Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Cabometyx

CABOMETYX 20 mg film-coated tablets CABOMETYX 40 mg film-coated tablets CABOMETYX 60 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 16–17

HOS-135853 · Präparat HOS-097776

16 Haemorrhage (see section 4.4) In the RCC study (METEOR), the incidence of severe haemorrhagic events (Grade ≥ 3) was 2.1% (7/331) in cabozantinib-treated RCC patients. Median time to onset was 20.9 weeks. In the treatment-naïve RCC study (CABOSUN), the incidence of severe haemorrhagic events (Grade ≥ 3) was 5.1% (4/78) in cabozantinib-treated RCC patients. In the HCC study (CELESTIAL), the incidence of severe haemorrhagic events (Grade ≥ 3) was 7.3% in cabozantinib-treated patients (34/467). Median time to onset was 9.1 weeks. In the DTC study (COSMIC-311), the incidence of severe haemorrhagic events (grade ≥ 3) was 2.4% in cabozantinib-treated patients (4/170). Median time to onset was 11.5 weeks. In the NET study (CABINET), the incidence of severe haemorrhagic events (grade ≥ 3) was 1.8% in cabozantinib-treated patients (4/227). Median time to onset was 14.1 weeks. In combination with nivolumab in advanced RCC in first-line treatment (CA2099ER) the incidence of ≥ Grade 3 haemorrhage was in 1.9% (6/320) of treated patients. Fatal haemorrhages have occurred in the cabozantinib clinical program.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.