Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Alecensa

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

HOS-135896 · Präparat HOS-097784

Severe myalgia and CPK elevations Cases of myalgia (35.3 %) including myalgia events (24.2 %), arthralgia (16.3 %), and musculoskeletal pain (0.8 %) have been reported in patients treated with Alecensa across clinical trials. The majority of events were Grades 1 or 2 and five patients (0.9 %) had a Grade 3 event. Dose modifications of Alecensa treatment due to these adverse events were required for nine patients (1.7 %); Alecensa treatment was not withdrawn due to these events of myalgia. Elevations of CPK occurred in 56.2 % of 491 patients with CPK laboratory data available across clinical trials with Alecensa. The incidence of Grade ≥ 3 elevations of CPK was 5.5 %. Median time to Grade ≥ 3 CPK elevation was 15 days across trials. Dose modifications for elevation of CPK occurred in 5.4 % of patients; withdrawal from Alecensa treatment did not occur due to CPK elevations. In the clinical trial BO28984, severe arthralgia was reported in one patient (0.7 %) in the alectinib arm and in two patients (1.3 %) in the crizotinib arm. Grade ≥ 3 elevation of CPK was reported for 3.3 % of patients receiving Alecensa and 4.6 % of patients receiving crizotinib.

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