Eucept

Monotherapy or in combination w/ MTX for moderate to severe active RA in adults when response to DMARDs including MTX has been inadequate; to reduce rate of progression of joint damage as measured by X-ray & to improve physical function. Monotherapy in case of intolerance to MTX or when continued treatment w/ MTX is inappropriate. Severe, active & progressive RA in adults not previously treated w/ MTX. 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. Enthesitis-related arthritis in adolescents from 12 yr who have had inadequate response to, or who have proved intolerant of conventional therapy. Adults w/ active & progressive psoriatic arthritis when response to previous DMARDs therapy has been inadequate; severe active ankylosing spondylitis who have had an inadequate response to conventional therapy; severe non-radiographic axial spondyloarthritis w/ objective signs of inflammation as indicated by elevated C-reactive protein &/or MRI evidence, who have had an inadequate response to NSAIDs; moderate to severe plaque psoriasis who failed to respond to, or contraindicated to, or intolerant to other systemic therapy including cyclosporin, MTX or PUVA light.

SC Administer in thigh, abdomen or upper arm, giving each new inj at least 3 cm from previous site. RA, psoriatic arthritis, ankylosing spondylitis & non-radiographic axial spondyloarthritis 25 mg twice wkly or 50 mg once wkly. Plaque psoriasis 25 mg twice wkly or 50 mg once wkly. Alternatively, may use 50 mg twice wkly for up to 12 wk followed by 25 mg twice wkly or 50 mg once wkly if necessary. Discontinue if no response after 12 wk. Re-treatment, intermittent therapy after initial treatment period: 25 mg twice wkly or 50 mg once wkly. JIA Ped patients weighing ≥62.5 kg 25 mg twice wkly or 50 mg once wkly. Discontinue if no response after 4 mth.

Hypersensitivity. Sepsis or risk of sepsis. Patients w/ active infections including chronic or localised infections or TB.

Allergic reactions including angioedema & urticaria. Not to inj in areas where skin is tender, bruised, red or hard. Discontinue treatment if serious allergic or anaphylactic reaction occurs; patient develops serious or HBV infection; blood dyscrasias are confirmed. Temporarily discontinue use in patients w/ significant exposure to varicella virus. Not to be initiated if active TB is diagnosed. Not to be used for treatment of alcoholic hepatitis. Not recommended for Wegener's granulomatosis. Possible risk for development of lymphomas, leukaemia or other haematopoietic or solid malignancies; increased of lymphoma & leukemia in RA patients w/ long standing, highly active, inflammatory disease. Serious infections, sepsis, TB & opportunistic infections including invasive fungal infections, listeriosis & legionellosis. Active TB including miliary TB & TB w/ extra-pulmonary location. Malignancies including breast & lung carcinoma & lymphoma; melanoma & non-melanoma skin cancer. Hypoglycemia in patients receiving medication for diabetes. Auto-Ab formation. Hepatitis B reactivation in patients w/ previous HBV infection & had received concomitant TNF-antagonists. Worsening of hepatitis C; CHF. Immunosuppression. History of recurring or chronic infections or w/ underlying conditions predisposing to infections eg, advanced or poorly controlled diabetes; HBV infection; hepatitis C; malignancy; blood dyscrasias. Patients w/ moderate to severe alcoholic hepatitis; CHF. Closely monitor patients who develop new infection while undergoing treatment. Evaluate patients for infections before, during & after treatment; both active & inactive (latent) TB before starting treatment; HBV infection before treatment initiation. Monitor signs & symptoms of active HBV infection during & several wk after discontinuation of therapy. Perform periodic skin exam in patients w/ risk factors for skin cancer; careful risk/benefit evaluation including neurological assessment in patients w/ pre-existing or recent onset of demyelinating disease, or to those w/ increased risk of developing demyelinating disease; FBC in patients who develop signs & symptoms suggestive of blood dyscrasias or infections while on therapy. Not recommended to use concomitantly w/ anakinra or abatacept. Not to be given concurrently w/ live vaccines. Women of childbearing potential should consider appropriate contraception during therapy & for 3 wk after discontinuation of therapy. Pregnancy & lactation. Not recommended to administer live vaccines to infants for 16 wk after mother's last dose. Elderly ≥65 yr (occurrence of infections).

Infection including URTI, bronchitis, cystitis, skin infection; headache; inj site reactions including bleeding, bruising, erythema, itching, pain & swelling. Auto-Ab formation; pruritus, rash; pyrexia. SJS, erythema multiforme, TEN.

Higher rate of serious infections & neutropenia w/ anakinra. Increased incidences of serious adverse events w/ abatacept. Decreased mean WBC 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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