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The recommended dose of baricitinib is 4 mg once daily. For patients at increased risk of venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and malignancy, patients aged ≥65 years, and patients with a history of chronic or recurrent infections, the recommended dose is 2 mg once daily.
If the 2 mg once-daily dose fails to adequately control disease activity, a dose of 4 mg once daily may be considered. For patients who achieve sustained control of disease activity with the 4 mg once-daily dose and meet the criteria for dose reduction, switching to the 2 mg once-daily dose should be considered.
The recommended dose of baricitinib is 4 mg once daily. For patients at increased risk of VTE, MACE, and malignancy, patients aged ≥65 years, and patients with a history of chronic or recurrent infections, the recommended dose is 2 mg once daily.
If the 2 mg once-daily dose fails to adequately control disease activity, a dose of 4 mg once daily may be considered. For patients who achieve sustained control of disease activity with the 4 mg once-daily dose and meet the criteria for dose reduction, switching to the 2 mg once-daily dose should be considered.
Baricitinib may be used with or without topical corticosteroids. Concomitant use with topical corticosteroids may enhance the efficacy of baricitinib. Topical calcineurin inhibitors may be used, but should be restricted to sensitive areas such as the face, neck, intertriginous areas, and genital regions.
Treatment should be considered for discontinuation in patients who show no evidence of therapeutic benefit after 8 weeks of treatment.
For patients weighing 30 kg or more, the recommended dose of baricitinib is 4 mg once daily. For patients weighing 10 kg to less than 30 kg, the recommended dose is 2 mg once daily.
For patients who achieve sustained control of disease activity with the recommended dose and meet the criteria for dose reduction, halving the dose should be considered.
Baricitinib may be used with or without topical corticosteroids. Topical calcineurin inhibitors may be used, but should be restricted to sensitive areas such as the face, neck, intertriginous areas, and genital regions.
Treatment should be considered for discontinuation in patients who show no evidence of therapeutic benefit after 8 weeks of treatment.
The recommended dose of baricitinib is 4 mg once daily. For patients at increased risk of VTE, MACE, and malignancy, patients aged ≥65 years, and patients with a history of chronic or recurrent infections, the recommended dose is 2 mg once daily.
If the 2 mg once-daily dose fails to adequately control disease activity, a dose of 4 mg once daily may be considered. For patients who achieve sustained control of disease activity with the 4 mg once-daily dose and meet the criteria for dose reduction, switching to the 2 mg once-daily dose should be considered.
After achieving a stable response, continued treatment for at least several months is recommended to prevent relapse. The benefit-risk profile of treatment should be reassessed regularly on an individual basis.
Treatment should be considered for discontinuation in patients who show no evidence of therapeutic benefit after 36 weeks of treatment.
For patients weighing 30 kg or more, the recommended dose of baricitinib is 4 mg once daily. For patients weighing 10 kg to less than 30 kg, the recommended dose is 2 mg once daily.
Treatment should be considered for discontinuation 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) below 0.5×10^9 cells/L, an absolute neutrophil count (ANC) below 1×10^9 cells/L, or a hemoglobin level below 8 g/dL. Initiation of treatment may be considered once these values improve to above the aforementioned limits.
For patients taking strong organic anion transporter 3 (OAT3) inhibitors (e.g., probenecid) or with a creatinine clearance (CrCl) between 30 and 60 mL/min:
The recommended dose for pediatric patients should be halved.
The recommended dose for adult patients is 2 mg once daily.
For adult patients with a CrCl between 30 and 60 mL/min, the recommended dose is 2 mg once daily.
For pediatric patients with a CrCl between 30 and 60 mL/min, the recommended dose of baricitinib should be halved.
Use of baricitinib is not recommended in patients with a CrCl <30 mL/min.
No dose adjustment is required for patients with mild or moderate hepatic impairment. Use of baricitinib is not recommended in patients with severe hepatic impairment.
Clinical experience in patients aged ≥75 years is very limited.
Pediatric Population (Aged Less Than 2 Years)
The safety and efficacy of baricitinib in children aged less than 2 years have not been established. No data are available.
The safety and efficacy of baricitinib in children aged less than 18 years with alopecia areata have not been established. No data are available.
Oral administration.
Baricitinib is taken once daily, with or without food, and may be administered at any time of the day.
For pediatric patients unable to swallow intact tablets, the tablets may be considered for dispersion in water. Only water should be used to disperse the tablets. Only the number of tablets needed for the required dose should be dispersed.
If the entire suspension is not taken for any reason, do not disperse and take another tablet; instead, wait until the next scheduled dose time.
FDA，2025.01
