Etarfion Adverse Reactions

Infections: viral, bacterial, and fungal infections, upper respiratory tract infection, sinusitis, and influenza.
Injection site reactions: erythema, itching, pain, swelling, bleeding, bruising (mild to moderate).
Immunogenicity: antibodies to the TNF-receptor portion or other protein components.
Patients with RA were tested at multiple time points for antibodies to Etanercept. Antibodies to the TNF-receptor portion or other protein components of Etanercept drug product were detected at least once in the sera of approximately 6% of RA patients. These antibodies were all non-neutralizing.
The percentage of patients tested positive increased with an increase in the duration of the study; however, the clinical significance of this finding is unknown.
No apparent correlation of antibody development to clinical response or adverse events was observed.
The long-term immunogenicity data of Etanercept beyond 120 weeks of exposure are unknown.
The data reflect the percentage of patients whose test results were considered positive for antibodies to Etanercept in an ELISA assay, and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of any antibody positivity in an assay is highly dependent on several factors including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications and underlying disease. For these reasons, comparison of the incidence of antibodies to Etanercept with the incidence of antibodies to other products may be misleading.
Autoantibodies: antinuclear antibodies (ANA), anti-double-stranded DNA.
Other adverse reactions: diarrhea, rash, pruritus, pyrexia, urticaria, hypersensitivity.
Blood and lymphatic system disorders: pancytopenia, anemia, leukopenia, neutropenia, thrombocytopenia, lymphadenopathy, aplastic anemia.
Cardiac disorders: congestive heart failure.
Gastrointestinal disorders: inflammatory bowel disease (IBD).
General disorders: angioedema, chest pain.
Hepatobiliary disorders: autoimmune hepatitis, elevated transaminases, hepatitis B reactivation.
Immune disorders: macrophage activation syndrome, systemic vasculitis, sarcoidosis.
Musculoskeletal and connective tissue disorders: Lupus-like syndrome.
Neoplasms benign, malignant, and unspecified: melanoma and non-melanoma skin cancers, Merkel cell carcinoma.
Nervous system disorders: convulsions, multiple sclerosis, demyelination, optic neuritis, transverse myelitis, paresthesias.
Ocular disorders: uveitis, scleritis.
Respiratory, thoracic, and mediastinal disorders: interstitial lung disease.
Skin and subcutaneous tissue disorders: cutaneous lupus erythematosus, cutaneous vasculitis (including leukocytoclastic vasculitis), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, subcutaneous nodule, new or worsening psoriasis (all sub-types including pustular and palmoplantar).
Opportunistic infections, including atypical mycobacterial infection, herpes zoster, aspergillosis and Pneumocystis jiroveci pneumonia, and protozoal infections.