Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Ituxredi

Ituxredi 100 mg concentrate for solution for infusion Ituxredi 500 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 25

HOS-152173 · Präparat HOS-100701

Table 5 Adverse reactions occurring at 6-months in ≥ 5% of adult patients receiving rituximab in GPA/MPA Study 1 (rituximab n=99), at a higher frequency than the comparator group, or during post-marketing surveillance MedDRA System Organ Class Very Common Common Not known Infections and infestations urinary tract infection, serious viral infection1,2, bronchitis, enteroviral herpes zoster, meningoencephalitis1 nasopharyngitis Blood and lymphatic system thrombocytopenia disorders Immune system disorders cytokine release syndrome Metabolism and nutrition hyperkalaemia disorders Psychiatric disorders insomnia Nervous system disorders dizziness, tremor Vascular disorders hypertension flushing Respiratory, thoracic and cough, nasal congestion mediastinal disorders dyspnoea, epistaxis Gastrointestinal disorders diarrhoea dyspepsia, constipation Skin and subcutaneous tissue acne disorders Musculoskeletal and muscle spasms, muscle weakness, connective tissue disorders arthralgia, musculoskeletal pain, back pain pain in extremities General disorders and oedema peripheral administration site conditions Investigations decreased haemoglobin 1 Observed during post-marketing surveillance. 2 See also section infections below.

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