Clinical Pharmacology Details


Etanercept


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Indications & Dose:

Moderate to severe active rheumatoid arthritis (aloneor in combination withme thotrexate) whentheresponseto other disease -modifying antirheumatic drugsis inadequate |Severe, active, and progressive rheumatoid arthritis not previously treated with methotrexate | Active and progressive psoriaticarthritis in adequately responsive to other disease-modifying antirheumatic drugs | Severe ankylosing spondylitis in adequately responsive to conventional therapy



Adult: 25mgtwiceweekly,alternatively 50mg once weekly Severe plaque psoriasiseither refractory to atleast 2 standard systemic treatments and photochemotherapy,  or when standard treatment scan not be used because of intolerance or contraindications



Adult: 25mg twice weekly for up to 24 weeks, alternatively 50mg once weekly for up to 24 weeks, discontinue if no response after 12 weeks

Contraindications:

Should not be administered to patients with sepsis

Side Effects:

Upper Respiratory Infectionse, Non-upper Respiratory Infections, Injection Site Reactions, Diarrhea, Rash, Pruritus, Pyrexia, Urticaria, Hypersensitivity

Cautions:

Precautions:

Serious Infections, Tuberculosis, Invasive Fungal Infections, Neurologic Events, Malignancies, Lymphomas, Leukemia, Other Malignancies, Melanoma and Non-melanoma skin cancer (NMSC), Pediatric Patients, Patients With Heart Failure, Hematologic Events, Hepatitis B Virus Reactivation, Allergic Reactions, Immunizations, Autoimmunity, Immunosuppression, Use in Wegener’s Granulomatosis Patients. 

Interaction:

Vaccines, Immune-Modulating Biologic Products, Cyclophosphamide, Sulfasalazine 

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Blood and lymphatic systemdisorders: 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


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. 

Patient And Carer Advice: