FDA approved Olumiant (baricitinib) for Moderately to Severely Active Rheumatoid ArthritisFDA approved New Once-Daily Pill for Tough Rheumatoid Arthritis Cases

Baricitinib is a Janus kinase (JAK) inhibitor. The exact mechanism of action in rheumatoid arthritis is not fully elucidated in the label.

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 blockers. Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.

The recommended dosage is 2 mg once daily orally, with or without food. Olumiant may be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs. Avoid initiation or interrupt therapy in patients with anemia (hemoglobin <8 g/dL), lymphopenia (absolute lymphocyte count <500 cells/mm3), or neutropenia (absolute neutrophil count <1000 cells/mm3). Dosage modifications are recommended for renal or hepatic impairment, or cytopenias; see full prescribing information.

Trial data not available in label.

Prior to treatment initiation, consider performing evaluations for active and latent tuberculosis (TB) infection; Olumiant should not be given to patients with active TB. If latent infection is positive, consider treatment for TB prior to use. Viral hepatitis screening should be performed in accordance with clinical guidelines. Complete blood count should be assessed at baseline and monitored during treatment; initiation is not recommended in patients with absolute lymphocyte count <500 cells/μl, absolute neutrophil count <1000 cells/μl, or hemoglobin <8 g/dL. Baseline hepatic and renal function should be assessed and monitored. In patients with rheumatoid arthritis, update immunizations in agreement with current immunization guidelines. Other warnings and precautions are detailed in the full prescribing information.

Olumiant is an oral JAK inhibitor indicated for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF blockers. It may be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs. It is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants.