etanercept: clinical use

Prescribing considerations

• Initiation and supervision should be by an experienced specialist; provide and review the Patient Card.
• Assess infection risk, including opportunistic infection exposure.
• Evaluate for active and latent tuberculosis and test for hepatitis B before treatment.
• Review vaccination status before initiation where possible; avoid concurrent live vaccines.
• Use caution with previous demyelinating disease, blood dyscrasias, congestive heart failure, hepatitis C or significant infection predisposition.
• Record product name and batch number for traceability.

Contraindications and cautions

• Hypersensitivity to etanercept or a formulation excipient
• Sepsis or risk of sepsis
• Active infection, including chronic or localised infection

Monitoring

• Assess for infection before, during and after treatment; stop treatment if a serious infection develops.
• Monitor patients with previous hepatitis B for reactivation during and after treatment.
• Urgently investigate persistent fever, sore throat, bruising, bleeding or pallor, including a full blood count.
• Consider periodic skin examination when skin-cancer risk factors are present.
• Promptly review new neurological, autoimmune, hepatic or heart-failure symptoms.
• Assess clinical response through the specialist service.

Clinical pharmacology

Etanercept is a recombinant human p75 TNF-receptor–Fc fusion protein that competitively binds TNF and lymphotoxin, preventing TNF-receptor activation. Subcutaneous absorption and elimination are slow, with an approximate mean half-life of 70 hours.

Formulation and product differences

• Selected products include ready-to-use pre-filled syringes and a paediatric powder-and-solvent presentation requiring reconstitution.
• Fixed-content pre-filled devices may be unsuitable when an individually measured paediatric amount is required.
• The Enbrel paediatric diluent syringe cap contains dry natural rubber latex.
• Storage, preparation, appearance checks and device technique are product-specific.

Injection

Route: Parenteral

Strengths: 10 mg, 25 mg, 50 mg