Enbrel

Etanercept

Signs & symptoms, & inhibiting the structural damage progression in adults w/ moderately to severely active RA as monotherapy or in combination w/ MTX in patients w/ inadequate response to MTX alone. Polyarthritis (rheumatoid factor +ve or -ve) & extended oligoarthritis in childn & adolescents from 2 yr who have had an inadequate response to or who have proved intolerant of MTX. Psoriatic arthritis in adolescents from 12 yr who have had an inadequate response to or who have proved intolerant of MTX. Enthesitis-related arthritis in adolescents from 12 yr who have had an inadequate response to or who have proved intolerant of conventional therapy. Reduction of signs & symptoms of active arthritis in adults w/ psoriatic arthritis as monotherapy or in combination w/ MTX in patients w/ inadequate response to MTX alone. Signs & symptoms of active ankylosing spondylitis in adults w/ inadequate response to conventional therapy. Severe non-radiographic axial spondyloarthritis w/ objective inflammation signs (elevated CRP &/or MRI evidence) in adults who have had an inadequate response to NSAIDs. Adults w/ moderate to severe chronic plaque psoriasis who are unresponsive, w/ CI to, or intolerant to other systemic therapy including cyclosporine, MTX or PUVA. Chronic severe plaque psoriasis in childn & adolescent from 6 yr who are inadequately controlled by or intolerant to other systemic therapies or phototherapies.

SC Adult 18-64 yr & elderly (≥65 yr) RA, psoriatic arthritis, ankylosing spondylitis & non-radiographic axial spondyloarthritis 25 mg twice wkly (72-96 hr apart) or 50 mg once wkly. Plaque psoriasis 25 mg twice wkly (72-96 hr apart) or 50 mg once wkly. Alternatively, 50 mg twice wkly for up to 12 wk, followed by 25 mg twice wkly or 50 mg once wkly if necessary. May be used for up to 24 wk. Childn Individualized dosage based on body wt. Juvenile idiopathic arthritis 0.4 mg/kg (max: 25 mg/dose) twice wkly (72-96 hr apart) w/ 3-4 days interval between doses or 0.8 mg/kg (max: 50 mg/dose) once wkly. ≥6 yr Plaque psoriasis 0.8 mg/kg (max: 50 mg/dose) once wkly for up to 24 wk.

Hypersensitivity. Active TB or other severe infections (eg, sepsis, abscesses & opportunistic infections).

Immediately discontinue use if any serious allergic or anaphylactic reaction occurs. Closely monitor patients who develop a new infection while undergoing treatment. Discontinue if a serious infection (including sepsis & TB) develops. Patients w/ history of recurring or chronic infections or w/ underlying conditions which may predispose to infections. Evaluate infections before, during & after treatment. Concomitant use w/ immunosuppressants. Consider the patient's risk for relevant opportunistic infections (eg, exposure to endemic mycoses). Evaluate active or latent infection in patients at increased risk for TB before initiation of therapy. Monitor for signs & symptoms of active TB including patients tested -ve for latent TB infection. Possible hepatitis B reactivation in patients w/ previous HBV infection & had received concomitant anti-TNF agents. Evaluate patients at high risk for HBV infection before treatment initiation for prior evidence of HBV infection. Monitor for signs & symptoms of active HBV infection throughout therapy & for several mth following termination. Discontinue treatment if HBV reactivation develops & initiate appropriate supportive treatment. Worsening of hepatitis C. Concurrent treatment w/ anakinra & abatacept. Not recommended for Wegener's granulomatosis. Patients w/ immunosuppression or chronic infections. Temporarily discontinue therapy in patients w/ significant exposure to varicella virus; consider prophylactic treatment w/ varicella zoster immune globulin. Possible risk for development of lymphomas or other haematopoietic or solid malignancies in patients treated w/ TNF-antagonist. Possible malignancies particularly Hodgkin's & non-Hodgkin's lymphomas; some fatal among childn & adolescents. Perform periodic skin exam in patients at increased risk for skin cancer. History of blood dyscrasias. Monitor & investigate patients who develop signs & symptoms suggestive of blood dyscrasias or infections (eg, persistent fever, sore throat, bruising, bleeding, paleness) during treatment; discontinue if blood dyscrasias are confirmed. May be associated w/ autoimmune Ab formation. Live vaccines should not be given concurrently. Careful risk/benefit evaluation including a neurological assessment in patients w/ pre-existing or recent onset of demyelinating disease. Worsening of CHF w/ & w/o identifiable precipitating factors. Hypoglycemia in patients treated for diabetes. Long-term combination w/ DMARDs. Moderate to severe alcoholic hepatitis. Combination w/ other immunosuppressants or phototherapy for psoriasis. Women of child-bearing potential should be advised not to get pregnant during therapy. Not recommended during pregnancy. Lactation. Consider administration of live vaccines to a breastfed infant 16 wk after breastfeeding discontinuation (or earlier if etanercept serum levels are undetectable in the infant). Childn <2 yr (juvenile idiopathic arthritis); <6 yr (paed plaque psoriasis).

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

Increased incidences of serious adverse events w/ abatacept. Not to be administered in combination w/ MTX for psoriasis. Higher rate of serious infections & neutropenia w/ anakinra. Statistically significant decreased in mean WBC counts w/ sulfasalazine. Not to be given concurrently w/ live vaccines.

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

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

POM