Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Datroway

Datroway 100 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 9

HOS-153443 · Präparat HOS-100992

Table 3: Adverse reactions in patients treated with datopotamab deruxtecan 6 mg/kg System organ class Frequency categoryq Adverse reactions Infections and infestations Very common COVID-19a Common urinary tract infection, pneumoniab Uncommon sepsis Blood and lymphatic system disorders Very common anaemia, neutropeniac, leukopeniad Immune system disorders Uncommon anaphylactic reaction Metabolism and nutrition disorders Very common decreased appetite Nervous system disorders Common dysgeusia Eye disorders Very common dry eye, keratitise Common conjunctivitisf, lacrimation increased, keratopathyg, blepharitis, meibomian gland dysfunction, blurred vision, photophobia, visual impairmenth Respiratory, thoracic and mediastinal disorders Common ILD/pneumonitisi, dyspnoea, rhinorrhoea Gastrointestinal disorders Very common stomatitisj, nausea, constipation, vomiting, diarrhoea Common dry mouth Skin and subcutaneous tissue disorders Very common alopecia, rashk Common skin hyperpigmentationl, dry skinm, pruritus, madarosis General disorders and administration site conditions Very common fatiguen Investigations Very common aspartate aminotransferase increased, alanine aminotransferase increased Common amylase increasedo Injury, poisoning and procedural complications Common infusion-related reactionp a Including COVID-19, COVID-19 pneumonia, SARS-CoV-2 test positive. b Including pneumonia, lower respiratory tract infection and lower respiratory tract infection fungal. c Including neutropenia and neutrophil count decreased. d Including leukopenia and white blood cell count decreased. e Including keratitis, punctate keratitis and ulcerative keratitis. f Including conjunctivitis, conjunctival disorder, conjunctival hyperaemia and conjunctival irritation. g Including keratopathy, corneal epithelium defect, corneal lesion and injury corneal. h Including visual impairment and visual acuity reduced. i Including interstitial lung disease and pneumonitis. j Including stomatitis, aphthous ulcer, glossitis, mouth ulceration, odynophagia, oral pain, oropharyngeal pain and pharyngeal inflammation. k Including rash, erythematous rash, maculo-papular rash and pruritic rash.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.