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JAK Inhibitor (JAK1/JAK3 Inhibitor) Pregnancy: D

Tofacitinib

Brand names: Xeljanz

Adult dose

Dose: 5 mg twice daily; extended-release: 11 mg once daily; UC: 10 mg BD (induction 8 weeks) then 5 mg BD
Route: oral
Frequency: twice daily (IR) or once daily (XR)
Max: 10 mg twice daily (UC induction)
First JAK inhibitor approved; ORAL Surveillance: increased MACE/malignancy at 10 mg BD vs 5 mg BD — use lowest effective dose

Paediatric dose

Route: oral
Frequency: twice daily
Max: 5 mg twice daily
Concentration: 1 mg/mL solution mg/ml
JIA ≥2 years: weight-based: <20 kg: 3.2 mg BD; 20–40 kg: 4 mg BD; >40 kg: 5 mg BD; solution available

Dose adjustments

Renal

Reduce to 5 mg once daily if eGFR <40 ml/min

Hepatic

Reduce dose in moderate hepatic impairment; avoid in severe

Clinical pearls

  • ORAL Surveillance trial: increased MACE, malignancy, DVT/PE at 10 mg BD — restricted use in high-risk patients
  • EMA/MHRA: restrict to patients over 65 years, smokers, or high CV/malignancy risk only if no alternatives
  • Highest herpes zoster rate among JAKi — shingles vaccination recommended before initiation

Contraindications

  • Active severe infections
  • Active TB
  • Pregnancy
  • ANC <500/mm³

Side effects

  • Herpes zoster (shingles — most common infectious AE)
  • URTI
  • Headache
  • Diarrhoea
  • DVT/PE
  • MACE
  • Malignancy

Interactions

  • Potent CYP3A4 inhibitors (reduce dose)
  • Potent CYP3A4 inducers (rifampicin — avoid)
  • Live vaccines (CI)
  • Immunosuppressants

Monitoring

  • FBC (monthly initially)
  • LFTs
  • Lipids
  • Signs of infection
  • DVT symptoms

Reference: BNFc; BNF 86; NICE TA480; ORAL Surveillance trial. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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