Etanercept


Generic Medicine Info
Indications and Dosage
Subcutaneous
Psoriatic arthritis
Adult: For the treatment of active and progressive cases in patients who had an inadequate response to DMARDs: 25 mg twice weekly at intervals of 3-4 days or 50 mg once weekly. Discontinue treatment if no adequate response after 12 weeks.
Child: In patients who have had an inadequate response to or who have proved intolerant of conventional therapy: ≥12 years 0.4 mg/kg twice weekly at intervals of 3-4 days. Max: 25 mg/dose. Alternatively, 0.8 mg/kg once weekly. Max: 50 mg/dose. Discontinue treatment if no adequate response after 4 months. Dosing recommendations may vary among countries (refer to specific product guidelines).

Subcutaneous
Ankylosing spondylitis, Non-radiographic axial spondyloarthritis
Adult: For active cases in patients who had an inadequate response to conventional therapy: 25 mg twice weekly at intervals of 3-4 days or 50 mg once weekly. Discontinue treatment if no adequate response after 12 weeks.

Subcutaneous
Rheumatoid arthritis
Adult: For moderate to severe active cases in patients who had an inadequate response to disease-modifying antirheumatic drugs (DMARDs): As monotherapy or in combination with methotrexate: 25 mg twice weekly at intervals of 3-4 days. Alternatively, 50 mg once weekly. Discontinue treatment if no adequate response after 6 months.

Subcutaneous
Enthesitis-related arthritis
Adult: For moderate to severe cases in patients who are intolerant to, failed to respond to, or have contraindications to other systemic therapy or phototherapy: 25 mg twice weekly or 50 mg once weekly. Alternatively, 50 mg twice weekly at intervals of 3-4 days for up to 12 weeks, if necessary, followed by 25 mg twice weekly or 50 mg once weekly. Continue therapy until remission is achieved, for up to 24 weeks. Discontinue treatment if no adequate response after 12 weeks.
Child: For chronic severe cases in patients who are inadequately controlled or intolerant to other systemic therapy or phototherapies: ≥6 years 0.8 mg/kg once weekly for up to 24 weeks. Max: 50 mg/dose. Discontinue treatment if no adequate response after 12 weeks.

Subcutaneous
Plaque psoriasis
Child: In patients who have had an inadequate response to or who have proved intolerant of conventional therapy: ≥2 years 0.4 mg/kg twice weekly at intervals of 3-4 days. Max: 25 mg/dose. Alternatively, 0.8 mg/kg once weekly. Max: 50 mg/dose. Discontinue treatment if no adequate response after 4 months.

Subcutaneous
Polyarticular juvenile idiopathic arthritis
Child: In patients who have had an inadequate response to or who have proved intolerant of conventional therapy: ≥12 years 0.4 mg/kg twice weekly at intervals of 3-4 days. Max: 25 mg/dose. Alternatively, 0.8 mg/kg once weekly. Max: 50 mg/dose. Discontinue treatment if no adequate response after 4 months. Treatment recommendations may vary among countries (refer to specific product guidelines).
What are the brands available for Etanercept in Indonesia?
Other Known Brands
  • Enbrel
Reconstitution
Powder for inj: Reconstitute by slowly adding 1 mL of bacteriostatic water for inj, gently swirl to avoid foaming.
Contraindications
Sepsis or risk of sepsis, serious active infection including chronic or localised infections.
Special Precautions
Patient with pre-existing or recent onset of CNS demyelinating disorders, CHF or decreased left ventricular function, previous history of blood dyscrasias, history of seizures, HIV-positive patients, varicella virus exposure, previous HBV infection, history of hepatitis C, moderate to severe alcoholic hepatitis. Patients with rheumatic musculoskeletal disease undergoing hip or knee replacement surgery. Concurrent administration of live vaccines. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Anaphylactic or hypersensitivity reactions, antibody formation, immunosuppression, autoimmune disorder (e.g. lupus-like syndrome, autoimmune hepatitis), worsening and new-onset of heart failure, exacerbation or new-onset of seizures, hepatotoxicity, increased liver enzymes, melanoma, non-melanoma skin cancer, hypoglycaemia, inj site reactions. Rarely, exacerbation of CNS demyelinating disorders, peripheral demyelinating polyneuropathies (including Guillain-Barre syndrome), HBV reactivation, worsening of HCV.
Eye disorders: Uveitis, scleritis.
Gastrointestinal disorders: Diarrhoea, inflammatory bowel disease.
General disorders and administration site conditions: Fever.
Infections and infestations: URTI, respiratory tract infection.
Nervous system disorders: Headache.
Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria, angioedema, psoriasis, psoriasiform rash.
Potentially Fatal: Serious infections (e.g. bacterial sepsis, active TB, reactivation of latent TB, opportunistic infections including invasive fungal infections, listeriosis, legionellosis), lymphoma and other malignancies (e.g. Hodgkin's and non-Hodgkin's lymphomas), ILD. Rarely, haematologic reactions (e.g. pancytopenia, aplastic anaemia).
Patient Counseling Information
Women of childbearing potential must use proven birth control methods during treatment and 3 weeks after stopping the treatment.
Monitoring Parameters
Perform TB screening (active and latent TB), pregnancy test, C-reactive protein, and serologic testing (e.g. HBV, HCV antibody, HIV) prior to treatment initiation. Obtain CBC with differential before starting treatment; CBC, LFTs at 4 and 12 months or as clinically indicated. Evaluate for the presence of malignancy, lymphadenopathy, and infections before and during therapy. Assess for CHF, neurological symptoms, lupus-like syndrome, and hypersensitivity or inj site reactions during treatment. Evaluate hepatitis B carriers periodically for signs and symptoms of active hepatitis B infection after treatment.
Drug Interactions
Increased incidences of serious adverse effects with abatacept. Significant decrease in mean WBC cell counts with sulfasalazine. May decrease the therapeutic effect of live vaccines.
Potentially Fatal: Increased risk of serious infection and neutropenia with anakinra.
Action
Description:
Mechanism of Action: Etanercept is a recombinant DNA-derived protein of soluble human tumour necrosis factor (TNF) receptor attached to the Fc portion of human IgG1. It binds to TNF and prevents its interaction with endogenous cell surface receptors, thus preventing TNF-mediated cellular responses by rendering TNF biologically inactive.
Onset: Approx 2-3 weeks; 1-2 weeks (rheumatoid arthritis).
Pharmacokinetics:
Absorption: Slowly absorbed from the site of inj. Bioavailability: 60%. Time to peak plasma concentration: Rheumatoid arthritis: 69 ± 34 hours.
Distribution: Crosses the placenta and enters breast milk.
Excretion: Elimination half-life: Approx 70 hours.
Storage
Store between 2-8°C. Do not freeze and shake. Protect from light. Pre-filled syringe or pen, single-dose vial, or auto-injectors: May be stored up to Max of 25°C for a single period of up to 4 weeks; do not return to refrigerated storage once removed. Discard if not used within 4 weeks of removal from refrigeration. Storage recommendations may vary among countries and between individual products (refer to specific product guidelines).
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants
ATC Classification
L04AB01 - etanercept ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
References
Benepali 50 mg Solution for Injection in Pre-filled Pen (Samsung Bioepis UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 05/07/2024.

Brayfield A, Cadart C (eds). Etanercept. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/07/2024.

Enbrel 25 mg Solution for Injection in a Pre-filled Syringe (Pfizer [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 05/07/2024.

Enbrel 25 mg Solution for Injection in Pre-filled Pen (Pfizer Limited). MHRA. https://products.mhra.gov.uk. Accessed 05/07/2024.

Enbrel Solution (Immunex Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/07/2024.

Erelzi 25 mg Solution for Injection in Pre-filled Syringe (Sandoz GmbH). MHRA. https://products.mhra.gov.uk. Accessed 05/07/2024.

Etanercept. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 05/07/2024.

Eucept 50 mg/mL Solution for Injection in Pre-filled Syringe (Cipla Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 05/07/2024.

Joint Formulary Committee. Etanercept. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/07/2024.

Paediatric Formulary Committee. Etanercept. BNF for Children [online]. London. BMJ Group, Pharmaceutical Press, and RCPCH Publications. https://www.medicinescomplete.com. Accessed 08/07/2024.

Pfizer New Zealand Limited. Enbrel 25 mg Powder for Injection, 25 mg and 50 mg Solution for Injection in Pre-filled Syringe, and 25 mg and 50 mg Solution for Injection in Auto-injector data sheet 16 April 2024. Medsafe. http://www.medsafe.govt.nz. Accessed 05/07/2024.

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 © 2025 MIMS. All rights reserved. Powered by MIMS.com
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