Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Revlimid

Revlimid 2.5 mg hard capsules Revlimid 5 mg hard capsules Revlimid 7.5 mg hard capsules Revlimid 10 mg hard capsules Revlimid 15 mg hard capsules Revlimid 20 mg hard capsules Revlimid 25 mg hard capsules · Abschnitt 4.8 · PDF-Seite 37

HOS-117151 · Präparat HOS-094537

Common Weight decreased, Blood Bilirubin increased ^ see section 4.8 description of selected adverse reactions Algorithm applied for follicular lymphoma: Controlled– Phase 3 trial: o NHL-007 ADRs- All treatment-emergent AEs with ≥ 5.0% of subjects in lenalidomide/rituximab arm and at least 2.0% higher frequency (%) in Len arm compared to control arm - (Safety population) o NHL-007 Gr 3/4 ADRs- All Grades 3 or Grade 4 treatment-emergent AEs with at least 1.0% subjects in lenalidomide/rituximab arm and at least 1.0% higher frequency in lenalidomide arm compared to control arm - (safety population) o NHL-007 Serious ADRs- All serious treatment-emergent AEs with at least 1.0% subjects in lenalidomide/rituximab arm and at least 1.0% higher frequency in lenalidomide/rituximab arm compared to control arm - (safety population) FL single arm – phase 3 trial: o NHL-008 ADRs- All treatment-emergent adverse events with ≥ 5.0% of subjects o NHL-008 Gr 3/4 ADRs- All Grade 3/4 treatment-emergent adverse events reported in ≥ 1.0% of subjects o NHL-008 Serious ADRs- All serious treatment-emergent adverse events reported in ≥ 1.0% of subjects ◊ Adverse events reported as serious in follicular lymphoma clinical trials + Applies to serious adverse drug reactions only * Rash includes PT of rash and rash maculo-papular ** Leucopenia includes PT leucopenia and white blood cell count decreased *** Lymphopenia includes PT lymphopenia and lymphocyte count decreased

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