Discontinue use & institute appropriate therapy if clinically significant hypersensitivity reaction (eg, anaphylaxis & angioedema) occurs. Not recommended to be used in combination w/ other potent immunosuppressants (eg, azathioprine, ciclosporin, tacrolimus & biologic DMARDs or other Janus kinase inhibitors) due to risk of additive immunosuppression. Potential serious & fatal infections. Not to be initiated in patients w/ active, serious infection, including localised infections. Consider the risks & benefits prior to initiating treatment in patients w/ chronic or recurrent infection, who have been exposed to TB, w/ serious or opportunistic infection history, who have resided or travelled in areas of endemic TB or mycoses or w/ underlying conditions that may predispose them to infection. Higher rate of serious infections was observed w/ upadacitinib 30 mg compared to 15 mg. Closely monitor for the development of signs & symptoms of infection during & after treatment. Interrupt therapy if patient develops serious or opportunistic infection. Screen patient for TB before starting therapy. Consider anti-TB therapy prior to initiation in patients w/ previously untreated latent TB or in patients w/ TB infection risk factors. Monitor for the development of signs & symptoms of TB including patients who tested -ve for latent TB infection prior to therapy. Potential herpes virus reactivation. Interrupt therapy if patient develops herpes zoster. Perform screening for viral hepatitis & monitor for reactivation before starting & during therapy. Not recommended to use live, attenuated vaccines during or immediately prior to therapy. Recommended that patients be brought up to date w/ all immunisations including prophylactic zoster vaccinations prior to & during treatment. Consider the benefits & risks prior to initiating or continuing therapy particularly in patients w/ known malignancy (other than successfully treated NMSC), those who develop malignancy when on treatment & those who are current or past smokers. Possible NMSC; periodic skin exam is recommended for patients at increased risk for skin cancer. Consider benefits & risks for individual patient prior to initiating or continuing therapy particularly in those who are current or past smokers & w/ other CV risk factors. Inform patients about symptoms of serious CV events & steps to take if they occur. Not to be initiated or should be temporarily interrupted in patients w/ ANC <1 x 109
cells/L, ALC <0.5 x 109
cells/L or Hb <8 g/dL. Increased lipid parameters including total cholesterol, LDL-C & HDL-C. Increased incidence of liver enzyme elevation. Interrupt therapy if ALT or AST increased & drug-induced liver injury is suspected. Patients at high risk of DVT/pulmonary embolism (PE). Discontinue use & promptly evaluate, followed by appropriate treatment if symptoms of thrombosis occur. Patients who may be at risk for GI perforation (eg, patients w/ diverticular disease, history of diverticulitis or who are taking NSAIDs, corticosteroids or opioids). Patients w/ new onset abdominal signs & symptoms should be evaluated promptly for early identification of GI perforation. 15 mg once daily should be used w/ caution in patients receiving chronic treatment w/ strong CYP3A4 inhibitors. 30 mg once daily dose is not recommended for patients w/ atopic dermatitis receiving chronic treatment w/ strong CYP3A4 inhibitors. Avoid food or drinks containing grapefruit during treatment. Monitor for changes in disease activity during co-administration w/ strong CYP3A4 inducers. Severe renal impairment [RA, psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis, atopic dermatitis & ulcerative colitis (maintenance): may administer 15 mg once daily w/ caution; ulcerative colitis (induction): may administer 30 mg once daily w/ caution]. Advise women of childbearing potential to use effective contraception during treatment & for 4 wk following the final upadacitinib dose. Female paed patients who experience menarche during treatment should inform the treating physician. Not to be used during breast-feeding. No safety & efficacy data in childn <12 yr w/ atopic dermatitis; <18 yr w/ RA, psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis & ulcerative colitis. Elderly ≥75 yr; >15 mg once daily is not recommended in elderly ≥65 yr w/ atopic dermatitis & for ulcerative colitis maintenance therapy.