Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Columvi

Columvi 2.5 mg concentrate for solution for infusion Columvi 10 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 22

HOS-149243 · Präparat HOS-100012

Tumour flare Tumour flare was reported in 11.7% of patients who received Columvi monotherapy, including Grade 2 tumour flare in 4.8% of patients and Grade 3 tumour flare in 2.8% of patients. Tumour flare was reported involving lymph nodes in the head and neck presenting with pain and involving lymph nodes in the thorax with symptoms of breathlessness due to development of pleural effusion. Most tumour flare events (16/17) occurred during Cycle 1, and no tumour flare events were reported beyond Cycle 2. The median time to onset of tumour flare of any grade was 2 days (range: 1 to 16 days), and the median duration was 3.5 days (range: 1 to 35 days).

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