Etveza 25 Adverse Reactions

Summary of the safety profile: The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such as upper respiratory infections, bronchitis, bladder infections and skin infections), allergic reactions, development of autoantibodies, itching, and fever.
Serious adverse reactions have also been reported for Etanercept. TNF-antagonists, such as Etanercept, affect the immune system and their use may affect the body's defenses against infection and cancer. Serious infections affect fewer than 1 in 100 patients treated with Etanercept. Reports have included fatal and life-threatening infections and sepsis. Various malignancies have also been reported with use of Etanercept, including cancers of the breast, lung, skin and lymph glands (lymphoma).
Serious haematological, neurological and autoimmune reactions have also been reported. These include rare reports of pancytopenia and very rare reports of aplastic anaemia. Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with Etanercept use. There have been rare reports of lupus, lupus-related conditions, and vasculitis.
Tabulated list of adverse reactions: The following list of adverse reactions is based on experience from clinical trials in adults and on postmarketing experience.
Within the organ system classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Infections and infestations: Very common: Infections (including upper respiratory tract infections, bronchitis, cystitis, skin infections).
Uncommon: Serious infections (including pneumonia, cellulitis, septic arthritis, sepsis and parasitic infection).
Rare: Tuberculosis, opportunistic infections (including invasive fungal, protozoal, bacterial, atypical mycobacterial, viral infections, and Legionella).
Not known: Listeria, hepatitis B reactivation.
Neoplasms benign, malignant and unspecified (including cysts and polyps): Uncommon: Non-melanoma skin cancers.
Rare: Lymphoma, melanoma.
Not known: Leukaemia, Merkell cell carcinoma.
Blood and lymphatic system disorders: Uncommon: Thrombocytopenia.
Rare: Anaemia, leukopenia, neutropenia, pancytopenia.
Very rare: Aplastic anaemia.
Immune system disorders: Common: Allergic reactions (see Skin and subcutaneous tissue disorders as follows), autoantibody formation*.
Uncommon: Systemic vasculitis (including anti-neutrophilic cytoplasmic antibody positive vasculitis).
Rare: Serious allergic/anaphylactic reactions (including angioedema, bronchospasm), sarcoidosis.
Not known: Macrophage activation syndrome, worsening of symptoms of dermatomyositis.
Nervous system disorders: Rare: Seizures, CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis.
Very rare: Peripheral demyelinating events, including Gullain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy.
Eye disorders: Uncommon: Uveitis, scleritis.
Cardiac disorders: Rare: Congestive heart failure.
Respiratory, thoracic and mediastinal disorders: Uncommon: Interstitial lung disease (including pneumonitis and pulmonary fibrosis).
Hepatobiliary disorders: Rare: Elevated liver enzymes, autoimmune hepatitis.
Skin and subcutaneous tissue disorders: Common: Pruritus.
Uncommon: Angioedema, urticaria, rash, psoriasiform rash, psoriasis (including new onset or worsening and pustular, primarily palms and soles).
Rare: Cutaneous vasculitis (including leukocytoclastic vasculitis), Stevens-Johnson syndrome, erythema multiforme.
Very rare: Toxic epidermal necrolysis.
Musculoskeletal and connective tissue disorders: Rare: Subacute cutaneous lupus erythematosus, discoid lupus erythematosus, lupus-like syndrome.
General disorders and administration site conditions: Very common: Injection site reactions (including bleeding, bruising, erythema, itching, pain, swelling).
Common: Fever.