Etanercept


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : SC Ankylosing spondylitis; Rheumatoid arthritis; Psoriatic arthritis 25 mg twice wkly at 3-4 days interval or 50 mg once wkly. Chronic moderate to severe plaque psoriasis Initial: 25 mg twice wkly or 50 mg once wkly. Alternatively, 50 mg twice wkly at 3-4 days interval for up to 12 wk, then 25 mg twice wkly or 50 mg once wkly.
Dosage Details
Subcutaneous
Chronic moderate to severe plaque psoriasis
Adult: Initially, 25 mg twice wkly or 50 mg once wkly. Alternatively, 50 mg twice wkly at intervals of 3-4 days for up to 12 wk, then reduce to 25 mg twice wkly or 50 mg once wkly. Continue treatment until remission is achieved, up to 24 wk. Discontinue if no response after 12 wk.
Child: Chronic severe plaque psoriasis: ≥6 yr 0.8 mg/kg once wkly for up to 24 wk. Max: 50 mg wkly. Discontinue if no response after 12 wk.

Subcutaneous
Juvenile idiopathic arthritis
Child: ≥2 yr 0.4 mg/kg (max: 25 mg) twice wkly at intervals of 3-4 days, or alternatively, 0.8 mg/kg (max: 50 mg) once wkly. Discontinue treatment if no response after 6 mth or initial response is not maintained.

Subcutaneous
Ankylosing spondylitis, Rheumatoid arthritis
Adult: 25 mg twice wkly at intervals of 3-4 days or 50 mg once wkly. Discontinue treatment if no response after 6 mth for rheumatoid arthritis, and after 12 wk for ankylosing spondylitis.

Subcutaneous
Psoriatic arthritis
Adult: 25 mg twice wkly at intervals of 3-4 days or 50 mg once wkly. Discontinue treatment if no response after 12 wk.
Child: ≥12 yr 0.4 mg/kg (max: 25 mg) twice wkly at intervals of 3-4 days, or alternatively, 0.8 mg/kg (max: 50 mg) once wkly. Discontinue treatment if no response after 6 mth or initial response is not maintained.
Reconstitution
Slowly add 1 mL of bacteriostatic water for inj (containing benzyl alcohol 0.9%) then swirl gently to avoid foaming. Do not shake the vial.
Contraindications
Sepsis or risk of sepsis; active infections including chronic or localised infections.
Special Precautions
Patient w/ history of recurring or chronic infections or w/ underlying conditions that may predispose patient to infections (e.g. advanced or poorly controlled DM); previous hepatitis B virus infection; history of hepatitis C, blood dyscrasias; pre-existing or recent onset of demyelinating disease; CHF, moderate to severe alcoholic hepatitis. Childn. Pregnancy and lactation.
Adverse Reactions
Nausea, vomiting, dyspepsia, headache, dizziness, asthenia, allergic reactions, development of autoantibodies, fever; mild to moderate inj site reactions (e.g. erythema, itching, pain, swelling).
Potentially Fatal: Serious infections and sepsis (e.g. TB, invasive fungal infections), malignancies (e.g. breast, lung and skin cancers; lymphoma). Rarely, pancytopenia, aplastic anaemia, central and peripheral demyelinating events, lupus, lupus-related conditions and vasculitis; anaphylaxis.
MonitoringParameters
Monitor CBC w/ differential; signs/symptoms of infection (prior to, during and after therapy), heart failure, hypersensitivity reactions, lupus-like syndrome, malignancy. Perform screening for latent TB (prior to and during therapy), hepatitis B virus (HBV); HBV carriers.
Drug Interactions
Decreased WBC w/ sulfasalazine. Increased risk of serious infections and neutropenia w/ anakinra. Increased incidence of serious adverse events w/ abatacept. Higher incidence of non-cutaneous solid malignancies w/ cyclophosphamide. May diminish the therapeutic effect of live vaccines.
Lab Interference
May interfere w/ troponin determinations; other assays using murine monoclonal antibodies (e.g. creatine kinase-MB fraction, folate, β-HCG, thyrotropin, thyroxine, vancomycin).
Action
Description: Etanercept binds to tumour necrosis factor (TNF) and blocks its interaction w/ cell surface tumour necrosis factor receptors, thus preventing TNF-mediated cellular responses by rendering TNF biologically inactive.
Onset: Approx 2-3 wk; rheumatoid arthritis: 1-2 wk.
Pharmacokinetics:
Absorption: Slowly absorbed from the site of inj. Bioavailability: 76%. Time to peak plasma concentration: 48 hr.
Distribution: Crosses the placenta and enters breast milk. Volume of distribution (steady-state): 10.4 L.
Excretion: Half-life: Approx 70 hr.
Storage
Store between 2-8°C. Protect from light. Do not freeze.
ATC Classification
L04AB01 - etanercept ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
Disclaimer: This information is independently developed by MIMS based on Etanercept from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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