Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Darzalex

DARZALEX 20 mg/mL concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 11–12

HOS-134732 · Präparat HOS-097602

The median time to onset of a reaction was 1.5 hours (range: 0 to 72.8 hours). The incidence of infusion modifications due to reactions was 36%. Median durations of 16 mg/kg infusions for the 1st week, 2nd week and subsequent infusions were approximately 7, 4 and 3 hours respectively. Severe IRRs included bronchospasm, dyspnoea, laryngeal oedema, pulmonary oedema, ocular adverse reactions (including choroidal effusion, acute myopia and acute angle closure glaucoma), hypoxia, and hypertension. Other adverse IRRs included nasal congestion, cough, chills, throat irritation, blurred vision, vomiting and nausea (see section 4.4). 11 When DARZALEX dosing was interrupted in the setting of ASCT (study MMY3006) for a median of 3.75 (range: 2.4; 6.9) months, upon re-initiation of DARZALEX the incidence of IRRs was 11% at first infusion following ASCT. Infusion rate/dilution volume used upon re-initiation was that used for the last DARZALEX infusion prior to interruption due to ASCT. IRRs occurring at re-initiation of DARZALEX following ASCT were consistent in terms of symptoms and severity (grade 3/4: < 1%) with those reported in previous studies at week 2 or subsequent infusions.

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