Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Pomalidomide Zentiva

Pomalidomide Zentiva 1 mg hard capsules Pomalidomide Zentiva 2 mg hard capsules Pomalidomide Zentiva 3 mg hard capsules Pomalidomide Zentiva 4 mg hard capsules · Abschnitt 4.8 · PDF-Seite 19

HOS-152482 · Präparat HOS-100765

Peripheral neuropathy - Pomalidomide in combination with bortezomib and dexamethasone Patients with ongoing peripheral neuropathy ≥ Grade 2 with pain within 14 days prior to randomisation were excluded from clinical trials. Peripheral neuropathy occurred in 55.4 % of patients (10.8% Grade 3; 0.7% Grade 4). Exposure-adjusted rates were comparable across treatment arms. Approximately 30% of the patients experiencing peripheral neuropathy had a history of neuropathy at baseline. Peripheral neuropathy led to discontinuation of bortezomib in approximately 14.4% of patients, pomalidomide in 1.8% and dexamethasone in 1.8% of patients in the Pom+Btz+Dex arm and 8.9% of patients in the Btz+Dex arm.

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