Treatment with upadacitinib should be initiated and supervised by physicians experienced in the diagnosis and treatment of rheumatoid arthritis.
Posology: The recommended dose of upadacitinib is 15 mg once daily.
Treatment should not be initiated in patients with an absolute lymphocyte count (ALC) that is < 500 cells/mm3, an absolute neutrophil count (ANC) that is < 1,000 cells/mm3 or who have haemoglobin (Hb) levels that are < 8 g/dL (see Precautions and Adverse Reactions).
Dose interruption: Treatment should be interrupted if a patient develops a serious infection until the infection is controlled.
Interruption of dosing may be needed for management of laboratory abnormalities as described in Table 5. (See Table 5.)
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Special populations: Elderly: No dose adjustment is required in patients aged 65 years and older. There are limited data in patients aged 75 years and older.
Renal impairment: No dose adjustment is required in patients with mild or moderate renal impairment. There are limited data on the use of upadacitinib in subjects with severe renal impairment (see Pharmacology: Pharmacokinetics under Actions). Upadacitinib should be used with caution in patients with severe renal impairment. The use of upadacitinib has not been studied in subjects with end stage renal disease.
Hepatic impairment: No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment (see Pharmacology: Pharmacokinetics under Actions). Upadacitinib should not be used in patients with severe (Child Pugh C) hepatic impairment (see Contraindications).
Paediatric population: The safety and efficacy of RINVOQ in children and adolescents aged 0 to less than 18 years have not yet been established. No data are available.
Method of administration: RINVOQ is to be taken orally once daily with or without food and may be taken at any time of the day. Tablets should be swallowed whole and should not be split, crushed, or chewed.