Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Keytruda

KEYTRUDA 395 mg solution for injection KEYTRUDA 790 mg solution for injection · Abschnitt 4.8 · PDF-Seite 180–181

HOS-131863 · Präparat HOS-097138

180 • gastritis (gastritis erosive, gastritis haemorrhagic and immune-mediated gastritis) • pancreatitis (autoimmune pancreatitis, pancreatitis acute and immune-mediated pancreatitis) • gastrointestinal ulceration (gastric ulcer and duodenal ulcer) • hepatitis (autoimmune hepatitis, immune-mediated hepatitis, drug induced liver injury and acute hepatitis) • cholangitis sclerosing (immune-mediated cholangitis) • pruritus (urticaria, urticaria papular and pruritus genital) • rash (rash erythematous, rash follicular, rash macular, rash maculo-papular, rash papular, rash pruritic, rash vesicular and genital rash) • severe skin reactions (exfoliative rash, pemphigus, and Grade ≥ 3 of the following: cutaneous vasculitis, dermatitis bullous, dermatitis exfoliative, dermatitis exfoliative generalised, erythema multiforme, lichen planus, oral lichen planus, pemphigoid, pruritus, pruritus genital, rash, rash erythematous, rash maculo-papular, rash pruritic, rash pustular, skin necrosis and toxic skin eruption) • vitiligo (skin depigmentation, skin hypopigmentation and hypopigmentation of the eyelid) • lichenoid keratosis (lichen planus and lichen sclerosus) • musculoskeletal pain (musculoskeletal discomfort, back pain, musculoskeletal stiffness, musculoskeletal chest pain and torticollis) • myositis (myalgia, myopathy, necrotising myositis, polymyalgia rheumatica and rhabdomyolysis) • arthritis (joint swelling, polyarthritis, joint effusion, autoimmune arthritis and immune-mediated arthritis) • tenosynovitis (tendonitis, synovitis and tendon pain) • nephritis (autoimmune nephritis, immune-mediated nephritis, tubulointerstitial nephritis, renal failure, renal failure acute, or acute kidney injury with evidence of nephritis, nephrotic syndrome, glomerulonephritis, glomerulonephritis membranous and glomerulonephritis acute) • oedema (oedema peripheral, generalised oedema, fluid overload, fluid retention, eyelid oedema, lip oedema, face oedema, localised oedema and periorbital oedema)

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