Active Ingredient: Baricitinib
Baricitinib is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Oral, 2 milligrams baricitinib, once daily.
Regimen B: Oral, 4 milligrams baricitinib, once daily.
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. 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.
Baricitinib can be used with or without topical corticosteroids. The efficacy of baricitinib can be enhanced when given with 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.
Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients 65 years of age and older, as observed in a large randomised study of tofacitinib (another JAK inhibitor), baricitinib should only be used in these patients if no suitable treatment alternatives are available.
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 is 2 mg.
Clinical experience in patients aged ≥75 years is very limited.
Baricitinib is to be taken once daily with or without food and may be taken at any time of the day.
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. A reduction to half the dose should be considered for patients who have achieved sustained control of disease activity with the recommended dose and are eligible for dose tapering.
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.
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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