Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Retsevmo

Retsevmo 40 mg film-coated tablets Retsevmo 80 mg film-coated tablets Retsevmo 120 mg film-coated tablets Retsevmo 160 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 48–49

HOS-146917 · Präparat HOS-099572

48 In LIBRETTO-001, the median time to onset was 1.9 weeks (range: 0.7 to 203.9 weeks): 1.7 weeks in patients with previous anti-PD-1/PD-L1 immunotherapy and 4.4 weeks in patients who were anti-PD-1/PD-L1 immunotherapy naïve. Study LIBRETTO-431 enrolled patients with advanced or metastatic NSCLC. Hypersensitivity occurred in a total of 1.9% (3/158) of patients receiving selpercatinib, including Grade 3 hypersensitivity in 0.6% (1/158) of patients. In an integrated analysis of patients with NSCLC receiving selpercatinib who were previously treated with anti-PD-1/PD-L1 therapy based on studies LIBRETTO-001 and LIBRETTO-431 (N=205), hypersensitivity occurred in 16.6% of patients, including ≥Grade 3 hypersensitivity in 5.9% of patients. Study LIBRETTO-531 enrolled patients with advanced or metastatic MTC. Hypersensitivity occurred in 1 patient (0.5% [1/193]) receiving selpercatinib. This 1 patient experienced Grade 3 hypersensitivity. Retsevmo may require dose interruption or modification (see section 4.2).

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