Nebenwirkungen · Jemperli
JEMPERLI 500 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 11
HOS-145345 · Präparat HOS-099336
In patients with primary advanced or recurrent EC (N = 241), the most common adverse reactions (≥ 10 %) were rash (23.2 %), rash maculopapular (14.5 %), hypothyroidism (14.5 %), pyrexia (12.9 %), alanine aminotransferase increased (12.9 %), aspartate aminotransferase increased (12.0 %) and dry skin (10.0 %). JEMPERLI was permanently discontinued due to adverse reactions in 12 (5.0 %) patients; most were immune-related events. Adverse reactions were serious in 5.8 % of patients. The most frequent (>1 %) serious adverse reaction was pyrexia (2.9 %). The most frequent (>10 %) immune-related adverse reaction was hypothyroidism (12.0 %), with maculo-papular rash (1.2 %) the most frequent (>1 %) immune-related adverse reaction leading to treatment discontinuation (see section 4.4).
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 2026-10-13T11:00:00Z · SHA-256 c9cfea3ac27190f9161acc3184a04c8f1d0df0ea11733d3f3f64b1b633b93895 · Passage 08fd73cc3b9c9af9b87cacb803a35ea6a725df7e17256eae182300067f24f69b · Zeichen 1897–2683 im Abschnitt