Nebenwirkungen · Retsevmo
Retsevmo 40 mg hard capsules Retsevmo 80 mg hard capsules · Abschnitt 4.8 · PDF-Seite 15
HOS-146866 · Präparat HOS-099572
Haemorrhages Grade ≥3 haemorrhagic events occurred in 2.5% of patients treated with selpercatinib across studies LIBRETTO-001, LIBRETTO-431 and LIBRETTO-531. In LIBRETTO-001 this included 4 (0.5%) patients with fatal haemorrhagic events, two cases of cerebral haemorrhage, and one case each of tracheostomy site haemorrhage, and haemoptysis. No fatal haemorrhagic events were reported in patients treated with selpercatinib in LIBRETTO-431 or LIBRETTO-531. The median time to onset was 34.1 weeks (range: 0.1 week to 234.6 weeks) in LIBRETTO-001, 16.8 weeks (range: 1.1 to 94.1 weeks) in LIBRETTO-431, and 10.7 weeks (range: 1.0 to 124.1 weeks) in LIBRETTO-531. Selpercatinib should be discontinued permanently in patients with life-threatening or recurrent severe haemorrhage (see section 4.2).
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