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Olumiant ® ▼ (baricitinib)
Olumiant®▼(baricitinib): Dosing for Moderate to Severe Rheumatoid Arthritis
The recommended dose for baricitinib (BARI) in adult patients with moderately to severely active rheumatoid arthritis is 4 mg once daily.
The recommended dose of baricitinib is 4 mg once daily.1
For some patients, a dose of 2 mg once daily may be acceptable.1
- The recommended dose of BARI in patients with eGFR between 30 and 60 mL/min/1.73 m2 is 2 mg once daily. 1
- The recommended dose of BARI in patients taking OAT3 inhibitors with a strong inhibition potential, such as probenecid, is 2 mg once daily.1
- Clinical experience in patients ≥ 75 years is very limited and in these patients a starting dose of 2 mg is appropriate.1
A dose of 2 mg once daily may be appropriate for patients with a history of chronic or recurrent infections.
A dose of 2 mg once daily may also be considered for patients who have achieved sustained control of disease activity with 4 mg once daily and are eligible for dose tapering.1
Use of BARI is not recommended in patients with
- estimated glomerular filtration rate of < 30 mL/min/1.73 m2.
- severe hepatic impairment
- absolute lymphocyte count <500 cells/mm3
- absolute neutrophil count <1000 cells/mm3, or
- hemoglobin level <8 g/dL.2
Use of BARI is not recommended in pediatric patients.1
Route of Administration
Baricitinib is for oral use.1
Baricitinib is to be taken once daily with or without food and may be taken at any time of the day.1
Administration with meals is not associated with a clinically relevant effect on exposure.2
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.2
In clinical studies, BARI was administered without regard to meals.2
Baricitinib can be taken at any time of day or night. It is best to take BARI at the same time every day.1
Use With Other RA Therapies
Baricitinib may be used as monotherapy or in combination with methotrexate.1
Limitation of Use
- biologic DMARDs
- biologic immunomodulators or
- other Janus kinase (JAK) inhibitors
is not recommended, as a risk of additive immunosuppression cannot be excluded.1
In rheumatoid arthritis, data concerning use of baricitinib with potent immunosuppressive medicinal products, e.g.
are limited and caution should be exercised when using such combinations.1
1Olumiant [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
BARI = baricitinib
DMARD = disease-modifying antirheumatic drug
eGFR = estimated glomerular filtration rate
JAK = Janus kinase
OAT = organic anion transporter
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Date of Last Review: April 30, 2019