Rinvoq Dosage/Direction for Use

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 Adverse Reactions and Pharmacology: Pharmacodynamics under Actions). 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 Interactions).
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 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 23. (See Table 23.)

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Special Populations: Elderly: For atopic dermatitis, doses higher than 15 mg once daily are not recommended in patients aged 65 years and older (see Adverse Reactions).
For ulcerative colitis, doses higher than 15 mg once daily for maintenance therapy are not recommended in patients aged 65 years and older (see Adverse Reactions). 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 Pharmacology: Pharmacokinetics under Actions). 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 24. The use of upadacitinib has not been studied in subjects with end stage renal disease. (See Table 24.)

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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: 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 Pharmacology: Pharmacokinetics under Actions).
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.