Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Plegridy

Plegridy 63 micrograms solution for injection in pre-filled syringe Plegridy 94 micrograms solution for injection in pre-filled syringe Plegridy 125 micrograms solution for injection in pre-filled syringe Plegridy 63 micrograms solution for injection in pre-filled pen Plegridy 94 micrograms solution for injection in pre-filled pen Plegridy 125 micrograms solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-130118 · Präparat HOS-096849

Haematological disorders Decreases in white blood cell (WBC) counts of <3.0 x 109/L were observed in 7% of patients receiving peginterferon beta-1a and in 1% receiving placebo. Mean WBC counts remained within normal limits in patients treated with peginterferon beta-1a. Decreases in WBC counts were not associated with an increased risk of infections or serious infections. The incidence of potentially clinically significant decreases in lymphocyte counts (<0.5 x 109/L) (<1%), neutrophil counts (≤1.0 x 109/L) (<1%) and platelet counts (≤100 x 109/L) (≤1%) was similar in peginterferon beta-1a- treated patients compared to placebo-treated patients. Two serious cases were reported in patients treated with peginterferon beta-1a: one patient (<1%) experienced severe thrombocytopenia (platelet count <10 x 109/L), another patient (<1%) experienced severe neutropenia (neutrophil count <0.5 x 109/L). In both patients, cell counts recovered after discontinuation of peginterferon beta-1a. Slight decreases in mean red blood cell (RBC) counts were observed in peginterferon beta-1atreated patients. The incidence of potentially clinically significant decreases in RBC counts (<3.3 x 1012/L) was similar in peginterferon beta-1a treated patients compared to placebo- treated- patients.

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