Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Amgevita

AMGEVITA 20 mg solution for injection in pre-filled syringe AMGEVITA 40 mg solution for injection in pre-filled syringe AMGEVITA 80 mg solution for injection in pre-filled syringe AMGEVITA 40 mg solution for injection in pre-filled pen AMGEVITA 80 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 73–74

HOS-224942 · Präparat HOS-217372

73 System organ class Frequency Adverse reactions Skin and subcutaneous Very common Rash (including exfoliative rash) tissue disorders Common Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis)1), Urticaria, Bruising (including purpura), Dermatitis (including eczema), Onychoclasis, Hyperhidrosis, Alopecia1), Pruritus Uncommon Night sweats, Scar Rare Erythema multiforme1), Stevens-Johnson syndrome1), Angioedema1), Cutaneous vasculitis1), Lichenoid skin reaction1) Not known Worsening of symptoms of dermatomyositis1) Musculoskeletal and Very common Musculoskeletal pain connective tissue Common Muscle spasms (including blood creatine phosphokinase disorders increased) Uncommon Rhabdomyolysis, Systemic lupus erythematosus Rare Lupus-like syndrome1) Renal and urinary Common Renal impairment, disorders Haematuria Uncommon Nocturia Reproductive system Uncommon Erectile dysfunction and breast disorders General disorders and Very common Injection site reaction (including injection site erythema) administration site Common Chest pain, conditions* Oedema, Pyrexia1) Uncommon Inflammation Investigations* Common Coagulation and bleeding disorders (including activated partial thromboplastin time prolonged), Autoantibody test positive (including double stranded DNA antibody), Blood lactate dehydrogenase increased Not known Weight increased2) Injury, poisoning and Common Impaired healing procedural complications * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open-label extension studies 1) Including spontaneous reporting data. 2) The mean weight change from baseline for adalimumab ranged from 0.3 kg to 1.0 kg across adult indications compared to (minus) -0.4 kg to 0.4 kg for placebo over a treatment period of 4-6 months. Weight increase of 5-6 kg has also been observed in long-term extension studies with mean exposures of approximately 1-2 years without control group, particularly in patients with Crohn’s disease and ulcerative colitis. The mechanism behind this effect is unclear but could be associated with the anti-inflammatory effect of adalimumab.

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