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 recommended for patients at higher risk of venous thromboembolism (VTE), major adverse cardiovascular events (MACE) and malignancy,
for patients aged ≥65 years and for patients with a history of chronic or recurrent infections (see Precautions). A dose of 4 mg once daily may be considered for patients who do not achieve adequate control of disease activity with 2 mg once daily dose. 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).
Atopic dermatitis: Adults: The recommended dose of baricitinib is 4 mg once daily. A dose of 2 mg once daily is recommended for patient at higher risk of VTE, MACE and malignancy, for patients aged ≥65 years and for patients with a history of chronic or recurrent infections (see Precautions). A dose of 4 mg once daily may be considered for patients who do not achieve adequate control of disease activity with 2 mg once daily dose. 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.
Children and adolescents (2 years of age and older): The recommended dose of baricitinib is 4 mg once daily for patients weighing 30 kg or more. For patients weighing 10 kg to less than 30 kg, the recommended dose is 2 mg once daily.
Baricitinib can be used with or without topical corticosteroids. 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 is recommended for patients at higher risk of VTE, MACE and malignancy, for patients aged ≥65 years and for patients with a history of chronic or recurrent infections (see Precautions). A dose of 4 mg once daily may be considered for patients who do not achieve adequate control of disease activity with 2 mg once daily dose. 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).
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.
Juvenile idiopathic arthritis (from 2 to less than 18 years of age): The recommended dose of baricitinib is 4 mg once daily for patients weighing 30 kg or more. For patients weighing 10 kg to less than 30 kg, the recommended dose is 2 mg once daily.
Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit after 12 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).
Dose reduction: In patients taking strong Organic Anion Transporter 3 (OAT3) inhibitors such as probenecid, or with creatinine clearance between 30 and 60 mL/min the recommended dose should be reduced by half for paediatric patients and the recommended dose is 2 mg for adult patients (see Interactions). An appropriate dose strength is not available for children weighing less than 30 kg taking OAT3 inhibitors or with moderate renal impairment. Do not exceed 1 mg once daily for these patients.
Special populations: Renal impairment: The recommended dose is 2 mg once daily in adult patients with creatinine clearance between 30 and 60 mL/min. In paediatric patients with creatinine clearance between 30 and 60 mL/min, the recommended dose of baricitinib should be reduced by half. Baricitinib is not recommended for use in patients with creatinine clearance <30 mL/min (see Pharmacology: Pharmacokinetics under Actions). An appropriate dose strength is not available for children weighing less than 30 kg taking OAT3 inhibitors or with moderate renal impairment. Do not exceed 1 mg once daily for these patients.
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.
Paediatric population (less than 2 years): The safety and efficacy of Baricitinib in children less than 2 years have not yet been established. No data are available. See previously mentioned information on posology in children aged 2 years and older.
The safety and efficacy of baricitinib in children less than 18 years of age with alopecia areata 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.
Alternative administration for children: For paediatric patients who are unable to swallow whole tablets, it may be considered to disperse the tablets in water. Only water should be used to disperse the tablet. Only the number of tablets needed for the dose should be dispersed.
If for any reason the entire suspension is not administered, do not disperse and administer another tablet but wait until the next scheduled dose.
For instructions on dispersion of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.