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 15

HOS-135847 · Präparat HOS-097776

Gastrointestinal (GI) perforation (see section 4.4) In the RCC study (METEOR), GI perforations were reported in 0.9% (3/331) of cabozantinib-treated RCC patients. Events were Grade 2 or 3. Median time to onset was 10.0 weeks. In the treatment-naïve RCC study (CABOSUN), GI perforations were reported in 2.6% (2/78) of cabozantinib-treated patients. Events were Grade 4 and 5. In the HCC study (CELESTIAL), GI perforations were reported in 0.9% of cabozantinib-treated patients (4/467). All events were Grade 3 or 4. Median time to onset was 5.9 weeks. In the DTC study (COSMIC-311), GI perforation grade 4 was reported in one patient (0.6%) of cabozantinib-treated patients and occurred after 14 weeks of treatment. In the NET study (CABINET), GI perforations were reported in 1.3% of cabozantinib-treated patients (3/227). Events were Grade 3, 4 and 5. Median time to onset was 21.6 weeks. In combination with nivolumab in advanced RCC in first-line treatment (CA2099ER) the incidence of GI perforations was 1.3% (4/320) treated patients. One event was grade 3, two events were grade 4 and one event was grade 5 (fatal). Fatal perforations have occurred in the cabozantinib clinical program.

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