Enbrel - Indications & Dosage

[etanercept]

INDICATIONS AND USAGE

ENBREL® is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. ENBREL® can be initiated in combination with methotrexate (MTX) or used alone.

ENBREL® is indicated for reducing signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to one or more DMARDs.

ENBREL® is indicated for reducing signs and symptoms and inhibiting the progression of structural damage of active arthritis in patients with psoriatic arthritis. ENBREL® can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. ENBREL® is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.




ENBREL® is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

DOSAGE AND ADMINISTRATION

Adult RA, AS, and Psoriatic Arthritis Patients

The recommended dose of ENBREL® for adult patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis is 50 mg per week given as one subcutaneous (SC) injection using a 50 mg/mL single-use prefilled syringe. Methotrexate, glucocorticoids, salicylates,nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with ENBREL®. Based on a study of 50 mg ENBREL® twice weekly in patients with RA that suggested higher incidence of adverse reactions but similar ACR response rates, doses higher than50 mg per week are not recommended (see ADVERSE REACTIONS).

Adult Plaque Psoriasis Patients

The recommended starting dose of ENBREL® for adult patients is a 50 mg dose given twice weekly (administered 3 or 4 days apart) for 3 months followed by a reduction to a maintenance dose of 50 mg per week (see CLINICAL STUDIES). The recommended dose should be administered subcutaneously, using 50 mg/mL single-use prefilled syringes.Starting doses of ENBREL®of 25 mg or 50 mg per week were also shown to be efficacious. The proportion of responders were related to ENBREL® dosage (see CLINICAL STUDIES).


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