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Etanercept

Generic Medicine
Indications

Rheumatoid Arthritis (Adults): Etanercept is used to reduce symptoms, achieve significant clinical improvement, slow joint damage, and improve physical function in adults with moderate to severe rheumatoid arthritis. It may be used alone or in combination with methotrexate (MTX), especially when other disease-modifying antirheumatic drugs (DMARDs), including MTX (unless unsuitable), have not worked well.

Juvenile Idiopathic Arthritis (Children): Etanercept is indicated for children aged 2 years and older with polyarticular juvenile idiopathic arthritis who have not responded adequately to one or more DMARDs.

Psoriatic Arthritis (Adults): Etanercept helps reduce symptoms, prevent joint damage progression, and improve physical function in patients with psoriatic arthritis. It can be used alone or with methotrexate if MTX alone is not effective.

Ankylosing Spondylitis (Adults): Etanercept is used to reduce symptoms in patients with active ankylosing spondylitis.

Plaque Psoriasis (Adults): Etanercept is indicated for adults (18 years and older) with moderate to severe chronic plaque psoriasis who are suitable for systemic therapy or phototherapy.

Plaque Psoriasis (Children): Etanercept is used for children aged 6 years and above with severe chronic plaque psoriasis who do not respond to or cannot tolerate other systemic treatments or phototherapy.

Pharmacology

Etanercept is a tumor necrosis factor (TNF) inhibitor. It is a genetically engineered protein made using recombinant DNA technology in Chinese hamster ovary (CHO) cells. It consists of a fusion of: The TNF receptor (p75) part that binds TNF. The Fc portion of human IgG1. Etanercept works by binding specifically to TNF and blocking its interaction with cell surface receptors. TNF is a cytokine involved in inflammation and immune responses. High levels of TNF are found in diseases like rheumatoid arthritis and juvenile arthritis, where it plays a major role in inflammation and joint damage. By inhibiting TNF, etanercept helps reduce inflammation and prevent disease progression.

Dosage Administration

Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis: Patients aged 18 years or older- 50 mg Etanercept per week administered either once weekly (as one subcutaneous injection using a 50 mg syringe or as two 25 mg injections given at the same time) or 25 mg Etanercept twice weekly (72 to 96 hours apart) as a subcutaneous injection. Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with Etanercept in adults. 25 mg once weekly gives a slower response and may be less effective.

Plaque psoriasis: The dose of etanercept is 50 mg syringe once weekly (as one subcutaneous injection using a 50 mg syringe or as two 25 mg injections given at approximately the same time) or 25 mg twice weekly (72 to 96 hours apart) as a subcutaneous injection. Higher responses may be achieved from initial treatment with a dose of 50 mg twice weekly for up to 12 weeks, followed, if necessary, by a dose of 50 mg once weekly or 25 mg twice weekly.

Adult patients may be treated intermittent or continuously based on physician judgment and individual patient needs. Treatment should be discontinued in patients who show no response after 12 weeks. With intermittent use, treatment cycles subsequent to the initial cycle should use a dose of 50 mg once weekly. No dose adjustment is required for elderly and or patient with renal and hepatic impairment. Patient weighs less than 62.5 kg should be accurately dosed on an mg/kg basis. Patients weighing 62.5 kg or more may be fixed-dose prefilled syringe.

Juvenile idiopathic arthritis: Children (⩾2 to <18 years): 0.4 mg/kg (up to 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 <2 years of age.

Pediatric plaque psoriasis: Children (⩾6 to <18 years): 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly for up to 24 weeks. Treatment should be discontinued in patients who show no response after 12 weeks. If retreatment of etanercept is indicated, the above guidance on treatment duration should be followed. The dose should be 0.8 mg/kg (up to maximum of 50 mg per dose) once weekly.

Administer etanercept as subcutaneous injections in the thigh, abdomen or upper arm. Given each new injection at least 3 cm from a previous site. Do not use in the area where the skin is tender, bruised, red or hard. The injection should be performed under supervision of qualified healthcare professional. Before injection, single-use prefilled syringe should be allowed to reach room temperature (approximately 15-30 minutes). The needle cover should not be removed while allowing the pre-filled syringe to reach at room temperature. Before disposal of blank PFS, please activate the needle guard to avoid any chance of needle-stick injury.

Contraindications

Etanercept should not be used in patients who are hypersensitive to etanercept or any of its components. It is contraindicated in patients with sepsis or at risk of sepsis. Treatment should also not be started in patients with serious active infections, including chronic or localized infections.

Side Effects

Very common: Infections (such as common cold, sinusitis, bronchitis, urinary tract infections, and skin infections); injection site reactions including bleeding, bruising, redness, itching, pain, and swelling. These reactions are usually less frequent after the first month of treatment, although they may occur again at previously used injection sites.

Common: Allergic reactions, fever, itching, and formation of autoantibodies (antibodies against normal body tissues).

Uncommon: Serious infections (e.g., pneumonia, deep skin infections, joint infections, blood infections); low platelet count; non-melanoma skin cancer; angioedema (localized swelling); hives; eye inflammation; new or worsening psoriasis; rash; lung inflammation or scarring; inflammation of blood vessels affecting multiple organs.

Pregnancy & Lactation

The safety of etanercept during pregnancy has not been established. It should only be used if clearly necessary. Its safety during breastfeeding is also unknown. Etanercept may pass into breast milk, as seen in animal studies. Therefore, a decision should be made whether to stop breastfeeding or discontinue the drug.

Precautions & Warnings

Special care is required in patients with:

  • Allergic reactions
  • Infections or recent surgery
  • Diabetes with infections
  • Tuberculosis
  • Hepatitis B or C
  • Blood disorders
  • Nervous system or eye disorders
  • Congestive heart failure
  • Cancer
  • Chickenpox
  • Latex sensitivity
  • Alcohol abuse
  • Wegener’s granulomatosis
  • Use of anti-diabetic medications
Overdose Effects

The maximum safe dose in humans is not established. High doses have been used in studies without serious toxicity. There is no specific antidote for etanercept.

Therapeutic Class

Immunosuppressant

Storage Conditions

Store etanercept in a refrigerator at 2–8°C. Do not freeze or shake. Protect from light and keep out of reach of children.

Common Questions

What does Etanercept do?

What are the side effects of Etanercept?

What happens if you take too much Etanercept?

Can Etanercept be taken during pregnancy?

Is Etanercept safe for pregnant women?

No available drugs found

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