Enbrel

Etanercept

Reduction of signs & symptoms & inhibiting the progression of structural damage in patients w/ moderate to severe active RA as monotherapy or in combination w/ MTX. Reduction of signs & symptoms of active psoriatic arthritis in combination w/ MTX in patients who do not respond adequately to MTX alone. Reduction of signs & symptoms in patients w/ ankylosing spondylitis. Adults w/ severe non-radiographic axial spondyloarthritis w/ objective signs of inflammation who have had inadequate response to, or are intolerant to, conventional therapy. Adults ≥18 yr w/ chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Polyarticular-course juvenile idiopathic arthritis (JIA) in childn & adolescents from 2 yr proved to have inadequate response to ≥1 DMARDs. Polyarthritis (rheumatoid factor +ve or -ve) & extended oligoarthritis in childn & adolescents from 2 yr, & psoriatic arthritis in adolescents from 12 yr, who have had inadequate response to, or who have proved intolerant of, MTX. Psoriatic arthritis in adolescents ≥12 yr who have had an inadequate response to, or who have proved to be intolerant of MTX. Enthesitis-related arthritis in adolescents from 12 yr who have had inadequate response to, or who have proved intolerant of, conventional therapy. Chronic severe plaque psoriasis in childn & adolescents from 6 yr who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

SC Administer in the thigh, abdomen or upper arm. Administer new inj at least 3 cm from a previous site. RA, psoriatic arthritis, ankylosing spondylitis & non-radiographic axial spondyloarthritis Adult ≥18 yr 50 mg once wkly. Plaque psoriasis Adult 50 mg once wkly or 25 mg twice wkly (72-96 hr apart). Higher responses may be achieved from initial treatment w/ 50 mg twice wkly for up to 12 wk, followed by a dose of 50 mg once wkly or 25 mg twice wkly. Intermittent use: Treatment cycles subsequent to the initial cycle should use 50 mg once wkly or 25 mg twice wkly. Childn 6-17 yr 0.8 mg/kg once wkly (up to max 50 mg/dose) up to 24 wk. JIA Childn ≥2 yr to <18 yr 0.4 mg/kg (up to max 25 mg/dose) twice wkly (72-96 hr apart), or 0.8 mg/kg (up to a max of 50 mg/dose) once wkly. Ped plaque psoriasis Childn ≥6 yr to <18 yr 0.8 mg/kg (up to a max of 50 mg/dose) once wkly for up to 24 wk. Re-treatment: 0.8 mg/kg (up to a max of 50 mg/dose) once wkly.

Hypersensitivity. Sepsis or risk of sepsis. Serious active infection including chronic or localized infections.

Discontinue treatment in serious allergic or anaphylactic reactions, if patient develops serious infection & in confirmed blood dyscrasias. Closely monitor patients who develop new infection while undergoing treatment. Patients w/ history of recurring or chronic infections or w/ underlying conditions which may predispose patients to infections. Evaluate patients for infections before, during & after treatment; for active or latent TB infection; for prior evidence of HBV infection. May worsen hepatitis C. Opportunistic infections including invasive fungal infections. Not recommended to be concomitantly used w/ anakinra & abatacept. Not recommended for patients w/ Wegener's granulomatosis & alcoholic hepatitis. Immunosuppression. Auto-Ab formation. Patients w/ CHF & those receiving diabetes medication. Increased risk for lymphoma & leukemia in RA patients, & development of lymphomas or other hematopoietic or solid malignancies. Perform periodic skin exam in patients w/ increased risk for skin cancer. Previous history of blood dyscrasias. Not to be given concurrently w/ live vaccines. Perform careful risk/benefit evaluation including neurological assessment in patients w/ preexisting or recent onset of demyelinating disease, or to those w/ increased risk of developing demyelinating disease. Reactivation of latent TB infection or to new infection. Initiate prophylaxis of latent TB infection prior to therapy. Hepatitis B reactivation. Inflammatory bowel disease in patients w/ JIA. Pregnancy & lactation. Childn <2 yr.

URTI, bronchitis, cystitis, skin infection; inj site reactions including bleeding, bruising, erythema, itching, pain, & swelling. Allergic reactions, pruritus, rash, Ab formation; pyrexia.

Concurrent treatment w/ anakinra may result to higher rate of serious infection. Increased incidences of serious adverse events w/ abatacept. Decreased mean WBC counts w/ sulfasalazine.

Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants

L04AB01 - etanercept ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.

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