Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Mekinist

Mekinist 0.5 mg film-coated tablets Mekinist 2 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 17

HOS-128012 · Präparat HOS-096501

Haemorrhagic events, including major haemorrhagic events and fatal haemorrhages, occurred in patients taking trametinib as monotherapy and in combination with dabrafenib. The majority of bleeding events were mild. Fatal intracranial haemorrhages occurred in the integrated safety population of trametinib in combination with dabrafenib in <1% of patients. The median time to onset of the first occurrence of haemorrhagic events for the combination of trametinib and dabrafenib was 94 days in the melanoma Phase III studies and 75 days in the NSCLC study for the patients who had received prior anti-cancer therapy.

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