Upadacitinib
Dosing in kidney impairment
Renal Impairment For patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, pJIA, or giant cell arteritis no dosage adjustment is needed in patients with mild (eGFR 60 to < 90 mL/min/1.73 m 2 ), moderate (eGFR 30 to < 60 mL/min/1.73 m 2 ), or severe renal impairment (eGFR 15 to < 30 mL/min/1.73 m 2 ).
For patients with atopic dermatitis, the maximum recommended dosage of RINVOQ is 15 mg once daily for patients with severe renal impairment. No dosage adjustment is needed in patients with mild or moderate renal impairment. For patients with ulcerative colitis or Crohn’s disease, the recommended dosage of RINVOQ for severe renal impairment is 30 mg once daily for induction and 15 mg once daily for maintenance.
No dosage adjustment is needed in patients with mild or moderate renal impairment [see Dosage and Administration] . RINVOQ/RINVOQ LQ has not been studied in patients with end stage renal disease (eGFR <15 mL/min/1.73m 2 ). Use in patients with atopic dermatitis, ulcerative colitis, or Crohn’s disease with end stage renal disease is not recommended [see Clinical Pharmacology] .
Dosing in liver impairment
Hepatic Impairment The use of RINVOQ/RINVOQ LQ has not been studied in patients with severe hepatic impairment (Child Pugh C), and is therefore not recommended [see Dosage and Administration and Clinical Pharmacology] . For patients with rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, pJIA, or giant cell arteritis, no dosage adjustment is needed in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment.
For patients with ulcerative colitis or Crohn’s disease, the recommended dosage of RINVOQ for mild to moderate hepatic impairment is 30 mg once daily for induction and 15 mg once daily for maintenance [see Dosage and Administration].
| Laboratory Measure | Action |
| Absolute Neutrophil Count (ANC) | Interrupt treatment if ANC is less than 1000 cells/mm3; treatment may be restarted once ANC returns above this value |
| Absolute Lymphocyte Count (ALC) | Interrupt treatment if ALC is less than 500 cells/mm3; treatment may be restarted once ALC returns above this value |
| Hemoglobin (Hb) | Interrupt treatment if Hb is less than 8 g/dL; treatment may be restarted once Hb returns above this value |
| Hepatic transaminases | Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. |
Preparation and administration
Important Administration Instructions RINVOQ LQ oral solution is not substitutable with RINVOQ extended-release tablets [see Dosage and Administration ( 2.4 , 2.10 )]. Changes between RINVOQ LQ oral solution and RINVOQ extended-release tablets should be made by the health care provider. RINVOQ/RINVOQ LQ should be taken orally with or without food [see Clinical Pharmacology].
RINVOQ tablets should be swallowed whole. RINVOQ tablets should not be split, crushed, or chewed. RINVOQ LQ should be administered using the provided press-in bottle adapter and oral dosing syringe [see Instructions for Use ] . RINVOQ LQ is dosed twice daily [see Dosage and Administration ( 2.4 , 2.10 )].