Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Bavencio

Bavencio 20 mg/mL concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 13–14

HOS-138032 · Präparat HOS-098135

13  Frequency Adverse reactions Hepatobiliary disorders Common Hepatic function abnormal* Uncommon Hepatitis*, hepatotoxicity*, immune-mediated hepatitis*, liver disorder* Not known Sclerosing cholangitis* Skin and subcutaneous tissue disorders Very common Rash*, pruritus* Common Rash pruritic*, rash maculo-papular*, pruritus generalized*, dermatitis acneiform, erythema*, rash macular*, rash papular*, rash erythematous*, dermatitis*, eczema, rash generalized* Uncommon Drug eruption*, erythema multiforme*, psoriasis* Musculoskeletal and connective tissue disorders Very common Arthralgia, back pain, myalgia Uncommon Arthritis* Not known Polymyalgia rheumatica*, Sjogren’s syndrome* Renal and urinary disorders Common Acute kidney injury* General disorders and administrative site conditions Very common Fatigue, chills, asthenia, pyrexia Common Oedema peripheral, influenza like illness Investigations Very common Weight decreased, alanine aminotransferase (ALT) increased*, aspartate aminotransferase (AST) increased* Common Blood creatinine increased, amylase increased, lipase increased, gamma-glutamyltransferase increased, blood alkaline phosphatase increased, blood creatine phosphokinase increased*, blood thyroid stimulating hormone decreased*, transaminases increased* Uncommon Liver function test increased* * Immune-mediated adverse reaction based on medical review # Including cytokine release syndrome with frequency not known

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