Nebenwirkungen · Zydelig
Zydelig 100 mg film-coated tablets Zydelig 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13
HOS-132134 · Präparat HOS-097192
Infections (see section 4.4) Higher frequencies of infections overall, including Grade 3 and 4 infections, were observed in the idelalisib arms compared to the control arms of idelalisib clinical studies. Most frequently observed were infections in the respiratory system and septic events. In many instances the pathogen was not identified; however, both conventional and opportunistic pathogens, including PJP and CMV, were among those identified. Nearly all PJP infections, including fatal cases, occurred in the absence of PJP prophylaxis. There have been cases of PJP after stopping idelalisib 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 2024-10-21T17:52:00Z · SHA-256 f55f90ba278a87ef1c8e7162344ed4bd66ac7180deaf4c8fda3eca5bbf8e87e5 · Passage 199d2da5a78c52fbe222323742c1ed119245df85ea9360fa2dbd252e404c7a43 · Zeichen 4448–5057 im Abschnitt