Generic Name

Etanercept

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Classification

FDA Approved Indications

• Moderate to severe rheumatoid arthritis
• Juvenile idiopathic arthritis
• Psoriasis (plaque psoriasis)
• Ankylosing spondylitis
• Psoriatic arthritis
• Plaque psoriasis

Mechanism of Action

Etanercept is a fusion protein that acts as a decoy receptor for TNF-α, binding to it and preventing it from activating TNF receptors on cell surfaces, thereby reducing inflammation and immune response.

Dosage and Administration

Adult: Typically 50 mg once weekly by subcutaneous injection. Dose adjustments may be necessary based on the condition.

Pediatric: Dose varies based on weight and indication; for juvenile idiopathic arthritis, usually 0.8 mg/kg once weekly, up to a maximum of 50 mg.

Geriatric: No specific dosing adjustments, but monitor for increased risk of infections.

Renal Impairment: No specific adjustment required; caution advised.

Hepatic Impairment: No specific adjustment required.

Pharmacokinetics

Absorption: Subcutaneous administration with maximum serum concentrations reached in 48-125 hours.

Distribution: Once absorbed, distributes mainly to the extracellular fluid.

Metabolism: Metabolized via proteolytic pathways, similar to other proteins.

Excretion: Eliminated via proteolytic degradation, not primarily cleared by the kidneys.

Half Life: Approximately 4.4 days.

Contraindications

• Active infections, including tuberculosis
• Hypersensitivity to etanercept or its components

Precautions

• History of recurrent infections
• Patient with demyelinating diseases
• Congestive heart failure
• Screen for latent tuberculosis prior to therapy
• Use caution in patients with hepatitis B or C

Adverse Reactions - Common

• Injection site reactions (Common)
• Infections (Common)
• Headache (Common)

Adverse Reactions - Serious

• Serious infections (including tuberculosis) (Uncommon)
• Reactivation of hepatitis B (Rare)
• Potential increased risk of lymphoma and other malignancies (Rare)

Drug-Drug Interactions

• Other biologic agents or immunosuppressants may increase risk of infections

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Report signs of infection promptly.
• Use proper injection technique and rotate injection sites.
• Avoid live vaccines during therapy.
• Inform healthcare provider of all medications.

Special Considerations

Black Box Warnings:

• Serious infections, including tuberculosis and bacterial sepsis

Genetic Factors: None established

Lab Test Interference: Potential false-positive tests for tuberculosis or infectious diseases.

Overdose Management

Signs/Symptoms: Potential for increased immunosuppression leading to infections.

Treatment: Supportive care; discontinuation of drug if overdose suspected.

Storage and Handling

Storage: Refrigerate at 2°C to 8°C (36°F to 46°F). Do not freeze.

Stability: Stable until expiration date when stored as recommended.