Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Padcev

Padcev 20 mg powder for concentrate for solution for infusion Padcev 30 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 12–13

HOS-147172 · Präparat HOS-099602

12 Frequency Monotherapy In combination with pembrolizumab Skin and subcutaneous tissue disorders Alopecia, pruritus, rash, rash Alopecia, pruritus, rash, rash Very common maculo-papular, dry skin maculo-papular, dry skin Drug eruption, skin exfoliation, Skin exfoliation, conjunctivitis, conjunctivitis, dermatitis bullous, dermatitis exfoliative generalised, blister, stomatitis, palmar-plantar dermatitis bullous, blister, stomatitis, erythrodysesthesia syndrome, eczema, palmar-plantar erythrodysesthesia Common erythaema, rash erythaematous, rash syndrome, eczema, erythaema, rash macular, rash papular, rash pruritic, erythaematous, rash macular, rash rash vesicular papular, rash pruritic, rash vesicular, dermatitis Dermatitis exfoliative generalised, Drug eruption, erythaema erythaema multiforme, exfoliative multiforme, exfoliative rash, rash, pemphigoid, rash pemphigoid, dermatitis allergic, Uncommon maculovesicular, dermatitis, dermatitis contact, intertrigo, skin dermatitis allergic, dermatitis contact, irritation, stasis dermatitis intertrigo, skin irritation, stasis dermatitis, blood blister Toxic epidermal necrolysis, skin Toxic epidermal necrolysis, skin hyperpigmentation, skin hyperpigmentation, skin discolouration, pigmentation disorder, discolouration, pigmentation Stevens-Johnson syndrome, disorder, Stevens-Johnson Not known1 epidermal necrosis, symmetrical syndrome, epidermal necrosis, drug-related intertriginous and symmetrical drug-related flexural exanthaema intertriginous and flexural exanthaema Musculoskeletal and connective tissue disorders Uncommon Myositis General disorders and administration site conditions Very common Fatigue Fatigue Common Infusion site extravasation Infusion site extravasation Investigations Alanine aminotransferase increased, Alanine aminotransferase increased, Very common aspartate aminotransferase increased, aspartate aminotransferase increased, weight decreased weight decreased Common Lipase increased Injury, poisoning and procedural complications Common Infusion related reaction Infusion related reaction 1 Based on global post-marketing experience. 2 Includes: acute respiratory distress syndrome, autoimmune lung disease, immune-mediated lung disease, interstitial lung disease, lung opacity, organising pneumonia, pneumonitis, pulmonary fibrosis, pulmonary toxicity, pulmonary sarcoidosis and sarcoidosis.

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