Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Bavencio

Bavencio 20 mg/mL concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 11–12

HOS-138025 · Präparat HOS-098135

11  Frequency Adverse reactions Gastrointestinal disorders Very common Nausea, diarrhoea, constipation, vomiting, abdominal pain Common Dry mouth Uncommon Ileus, colitis* Rare Pancreatitis*, autoimmune colitis*, enterocolitis*, autoimmune pancreatitis*, enteritis*, proctitis* Not known Gastritis* Hepatobiliary disorders Uncommon Autoimmune hepatitis* Rare Acute hepatic failure*, hepatic failure*, hepatitis*, hepatotoxicity* Not known Sclerosing cholangitis* Skin and subcutaneous tissue disorders Common Pruritus*, rash*, dry skin, rash maculo-papular* Uncommon Eczema, dermatitis, rash pruritic*, psoriasis*, erythema*, rash erythematous*, rash generalised*, rash macular*, rash papular* Rare Erythema multiforme*, purpura*, vitiligo*, pruritus generalised*, dermatitis exfoliative*, pemphigoid*, dermatitis psoriasiform*, drug eruption*, lichen planus* Musculoskeletal and connective tissue disorders Very common Back pain, arthralgia Common Myalgia Uncommon Myositis*,ϕ, rheumatoid arthritis* Rare Arthritis*, polyarthritis*, oligoarthritis*, Sjogren’s syndrome* Not known Polymyalgia rheumatica* Renal and urinary disorders Uncommon Renal failure*, nephritis* Rare Tubulo-interstitial nephritis*, cystitis noninfective* General disorders and administrative site conditions Very common Fatigue, pyrexia, oedema peripheral Common Asthenia, chills, influenza like illness Rare Systemic inflammatory response syndrome* Investigations Very common Weight decreased Common Blood creatinine increased, blood alkaline phosphatase increased, lipase increased, gamma-glutamyltransferase increased, amylase increased Uncommon Alanine aminotransferase (ALT) increased*, aspartate aminotransferase (AST) increased*, blood creatine phosphokinase increased* Rare Transaminases increased*, thyroxine free decreased*, blood thyroid stimulating hormone increased* * Immune-mediated adverse reaction based on medical review § Reaction only observed from study EMR 100070-003 (Part B) after the data cut-off of the pooled analysis, hence frequency estimated # Including cytokine release syndrome with frequency uncommon † Adverse reactions occurred in estimated 4 000 patients exposed to avelumab monotherapy beyond the pooled analysis ϕ Can occur simultaneously (see section 4.4)

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