Formulary
Upadacitinib: Indications, Dosing, Side Effects and Interactions
Upadacitinib is a selective and reversible inhibitor of the Janus-associated tyrosine kinase JAK1.
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Upadacitinib: Indications, Dosing, Side Effects and Interactions
Upadacitinib is a selective and reversible inhibitor of the Janus-associated tyrosine kinase JAK1.
Drug action
Upadacitinib is a selective and reversible inhibitor of the Janus-associated tyrosine kinase JAK1.
Indications and dose
**Rheumatoid arthritis (under expert supervision),Psoriatic arthritis (under expert supervision)**
- **Adult** (By Mouth): 15 mg once daily, consider discontinuation of treatment if no response after 12 weeks, for treatment interruption due to side-effects-consult product literature.
**Ankylosing spondylitis (under expert supervision),Non-radiographic axial spondyloarthritis (under expert supervision)**
- **Adult** (By Mouth): 15 mg once daily, consider discontinuation of treatment if no response after 16 weeks, for treatment interruption due to side-effects-consult product literature.
**Atopic eczema (under expert supervision)**
- **Adult** (By Mouth): 15 mg once daily, a higher dose of 30 mg once daily may be appropriate for certain patients-consult product literature, consider discontinuation of treatment if no response after 12 weeks, for treatment interruption due to side-effects-consult product literature.
- **Elderly** (By Mouth): 15 mg once daily, consider discontinuation of treatment if no response after 12 weeks, for treatment interruption due to side-effects-consult product literature.
**Ulcerative colitis (under expert supervision)**
- **Adult** (By Mouth): Initially 45 mg once daily for 8 weeks, if an adequate therapeutic response is not achieved after 8 weeks, the initial dose can be extended for an additional 8 weeks, discontinue treatment if no response after 16 weeks, for treatment interruption due to side-effects-consult product literature, then maintenance 15 mg once daily, a higher maintenance dose of 30 mg once daily may be appropriate for certain patients-consult product literature, for treatment interruption due to side-effects-consult product literature.
- **Elderly** (By Mouth): Initially 45 mg once daily for 8 weeks, if an adequate therapeutic response is not achieved after 8 weeks, the initial dose can be extended for an additional 8 weeks, discontinue treatment if no response after 16 weeks, for treatment interruption due to side-effects-consult product literature, then maintenance 15 mg once daily, for treatment interruption due to side-effects-consult product literature.
**Crohn's disease (under expert supervision)**
- **Adult** (By Mouth): Initially 45 mg once daily for 12 weeks, if an adequate therapeutic response is not achieved after 12 weeks, the dose may be decreased to 30 mg once daily and given for an additional 12 weeks, discontinue treatment if no response after 24 weeks, for treatment interruption due to side-effects-consult product literature, then maintenance 15 mg once daily, a higher maintenance dose of 30 mg once daily may be appropriate for certain patients-consult product literature, for treatment interruption due to side-effects-consult product literature.
- **Elderly** (By Mouth): Initially 45 mg once daily for 12 weeks, if an adequate therapeutic response is not achieved after 12 weeks, the dose may be decreased to 30 mg once daily and given for an additional 12 weeks, discontinue treatment if no response after 24 weeks, for treatment interruption due to side-effects-consult product literature, then maintenance 15 mg once daily, for treatment interruption due to side-effects-consult product literature.
**Atopic eczema (under expert supervision) for upadacitinib**
- **Child 12-17 years (body-weight 30 kg and above)** (By mouth): 15 mg once daily, consider discontinuation of treatment if no response after 12 weeks, for treatment interruption due to side-effects-consult product literature.
Cautions
Chronic or recurrent infection; elderly (65 years and older); history of atherosclerotic cardiovascular disease or other cardiovascular risk factors; history of serious or opportunistic infection; patients at risk of gastro-intestinal perforation (new onset abdominal signs and symptoms should be evaluated promptly); predisposition to infection; risk factors for deep-vein thrombosis or pulmonary embolism; risk factors for malignancy; risk of viral reactivation (consult product literature); tuberculosis exposure Cautions, further information Immunisation Patients should receive all recommended vaccinations, including prophylactic varicella-zoster vaccination, before starting treatment; live vaccines are not recommended. M Tuberculosis Consider anti-tuberculosis therapy prior to initiation of upadacitinib in patients with previously untreated latent tuberculosis or in patients at risk of tuberculosis infection. Use upadacitinib with caution in patients who have travelled or resided in areas of endemic tuberculosis or endemic mycoses. M
Contraindications
Absolute lymphocyte count less than 0.5 x 10 9 cells/litre; absolute neutrophil count less than 1 x 10 9 cells/litre; active serious infection including localised infection; active tuberculosis; haemoglobin less than 8 g/dL
Side effects
Common or very common Abdominal pain; anaemia; cough; dyslipidaemia; fatigue; fever; headache; increased risk of infection; lymphopenia; nausea; neoplasms; neutropenia; skin reactions; weight increased Uncommon Sepsis Frequency not known Cardiovascular event; embolism and thrombosis; gastrointestinal perforation; malignancy; meningitis bacterial; reactivation of infections
Pregnancy
Manufacturer advises avoid-toxicity in animal studies.
Breast feeding
Manufacturer advises avoid-present in milk in animal studies.
Hepatic impairment
Avoid in severe impairment (no information available). M
Renal impairment
Caution in severe impairment (limited information available). M Dose adjustments When used for Atopic eczema: A dose of 15 mg once daily should not be exceeded in severe impairment. M When used for Ulcerative colitis or Crohn's disease: An initial dose of 30 mg once daily and a maintenance dose of 15 mg once daily should not be exceeded in severe impairment. M
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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