Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Retsevmo

Retsevmo 40 mg hard capsules Retsevmo 80 mg hard capsules · Abschnitt 4.8 · PDF-Seite 15

HOS-146865 · Präparat HOS-099572

Hypersensitivity Signs and symptoms of hypersensitivity included fever, rash and arthralgias or myalgias with concurrent decreased platelets or increased aminotransferase. In study LIBRETTO-001, 24.0% (201/837) of patients treated with selpercatinib had previously received anti-PD-1/PD-L1 immunotherapy. Hypersensitivity occurred in a total of 5.7% (48/837) of patients receiving selpercatinib, including Grade 3 hypersensitivity in 1.9% (16/837) of patients. Of the 48 patients with hypersensitivity in LIBRETTO-001, 54.2% (26/48) had NSCLC and had received prior anti-PD-1/PD-L1 immunotherapy. Grade 3 hypersensitivity occurred in 3.5% (7/201) of the patients previously treated with anti-PD-1/PD-L1 immunotherapy in LIBRETTO-001. 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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