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TNF-α Inhibitor (Fusion Protein) Pregnancy: B

Etanercept

Brand names: Enbrel, Benepali, Erelzi

Adult dose

Dose: 25 mg SC twice weekly or 50 mg SC once weekly
Route: subcutaneous injection
Frequency: twice weekly or once weekly
Max: 50 mg/week
Pre-filled pen/syringe; alternate injection sites; screen for TB and hepatitis B/C before starting; live vaccines contraindicated

Paediatric dose

Dose: 0.4 mg/kg
Route: subcutaneous
Frequency: once weekly
Max: 25 mg per dose
Concentration: 10 mg/mL or 25 mg/0.5 mL or 50 mg/mL prefilled syringe mg/ml
JIA ≥2 years: 0.4 mg/kg once weekly (max 25 mg); psoriasis ≥6 years: 0.8 mg/kg once weekly (max 50 mg)

Dose adjustments

Renal

No dose adjustment required

Hepatic

No dose adjustment required

Paediatric weight-based calculator

JIA ≥2 years: 0.4 mg/kg once weekly (max 25 mg); psoriasis ≥6 years: 0.8 mg/kg once weekly (max 50 mg)

Clinical pearls

  • Only TNF inhibitor that is a fusion protein (not monoclonal antibody) — binds both TNF-α and TNF-β
  • TEMPO trial: etanercept + MTX superior to either alone in RA
  • Less effective for inflammatory bowel disease than monoclonal anti-TNF agents (infliximab, adalimumab) — caution in IBD comorbidity

Contraindications

  • Active infections (including sepsis)
  • Active TB (screen with IGRA/TST before starting)
  • Severe heart failure (NYHA III-IV)
  • Live vaccines

Side effects

  • Injection site reactions
  • Infections (bacterial, TB, fungal)
  • Demyelination (rare)
  • Lupus-like syndrome
  • Worsening CHF
  • Lymphoma (rare)

Interactions

  • Anakinra (avoid combination — serious infections)
  • Abatacept (avoid combination)
  • Live vaccines (CI during therapy)
  • Sulfasalazine (leucopenia — caution)

Monitoring

  • FBC, LFTs, CRP at 3-monthly intervals
  • TB screening before initiation
  • Signs of infection
  • Annual IGRA during therapy

Reference: BNFc; BNF 86; NICE TA130; TEMPO trial. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.