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Etanercept

Immunosuppressant Prescription
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Indications

Rheumatoid Arthritis Psoriasis

Etanercept is used in adults with rheumatoid arthritis (RA) to reduce signs and symptoms, induce a major clinical response, inhibit the progression of structural damage and improve physical function. This applies to moderately to severely active RA. It can be started in combination with methotrexate (MTX) or used alone for active RA in adults when one or more disease modifying antirheumatic drugs (DMARDs), including methotrexate (unless contraindicated), have proved inadequate. Pediatric patients with juvenile idiopathic arthritis (JIA): Etanercept is used for polyarticular-course JIA in children and adolescents from the age of 2 years, when the response to one or more DMARDs has proven inadequate. Adults with psoriatic arthritis (PsA): Etanercept is used to reduce signs and symptoms, inhibit the progression of structural damage of active arthritis and improve physical function. It can be combined with methotrexate (MTX) in patients who do not respond adequately to MTX alone. Adults with ankylosing spondylitis (AS): Shieldexis is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS). Adults with plaque psoriasis (PsO): Etanercept is used for adult patients (18 years or older) with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. Pediatric patients with plaque psoriasis (PsO): Etanercept is used for chronic severe plaque psoriasis in children and adolescents from the age of 6 years, who are inadequately controlled by, or are intolerant to, systemic therapies or phototherapies.

⚠️ Always consult a registered physician before taking any medicine.

Pharmacology

Etanercept is a tumor necrosis factor (TNF) blocker. It is a dimeric fusion protein, made by linking the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) to the Fc portion of human IgG1. The Fc part of etanercept has the CH2 domain, the CH3 domain and the hinge region, but not the CH1 domain of IgG1. It is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons.

Etanercept is a TNF alpha inhibitor. It binds specifically to tumor necrosis factor (TNF) and stops it from interacting with the TNF receptors on the cell surface. TNF is a cytokine that occurs naturally in the body and takes part in normal inflammatory and immune responses. Raised levels of TNF are found in the synovial fluid of RA patients. TNF also plays an important role in the inflammatory processes of rheumatoid arthritis (RA), polyarticular-course juvenile rheumatoid arthritis (JRA) and the joint damage that follows.

Pregnancy & Breastfeeding

Nobody has established that etanercept is safe to use in pregnancy, so it should be used during pregnancy only if it is clearly needed. The same is true for breastfeeding, where its safety has also not been established.

We don't know whether etanercept passes into human milk. In lactating rats given etanercept under the skin, it did appear in the milk and was found in the blood serum of the pups. Immunoglobulins and many other medicines can pass into human milk, so a decision has to be made: either stop nursing, or stop etanercept while nursing.

⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.

Dosage Reference

⚠️ Reference ranges from official sources only. Consult your doctor for personalized dosing.

Adults: Dosage Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis For patients aged 18 years or older, the dose of Etanercept is 50 mg per week, given as a subcutaneous injection. This can be one 50 mg injection once weekly (using a 50 mg syringe, or as two 25 mg injections given at the same time). The other option is 25 mg twice weekly, with the injections 72 to 96 hours apart. In adults, methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics may be continued during treatment with Etanercept. A dose of 25 mg once weekly gives a slower response and may be less effective. Plaque psoriasis The dose of etanercept is 50 mg once weekly, given as a subcutaneous injection (one injection using a 50 mg syringe, or two 25 mg injections given at approximately the same time). Another option is 25 mg twice weekly, 72 to 96 hours apart, also by subcutaneous injection. A higher response may be reached by starting with 50 mg twice weekly for up to 12 weeks. After that, if necessary, the dose is 50 mg once weekly or 25 mg twice weekly. Adults may be treated intermittently or continuously, depending on the physician's judgment and what the individual patient needs. Treatment should be stopped in patients who show no response after 12 weeks. With intermittent use, later treatment cycles after the first one should use 50 mg once weekly. No dose adjustment is required for elderly patients or for patients with renal and hepatic impairment. A patient who weighs less than 62.5 kg should be dosed accurately on an mg/kg basis. Patients weighing 62.5 kg or more may use the fixed-dose prefilled syringe. Juvenile idiopathic arthritis For children aged 2 to under 18 years, the dose is 0.4 mg/kg (up to a maximum of 25 mg per dose) twice weekly, 72 to 96 hours apart. Glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics may be continued during treatment with etanercept in children. Etanercept has not been studied in children under 2 years of age. Pediatric plaque psoriasis For children aged 6 to under 18 years, the dose is 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly for up to 24 weeks. Treatment should be stopped in patients who show no response after 12 weeks. If etanercept needs to be given again, the same guidance on treatment duration applies, and the dose should be 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly.