Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Alecensa

Alecensa 150 mg hard capsules · Abschnitt 4.8 · PDF-Seite 11

HOS-135892 · Präparat HOS-097784

Adverse reactions of bilirubin elevations were reported in 25.9 % of the patients treated with Alecensa across clinical trials. The majority of the events were of Grade 1 and 2 intensity; Grade ≥ 3 events were reported in 3.9 % of the patients. The events generally occurred during the first 3 months of treatment, were usually transient and the majority resolved upon dose modification. In 8.3 % of patients, bilirubin elevations led to dose modifications and in 2.1 % of patients, bilirubin elevations led to withdrawal from Alecensa treatment. In the phase III clinical trial BO28984, Grade 3 or 4 bilirubin elevations occurred in 5.9 % of patients receiving Alecensa versus no patient receiving crizotinib.

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