Upadacitinib

Maintenance dose choice is based on individual patient presentation: 15 mg once daily is recommended for patients at higher risk of venous thromboembolism, major adverse cardiovascular events and malignancy, and for patients 65 years of age and older; 30 mg once daily may be appropriate for patients with high disease burden, for ulcerative colitis patients requiring 16-week induction, or for those without adequate therapeutic benefit on 15 mg once daily — in each case only where the patient is not at higher risk of VTE, MACE and malignancy. The lowest effective dose to maintain response should be used. Ulcerative colitis: if adequate therapeutic benefit is not achieved by week 8, 45 mg once daily may be continued for a further 8 weeks; discontinue in any patient showing no evidence of therapeutic benefit by week 16. Crohn's disease: 30 mg once daily maintenance may be appropriate for patients who did not achieve adequate benefit after the initial 12-week induction — discontinue if there is no evidence of therapeutic benefit after 24 weeks. In patients who have responded, corticosteroids may be reduced and/or discontinued in accordance with standard of care. Interaction adjustment: for ulcerative colitis and Crohn's disease patients receiving strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin), the recommended induction dose is 30 mg once daily and the recommended maintenance dose is 15 mg once daily. Do not initiate treatment if ALC is below 0.5 x 10^9 cells/L, ANC is below 1 x 10^9 cells/L, or haemoglobin is below 8 g/dL; interrupt treatment if these thresholds are crossed on therapy and restart once values recover. Interrupt for serious infection until controlled, and temporarily interrupt if drug-induced liver injury is suspected. Other indications in the same SPC (not this page's focus): rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis 15 mg once daily; giant cell arteritis 15 mg once daily with a tapering course of corticosteroids; atopic dermatitis 15 mg or 30 mg once daily. Paediatric: safety and effectiveness in paediatric patients with ulcerative colitis or Crohn's disease have not been established (US label §8.4) — verify any paediatric use against a children's formulary.