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JAK Inhibitor (IBD) Pregnancy: Contraindicated — teratogenic in animal studies. Effective contraception required during treatment and for 4 weeks after stopping. MHRA 2022.

Upadacitinib

Brand names: Rinvoq

Adult dose

Dose: 45 mg induction (8 weeks UC; 12 weeks CD), then 15–30 mg maintenance
Route: Oral
Frequency: Once daily
Max: 45 mg/day induction, 30 mg/day maintenance
Induction: 45 mg once daily for 8 weeks (UC) or 12 weeks (CD). Maintenance: 15 mg once daily (UC); 15–30 mg once daily (CD). 30 mg dose reserved for patients who would otherwise lose response. Source: BNF 90; MHRA 2022 JAK class restrictions.

Paediatric dose

Dose: Not licensed under 18 years for IBD N/A/kg
Route: Oral
Frequency: N/A
Max: N/A
Upadacitinib is not licensed for paediatric IBD. Licensed in paediatric JIA from 2 years for other indications — IBD indication adults only.

Dose adjustments

Renal

eGFR 15–29 mL/min: use with caution, dose reduction may be needed. eGFR <15 mL/min: not recommended. No dose adjustment for eGFR ≥30 mL/min.

Hepatic

Mild (Child-Pugh A): no adjustment. Moderate (Child-Pugh B): not recommended. Severe (Child-Pugh C): contraindicated.

Paediatric weight-based calculator

Upadacitinib is not licensed for paediatric IBD. Licensed in paediatric JIA from 2 years for other indications — IBD indication adults only.

Clinical pearls

  • MHRA 2022 JAK class restrictions: ONLY use in patients aged ≥65 years, or with cardiovascular risk factors, or history of malignancy, or smokers if no adequate alternative exists — applies to all JAK inhibitors (tofacitinib, baricitinib, upadacitinib, filgotinib).
  • U-ACHIEVE (NEJM 2022) UC trial: 45 mg induction achieved clinical remission 26% vs 5% placebo at week 8. U-EXCEED (NEJM 2023) CD trial: 39% vs 21% remission at week 12.
  • Acne-like rash is JAK class effect — appears on trunk and face within weeks of starting. Reassure patients — usually manageable with topical agents. Not true acne — different pathophysiology.
  • IGRA (QuantiFERON) mandatory before starting: latent TB must be treated before initiating. Chest X-ray and hepatitis B serology also required pre-treatment.
  • Herpes zoster: consider live attenuated varicella-zoster vaccine (Zostavax) at least 4 weeks before starting in non-immune patients ≥50 years — recombinant Shingrix preferred (can give during treatment as non-live). Source: BNF 90; MHRA Drug Safety Update 2022.

Contraindications

  • Active serious infection (including TB — screen with IGRA before starting)
  • Severe hepatic impairment (Child-Pugh C)
  • Pregnancy (teratogenic — effective contraception required, MHRA 2022)
  • Concurrent use with other JAK inhibitors or biologics
  • Age <18 years for IBD indication

Side effects

  • Upper respiratory tract infections (most common — ~15% induction phase)
  • Acne-like rash (JAK class effect — distinct from acne vulgaris, often on trunk)
  • Nasopharyngitis, headache, nausea
  • Herpes zoster reactivation (MHRA class warning — VZV vaccination recommended before starting)
  • Thrombocytopenia, neutropenia (monitor FBC)
  • Elevated liver enzymes, CPK elevation
  • MHRA 2022 class warning: increased risk of major adverse cardiovascular events (MACE), VTE, malignancy, and all-cause mortality — particularly age ≥65 years, smokers, patients with CV risk factors or malignancy history

Interactions

  • Strong CYP3A4 inhibitors (e.g. clarithromycin, itraconazole): increase upadacitinib exposure — avoid or reduce dose
  • Strong CYP3A4 inducers (e.g. rifampicin): reduce upadacitinib levels — avoid
  • Live vaccines: contraindicated during treatment — update all vaccinations before starting
  • Other JAK inhibitors or biologics: do not combine
  • Immunosuppressants (azathioprine, ciclosporin): increased infection risk

Monitoring

  • FBC at baseline, 4–8 weeks, then every 3 months (neutrophils, lymphocytes, haemoglobin, platelets)
  • Liver function tests at baseline and periodically
  • Lipid profile (LDL cholesterol increases — monitor at 12 weeks and periodically)
  • CPK if muscle symptoms
  • Skin examination (malignancy screening)
  • Blood pressure monitoring

Reference: BNFc; BNF 90; MHRA Drug Safety Update 2022 (JAK inhibitors); Danese et al. NEJM 2022 (U-ACHIEVE); Loftus et al. NEJM 2023 (U-EXCEED); NICE TA 763 (upadacitinib for UC). Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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