Olumiant Dosage/Direction for Use

Treatment should be initiated by physicians experienced in the diagnosis and treatment of the conditions for which this medicinal product is indicated.
Posology: Rheumatoid arthritis: The recommended dose of baricitinib is 4 mg once daily. A dose of 2 mg once daily is appropriate for patients such as those aged ≥ 75 years and may be appropriate for patients with a history of chronic or recurrent infections. A dose of 2 mg once daily may also be considered for patients who have achieved sustained control of disease activity with 4 mg once daily and are eligible for dose tapering (see Pharmacology: Pharmacodynamics under Actions).
Atopic dermatitis: The recommended dose of baricitinib is 4 mg once daily. A dose of 2 mg once daily is appropriate for patients such as those aged ≥ 75 years and may be appropriate for patients with a history of chronic or recurrent infections. A dose of 2 mg once daily should be considered for patients who have achieved sustained control of disease activity with 4 mg once daily and are eligible for dose tapering (see Pharmacology: Pharmacodynamics under Actions).
Baricitinib can be used with or without topical corticosteroids. The efficacy of baricitinib can be enhanced when given with topical corticosteroids (see Pharmacology: Pharmacodynamics under Actions). Topical calcineurin inhibitors may be used, but should be reserved for sensitive areas only, such as the face, neck, intertriginous and genital areas.
Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit after 8 weeks of treatment.
Alopecia areata: The recommended dose of baricitinib is 4 mg once daily. A dose of 2 mg once daily may be appropriate for patients such as those aged ≥ 75 years and for patients with a history of chronic or recurrent infections. A dose of 2 mg once daily may also be considered for patients who have achieved sustained control of disease activity with 4 mg once daily and are eligible for dose tapering (see Pharmacology: Pharmacodynamics under Actions).
Once a stable response has been achieved, it is recommended to continue treatment for at least several months, in order to avoid relapse. The benefit-risk of treatment should be re-assessed at regular intervals on an individual basis.
Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit after 36 weeks of treatment.
Treatment initiation: Treatment should not be initiated in patients with an absolute lymphocyte count (ALC) less than 0.5 x 10⁹ cells/L, an absolute neutrophil count (ANC) less than 1 x 10⁹ cells/L, or who have a haemoglobin value less than 8 g/dL. Treatment may be initiated once values have improved above these limits (see Precautions).
Co-administration with OAT3 inhibitors: The recommended dose is 2 mg once daily in patients taking Organic Anion Transporter 3 (OAT3) inhibitors with a strong inhibition potential, such as probenecid (see Interactions).
Special populations: Renal impairment: The recommended dose is 2 mg once daily in patients with creatinine clearance between 30 and 60 mL/min. Baricitinib is not recommended for use in patients with creatinine clearance < 30 mL/min (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment is required in patients with mild or moderate hepatic impairment. Baricitinib is not recommended for use in patients with severe hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Elderly: Clinical experience in patients ≥ 75 years is very limited and in these patients a starting dose of 2 mg is appropriate.
Paediatric population: The safety and efficacy of Baricitinib in children and adolescents aged 0 to 18 years have not yet been established. No data are available.
Method of administration: Oral use.
Baricitinib is to be taken once daily with or without food and may be taken at any time of the day.