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Baricitinib
Olumiant® (baricitinib) tablets
1mg, 2mg, 4mgbaricitinib
1mg, 2mg, 4mgThis information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What is the recommended dose and method of administration of Olumiant® (baricitinib) for the treatment of adult patients with severe alopecia areata?
The recommended dosage of baricitinib for the treatment of severe AA is 2 mg daily. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4 mg daily.
See important safety information, including boxed warning, in the attached prescribing information.
Dosing of Baricitinib
The recommended dosage of baricitinib for the treatment of adult patients with severe alopecia areata (AA) is 2 mg once daily. Increase to 4 mg once daily if the response to treatment is not adequate.1
For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4 mg once daily.1
Once patients achieve an adequate response to treatment with 4 mg, decrease the dosage to 2 mg once daily.1
Dosage Modifications
Dosage modifications are recommended in patients with renal impairment (Baricitinib Dosage in Adult Patients with Alopecia Areata and Renal Impairment) and in patients taking strong organic anion transporter 3 inhibitors (Baricitinib Dosage in Adult Patients Taking Strong Organic Anion Transporter 3 Inhibitors).1
Renal Impairment Stage |
Estimated Glomerular Filtration Rate |
Baricitinib Dosage in Adult Patients with Alopecia Areata |
|
If the recommended dosage is 2 mg once daily |
If the recommended dosage is 4 mg once daily |
||
Mild |
60 to <90 |
Maintain dosage |
Maintain Dosage |
Moderate |
30 to <60 |
Reduce to 1 mg once daily |
Reduce to 2 mg once daily |
Severe |
<30 |
Not recommended |
Not recommended |
Drug Interaction |
Baricitinib Dosage in Adult Patients with Alopecia Areata |
|
If the recommended dosage is 2 mg once daily |
If the recommended dosage is 4 mg once daily |
|
Patients taking strong OAT3 inhibitorsa |
Reduce to 1 mg once daily |
Reduce to 2 mg once daily |
Abbreviation: OAT3 = organic anion transporter 3.
aBaricitinib exposure is increased when co-administered with strong OAT3 inhibitors (such as probenecid), hence the dosage of baricitinib should be reduced by half the recommended dose.
No dose adjustment is necessary in patients with mild or moderate hepatic impairment. Baricitinib has not been studied in patients with severe hepatic impairment and is therefore not recommended.1
Method of Administration
Route of Administration
Baricitinib is given orally with or without food.1
Timing
An assessment of food effects in healthy subjects showed that a high-fat meal decreased the mean AUC and Cmax of baricitinib by approximately 11% and 18%, respectively, and delayed the tmax by 0.5 hours. Administration with meals is not associated with a clinically relevant effect on exposure. In clinical studies, baricitinib was administered without regard to meals.1
Use With Other Alopecia Areata Therapies
The following combinations with baricitinib have not been studied in patients with AA and are not recommended, including
- biologic immunomodulators
- other janus kinase (JAK) inhibitors
- cyclosporine, or
- other potent immunosuppressants.1
Enclosed Prescribing Information
References
1Olumiant [package insert]. Indianapolis, IN: Eli Lilly and Company; 2022.
Date of Last Review: March 31, 2022