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  1. Medical Information Right
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  4. What is the recommended dose and method of administration of Olumiant® (baricitinib) for the treatment of adult patients with severe alopecia areata?
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Baricitinib

Olumiant® (baricitinib) tablets

1mg, 2mg, 4mg
Full Prescribing Information

baricitinib

1mg, 2mg, 4mg

HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter

This 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.

US_cFAQ_BAR010C_DOSING_AA
US_cFAQ_BAR010C_DOSING_AA
en-US

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

Baricitinib Dosage in Adult Patients with Alopecia Areata and Renal Impairment1

Renal Impairment Stage

Estimated Glomerular Filtration Rate
(eGFR; mL/minute/1.73 m2)

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

Baricitinib Dosage in Adult Patients Taking Strong Organic Anion Transporter 3 Inhibitors1

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

OLUMIANT® (baricitinib) tablets, for oral use, Lilly

References

1Olumiant [package insert]. Indianapolis, IN: Eli Lilly and Company; 2022.

Date of Last Review: March 31, 2022

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