Etarfion

Etanercept

Reduce signs & symptoms, induce major clinical response, inhibits structural damage progression, & improves physical function in patients w/ moderate to severe active RA, alone or in combination w/ MTX.

SC 25 mg twice wkly (50 mg/wk), 3-4 days apart.

Hypersensitivity. Not to be administered in patients w/ sepsis.

Immediately discontinue use if anaphylactic or serious allergic reaction occurs. Do not inj into areas where skin is tender, bruised, red or hard. Do not initiate treatment in patients w/ active infection, including clinically important localized infections. Greater risk of infection in patients >65 yr, w/ co-morbid conditions &/or taking concomitant immunosuppressants (eg, corticosteroids & MTX). Assess patients w/ chronic or recurrent infection; who have been exposed to TB; w/ history of opportunistic infection; who have resided or travelled in areas of endemic TB or mycoses eg, histoplasmosis, coccidioidomycosis, or blastomycosis; or w/ underlying conditions that may predispose to infection eg, advanced or poorly controlled diabetes prior to initiating therapy. Closely monitor signs & symptoms of infection during & after treatment; patients who develop a new infection while undergoing treatment. Discontinue use if patient develops serious infection or sepsis. Reactivation of TB or new TB infection. Evaluate for latent infection in patients at increased risk for TB before initiating & periodically during therapy; test for latent TB might be false -tive while on treatment. Patients w/ pre-existing or recent-onset peripheral or CNS demyelinating disorder. Possible malignancies eg, lymphoma, leukemia, melanoma & non-melanoma skin cancer (NMSC). Carefully monitor patients w/ heart failure. Monitor patients who develop signs & symptoms suggestive of blood dyscrasias or infections (eg, persistent fever, bruising, bleeding, or paleness) during treatment; discontinue use if significant hematologic abnormalities are confirmed. Evaluate patients at risk for HBV infection before initiating treatment for prior evidence of HBV infection. Monitor for clinical & lab signs of active HBV infection throughout therapy & several mth following termination. Discontinue treatment if patient develops symptoms & findings suggestive of lupus-like syndrome or autoimmune hepatitis; if HBV reactivation develops & initiate effective antiviral therapy w/ appropriate supportive treatment. Not recommended in combination w/ anakinra or abatacept. Moderate to severe alcoholic hepatitis. Pregnancy & lactation.

Viral, bacterial, & fungal infections, URTI, sinusitis & flu; erythema, itching, pain, swelling, bleeding, mild to moderate bruising; auto-Ab formation; diarrhea, rash, pruritus, pyrexia, urticaria, hypersensitivity; pancytopenia, anemia, leukopenia, neutropenia, thrombocytopenia, lymphadenopathy, aplastic anemia; CHF; inflammatory bowel disease; angioedema, chest pain; autoimmune hepatitis, elevated transaminases, hepatitis B reactivation; macrophage activation syndrome, systemic vasculitis, sarcoidosis; lupus-like syndrome; melanoma & NMSC, Merkel cell carcinoma; convulsions, multiple sclerosis, demyelination, optic neuritis, transverse myelitis, paresthesias; uveitis, scleritis; ILD; cutaneous lupus erythematosus, cutaneous vasculitis (including leukocytoclastic vasculitis), erythema multiforme, SJS, TEN, SC nodule, new or worsening psoriasis (all sub-types including pustular & palmoplantar), opportunistic infections, including atypical mycobacterial infection, herpes zoster, aspergillosis & Pneumocystis jiroveci pneumonia, & protozoal infections.

Not to be given concurrently w/ live vaccines & cyclophosphamide. Serious infections in concurrent treatment w/ anakinra. Increased incidences of serious adverse events w/ abatacept. Mild decrease in mean neutrophil counts w/ sulfasalazine.

Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

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

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