OLUMIANT® (baricitinib): Dosing for Moderate to Severe Rheumatoid Arthritis

Olumiant Prescribing Information

See important safety information, including boxed warning, in the attached prescribing information.

Dosing Considerations in Patients with Rheumatoid Arthritis

The recommended dose of BARI is 2mg once daily for patients with moderately to severely active RA who have had an inadequate response to one or more TNF antagonist therapies.¹

In patients with moderate renal impairment (estimated glomerular filtration rate between 30 and 60 mL/min/1.73 m2), the recommended dose of BARI is 1 mg once daily. ¹

In patients taking strong OAT3 inhibitors, such as probenecid, the recommended dose of OLUMIANT is 1 mg once daily.¹

Limitations of Use

Use of BARI is not recommended in patients with

• severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73m²)

• severe hepatic impairment

• active, serious infection, including localized infections

• absolute lymphocyte count <500 cells/mm³

• absolute neutrophil count <1000 cells/mm³, or

• hemoglobin level <8 g/dL.¹

Dose Administration

Route of Administration

The appropriate dose of BARi is given orally once daily.¹

Food Effects

Administration with meals is not associated with a clinically relevant effect on exposure.¹

An assessment of food effects in healthy subjects showed that a high-fat meal decreased the mean area under the curve and maximum serum concentration of BARI by approximately 11% and 18%, respectively, and delayed the time to reach maximum serum concentration by 0.5 hours.¹

In clinical studies, BARI was administered without regard to meals.¹

Timing

Baricitinib can be taken at any time of day or night. It is best to take BARI at the same time every day.^1,2

Use With Other RA Therapies

Baricitinib may be used as monotherapy or in combination with MTX or other DMARDs.¹

Use of BARI is not recommended in combination with

• other Janus kinase inhibitors

• biologic DMARDs, or

• potent immunosuppressents, such as azathioprine and cyclosporine.¹

Enclosed Prescribing Information

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

Reference

1. Olumiant [package insert]. Indianapolis, IN: Eli Lilly and Company; 2019.

2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

BARI = baricitinib

DMARD = disease-modifying antirheumatic drug

MTX = methotrexate

OAT = organic anion transporter