Important: Barigen 4 mg is not automatically the correct dose for every indication.
The current U.S. prescribing information demonstrates why dose must be linked to the specific indication.
U.S. labeled adult doses
| Indication | Current U.S. labeled regimen |
|---|---|
| Rheumatoid arthritis | 2 mg once daily |
| COVID-19 in hospitalized adults | 4 mg once daily for up to 14 days or until hospital discharge, whichever comes first |
| Severe alopecia areata | 2 mg once daily; may increase to 4 mg once daily when response is inadequate or in specified patients |
Therefore, Barigen 4 mg should not be marketed as a universal daily dose of baricitinib.
Rheumatoid arthritis
The current U.S. labeled dose for rheumatoid arthritis is 2 mg once daily.
COVID-19
For hospitalized adults meeting the labeled respiratory-support criteria, the current U.S. dose is 4 mg once daily for up to 14 days or until hospital discharge, whichever occurs first.
Alopecia areata
The U.S. label recommends 2 mg once daily and permits increasing to 4 mg once daily when response is inadequate.
For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow loss, 4 mg once daily may be considered. Once adequate response is achieved with 4 mg, the dose can be decreased to 2 mg once daily.
Kidney function
Renal function affects baricitinib dosing.
The current U.S. label does not recommend baricitinib for RA or alopecia areata in patients with eGFR below 30 mL/min/1.73 m² and has additional restrictions for COVID-19 patients with severe renal impairment, dialysis, ESRD or acute kidney injury.
Liver impairment
Dose recommendations also depend on hepatic status and the treatment indication.
Drug interactions
Certain medicines can affect baricitinib exposure. Dose adjustments may therefore be required depending on the interacting medicine.
Administration
Baricitinib is administered orally and may be taken with or without food.
The complete prescribing information should guide all patient-specific dose decisions.