*see Description of selected adverse reactions, below.
Description of selected adverse reactions 13 System Organ Class Very Common ≥ 1/10 Common ≥ 1/100 to Uncommon ≥ 1/1,000 to Rare ≥ 1/10,000 to Very Rare Not Known (Cannot be Estimated from Available Data) demyelinating polyneuropathy, and multifocal motor neuropathy (see section 4.4), seizure Eye disorders Uveitis, scleritis Cardiac disorders Worsening of cardiac failure congestive (see section 4.4) New onset cardiac failure congestive (see section 4.4) Respiratory, thoracic, and mediastinal disorders Interstitial lung disease (including pneumonitis and pulmonary fibrosis)* Gastrointestinal disorders Inflammatory bowel disease Hepatobiliary disorders Elevated liver enzymes* Autoimmune hepatitis* Skin and subcutaneous tissue disorders Pruritus, rash Angioedema, psoriasis (including new onset or worsening and pustular, primarily palms and soles), urticaria, psoriasiform rash Stevens-Johnson syndrome, cutaneous vasculitis (including hypersensitivity vasculitis), erythema multiforme, lichenoid reactions Toxic epidermal necrolysis Musculoskeletal and connective tissue disorders Cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus, lupus-like syndrome Renal and urinary disorders Glomerulonephri tis General disorders and administration site conditions Injection site reactions (including bleeding, bruising, erythema, itching, pain, swelling)* Pyrexia