Active Ingredient: Baricitinib
Baricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic DMARDs:
Baricitinib may be used as monotherapy or in combination with methotrexate.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient age in years is ≥ 2 and patient weight is ≥ 30 kg, oral, 4 milligrams baricitinib, once daily.
Regimen B: In case that patient age in years is ≥ 2 and patient weight is ≥ 10 kg and patient weight is < 30 kg, oral, 2 milligrams baricitinib, once daily.
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 should not be initiated in patients with an absolute lymphocyte count (ALC) less than 0.5 × 109 cells/L, an absolute neutrophil count (ANC) less than 1 × 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.
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.
Baricitinib is to be taken once daily with or without food and may be taken at any time of the day.
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