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

HOS-135851 · Präparat HOS-097776

Fistulas (see section 4.4) In the RCC study (METEOR), fistulas were reported in 1.2% (4/331) of cabozantinib-treated patients and included anal fistulas in 0.6% (2/331) cabozantinib-treated patients. One event was Grade 3; the remainder were Grade 2. Median time to onset was 30.3 weeks. In the treatment-naïve RCC study (CABOSUN), no cases of fistulas were reported. In the HCC study (CELESTIAL), fistulas were reported in 1.5% (7/467) of the HCC patients. Median time to onset was 14 weeks. In the DTC study (COSMIC-311), fistulas (two anal and one pharyngeal fistula) were reported in 1.8 % (3/170) of the cabozantinib treated patients. In the NET study (CABINET), fistulas (two anal and one biliary fistula) were reported in 1.3 % (3/227) of the cabozantinib treated patients. Anal fistula events were Grade 1 and 3, biliary fistula was Grade 2. Median time to onset was 19.3 weeks.

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