported for 8% of patients treated with apalutamide and 2% of patients treated with placebo based on assessments of thyroid-stimulating hormone (TSH) every 4 months. There were no grade 3 or 4 adverse events. Hypothyroidism occurred in 30% of patients already receiving thyroid replacement therapy in the apalutamide arm and in 3% of patients in the placebo arm. In patients not receiving thyroid replacement therapy, hypothyroidism occurred in 7% of patients treated with apalutamide and in 2% of patients treated with placebo. Thyroid replacement therapy, when clinically indicated, should be initiated or dose-adjusted (see section 4.5).
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Version 2026-04-22T12:55:00Z · SHA-256 0e855910bdce0fdee217ba5d06d9b56e25e15ba99cd5eb9f6069185d820c69fe · Passage c53e152ef62ec0ac0a1caceda3b36accf6affefd2d319acf28992dbc9675c804 · Zeichen 8187–8847 im Abschnitt