Nebenwirkungen · Alecensa
Alecensa 150 mg hard capsules · Abschnitt 4.8 · PDF-Seite 11
HOS-135895 · Präparat HOS-097784
Bradycardia Cases of bradycardia (11.3 %) of Grade 1 or 2 have been reported in patients treated with Alecensa across clinical trials. No patients had events of Grade 3 severity. There were 102 of 521 patients (19.6 %) treated with Alecensa, for whom serial ECGs were available, had post-dose heart rate values below 50 beats per minute (bpm). In the phase III clinical trial BO28984 12.4 % of patients treated with Alecensa had post-dose heart rate values below 50 bpm versus 17.6 % of patients treated with crizotinib. Patients who develop symptomatic bradycardia should be managed as recommended in sections 4.2 and 4.4. No case of bradycardia led to withdrawal from Alecensa treatment.
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 2026-03-31T12:39:00Z · SHA-256 c661360f23ce41296ba8174d095b12ebdf58fe24b9cabe9f90341e85e092a395 · Passage 0718b408c247edb38173e8e4c7c480e9ac66f925c2ee66938c42761e9d4f544a · Zeichen 9907–10598 im Abschnitt