upadacitinib hemihydrate at a glance
Medicine class
Selective, reversible Janus kinase inhibitor.
Form
Prolonged-release tablet that must be swallowed whole.
Food
May be taken with or without food, but grapefruit should be avoided.
Important safety issue
Can increase susceptibility to serious infection and requires assessment of cardiovascular, cancer and blood-clot risks.
What is upadacitinib hemihydrate used for?
UK-licensed uses represented by the selected product include:
Moderate to severe rheumatoid arthritis in adults after inadequate response or intolerance to disease-modifying treatment.
Active psoriatic arthritis in adults after inadequate response or intolerance to disease-modifying treatment.
Active non-radiographic axial spondyloarthritis with objective inflammation, and active ankylosing spondylitis, in eligible adults.
Giant cell arteritis in adults.
Moderate to severe atopic dermatitis in eligible adults and adolescents aged 12 years and over.
Moderately to severely active ulcerative colitis or Crohn’s disease in adults after inadequate response, loss of response or intolerance to conventional or biological treatment.
How does upadacitinib hemihydrate work?
Upadacitinib reversibly inhibits Janus kinase signalling, preferentially pathways involving JAK1. This reduces signals from several cytokines that drive immune activation and inflammation in affected joints, skin, bowel and blood vessels.
upadacitinib hemihydrate preparations and strengths
Modified-release tablet
Route: Oral
Strengths: 15 mg, 30 mg, 45 mg
How to take upadacitinib hemihydrate
Follow the specialist’s prescription. The prolonged-release tablet should be swallowed whole with water and must not be split, crushed, chewed or broken. It may be taken with or without food; avoid grapefruit and grapefruit-containing food or drink.
Do not change or stop treatment without discussing it with the prescribing team.
Contact the clinical team if tablet residue repeatedly appears in stool or stoma output, particularly if symptoms are not controlled.
upadacitinib hemihydrate side effects
Common or expected effects
- Upper respiratory infections, bronchitis, cough or influenza
- Acne, rash, folliculitis or cold sores
- Headache, dizziness or vertigo
- Nausea or abdominal pain
- Fatigue or fever
- Shingles or urinary infection
- Changes in blood counts, cholesterol, liver enzymes or creatine kinase
Get urgent medical advice
- Serious or opportunistic infection, including pneumonia, sepsis or tuberculosis
- Anaphylaxis or angioedema
- Deep-vein thrombosis or pulmonary embolism
- Heart attack or stroke symptoms
- Sudden visual disturbance suggesting retinal vein occlusion
- Severe abdominal pain suggesting diverticulitis or bowel perforation
- New skin growths or changing moles requiring assessment
upadacitinib hemihydrate in pregnancy
Upadacitinib is contraindicated during pregnancy because human evidence is limited and animal studies found developmental harm. Effective contraception is required during treatment and for four weeks after stopping. Anyone planning pregnancy or becoming pregnant while taking it should contact the specialist promptly rather than making treatment changes alone.
upadacitinib hemihydrate while breastfeeding
Upadacitinib should not be used while breastfeeding because transfer into human milk is unknown and risk to the infant cannot be excluded. The specialist should discuss whether breastfeeding or treatment should be discontinued.
upadacitinib hemihydrate interactions
The prescriber and pharmacist should review all medicines, supplements and vaccines before treatment.
Strong CYP3A4 inhibitors, including clarithromycin and azole antifungals
Can increase upadacitinib exposure and adverse-effect risk; an alternative or treatment adjustment may be needed.
Strong CYP3A4 inducers, including rifampicin and phenytoin
Can reduce upadacitinib exposure and may reduce its effect.
Grapefruit products
Can increase upadacitinib exposure and should be avoided.
Common questions about upadacitinib hemihydrate
Answers are fully visible for fast scanning and source review.
What is upadacitinib hemihydrate used for?
It is a specialist treatment for selected inflammatory joint, skin, bowel and blood-vessel conditions, including rheumatoid arthritis, atopic dermatitis, inflammatory bowel disease and giant cell arteritis.
Is upadacitinib hemihydrate a biologic?
No. It is an orally administered targeted synthetic immunosuppressant called a JAK inhibitor.
Can upadacitinib hemihydrate tablets be crushed?
No. They are prolonged-release tablets and must be swallowed whole without splitting, crushing, chewing or breaking.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.