Olumiant Approval History
Reviewed on Jun 5, 2018 by J.Stewart B.Pharm.
- FDA approved: Yes (First approved May 31st, 2018)
- Brand name: Olumiant
- Generic name: baricitinib
- Dosage form: Tablets
- Company: Eli Lilly and Company
- Treatment for: Rheumatoid Arthritis
Olumiant (baricitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis.
Indications and Usage
Olumiant is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.
Dosage and Administration
The recommended dose of Olumiant is 2 mg once daily, and may be used as monotherapy or in combination with methotrexate or other DMARDs.
Warnings and Precautions
Olumiant is approved with a Boxed Warning for the risk of serious infections, malignancies and thrombosis.
Common adverse reactions (greater than or equal to 1%) include: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
Development History and FDA Approval Process for Olumiant
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