RINVOQ EXTENDED-RELEASE TABLET 45MG

TABLET, FILM COATED, EXTENDED RELEASE

**4.2 Posology and method of administration** Treatment with upadacitinib should be initiated and supervised by physicians experienced in the diagnosis and treatment of conditions for which upadacitinib is indicated. Posology Rheumatoid Arthritis, Psoriatic Arthritis, Non-radiographic Axial Spondyloarthritis and Ankylosing Spondylitis The recommended dose of upadacitinib is 15 mg once daily. Atopic Dermatitis _Adults_ The recommended dose of upadacitinib is 15 mg once daily for adults. A dose of 30 mg once daily may be considered for patients with high disease burden or for patients with an inadequate response to 15 mg once daily, if clinically warranted and based on benefit-risk assessment. The lowest effective dose for maintenance should be used. For patients ≥ 65 years of age, the recommended dose of upadacitinib is 15 mg once daily. _Adolescents (from 12 to 17 years of age)_ The recommended dose of upadacitinib is 15 mg once daily for adolescents weighing at least 30 kg. _Concomitant Topical Therapies_ Upadacitinib can be used with or without topical corticosteroids. Topical calcineurin inhibitors may be used for sensitive areas such as the face, neck, and intertriginous and genital areas. Consideration should be given to discontinuing upadacitinib treatment in any patient who shows no evidence of therapeutic benefit after 12 weeks of treatment. Ulcerative Colitis _Induction_ The recommended induction dose of upadacitinib is 45 mg once daily for 8 weeks. For patients who do not achieve adequate therapeutic benefit by Week 8, upadacitinib 45 mg once daily may be continued for an additional 8 weeks (see sections 4.8 and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Upadacitinib should be discontinued in any patient who shows no evidence of therapeutic benefit by week 16. _Maintenance_ The recommended maintenance dose of upadacitinib is 15 mg or 30mg once daily based on individual patient presentation: - A dose of 30 mg once daily may be appropriate for some patients, such as those with high disease burden (e.g. severe disease, pancolitis) or requiring 16-week induction treatment. - A dose of 30 mg once daily may be appropriate for patients who do not show adequate therapeutic benefit to 15 mg once daily. - The lowest effective dose for maintenance should be used. For patients ≥ 65 years of age, the recommended maintenance dose is 15 mg once daily. In patients who have responded to treatment with upadacitinib, corticosteroids may be reduced and/or discontinued in accordance with standard of care. _Interactions_ For patients with ulcerative colitis receiving strong inhibitors of cytochrome P450 (CYP) 3A4 (e.g., ketoconazole, clarithromycin), the recommended induction dose is 30 mg once daily and the recommended maintenance dose is 15 mg once daily (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Dose Initiation_ Treatment should not be initiated in patients with an absolute lymphocyte count (ALC) that is < 0.5 x 109 cells/L, an absolute neutrophil count (ANC) that is < 1 x 109 cells/L or who have haemoglobin (Hb) levels that are < 8 g/dL (see sections 4.4 and 4.8 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _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 1.  Special Populations _Elderly_ For atopic dermatitis, doses higher than 15 mg once daily are not recommended in patients aged 65 years and older (see Section 4.8 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). For ulcerative colitis, doses higher than 15 mg once daily for maintenance therapy are not recommended in patients aged 65 years and older (see section 4.8 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The safety and efficacy of upadacitinib in patients aged 75 and older have not yet been established. 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 section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Upadacitinib should be used with caution in patients with severe renal impairment (estimated glomerular filtration rate (eGFR) 15 to < 30 ml/min/1.73m2) as described in Table 2. 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 section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Upadacitinib should not be used in patients with severe (Child Pugh-C) hepatic impairment (see section 4.3). _Paediatric Population_ Atopic Dermatitis The safety and efficacy of RINVOQ in children with atopic dermatitis below the age of 12 years have not been established. No data are available. No clinical exposure data are available in adolescents < 40 kg (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Rheumatoid Arthritis, Psoriatic Arthritis, Non-radiographic Axial Spondyloarthritis, Ankylosing Spondylitis, Ulcerative Colitis 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 in order to ensure the entire dose is delivered correctly. Missed Dose If a dose of RINVOQ is missed and it is more than 10 hours from the next scheduled dose, advise the patient to take a dose as soon as possible and then to take the next dose at the usual time. If a dose is missed and it is less than 10 hours from the next scheduled dose, advise the patient to skip the missed dose and take only a single dose as usual the following day. Advise the patient not to double a dose to make up for a missed dose.