Baricitinib

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 OLUMIANT® (baricitinib) dose for the treatment of rheumatoid arthritis?

The dosing regimen for Olumiant (baricitinib) in adult patients with moderately to severely active rheumatoid arthritis is 2 mg once daily.

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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 for baricitinib (BARI) in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers is 2 mg once daily with or without food.1
  • In patients with moderate renal impairment (estimated glomerular filtration rate (eGFR) between 30 and 60 mL/min/1.73 m2), the recommended dose of BARI is 1 mg once daily.1
  • In patients taking strong organic anion transporter 3 inhibitors, such as probenecid, the recommended dose of BARI is 1 mg once daily.1

Limitations of Use

Use of BARI is not recommended in patients with

  • severe renal impairment (eGFR <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 Rheumatoid Arthritis Therapies

Baricitinib may be used as monotherapy or in combination with methotrexate or other disease-modifying antirheumatic drug (DMARDs).1

Use of BARI is not recommended in combination with

  • other Janus kinase inhibitors
  • biologic DMARDs, or
  • potent immunosuppressants, such as azathioprine and cyclosporine.1

Use of Baricitinib With Vaccines

  • Avoid use of live vaccines with BARI.1
  • Update immunizations in agreement with current immunization guidelines prior to initiating BARI therapy.1

References

1Olumiant [package insert]. Indianapolis, IN: Eli Lilly and Company; 2021.

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

Date of Last Review: March 15, 2022


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