Baricitinib

OLUMIANT ® is a Janus kinase (JAK) inhibitor indicated for the treatment of: Moderately to severely active rheumatoid arthritis (RA) in adults 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. COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Severe alopecia areata (AA) in adults and pediatric patients 12 years of age and older. Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.

Baricitinib is a Janus kinase (JAK) inhibitor. JAKs are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function. Within the signaling pathway, JAKs phosphorylate and activate Signal Transducers and Activators of Transcription (STATs) which modulate intracellular activity including gene expression. Baricitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs. JAK enzymes transmit cytokine signaling through their pairing (e.g., JAK1/JAK2, JAK1/JAK3, JAK1/TYK2, JAK2/JAK2, JAK2/TYK2). In cell-free isolated enzyme assays, baricitinib had greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3.

Administration Instructions: See the full prescribing information for recommended evaluations and immunizations prior to OLUMIANT treatment. Moderately to Severely Active RA and Severe AA: Avoid initiation or interrupt OLUMIANT in patients with anemia (hemoglobin <8 g/dL), lymphopenia (ALC <500 cells/mm 3 ) or neutropenia (ANC <1000 cells/mm 3 ). COVID-19: Avoid initiation or interrupt OLUMIANT in patients with lymphopenia (ALC <200 cells/mm 3 ) or neutropenia (ANC <500 cells/mm 3 ). Recommended Dosage: Moderately to Severely Active RA: 2 mg once daily. OLUMIANT may be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs. COVID-19: 4 mg once daily for up to 14 days. Severe Alopecia Areata: 2 mg once daily. Increase to 4 mg once daily, if the response to treatment is not adequate.

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Boxed warning: Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with OLUMIANT if serious infection occurs until the infection is controlled. OLUMIANT should not be given to patients with active TB. Test for latent TB before and during therapy, except for COVID-19, treat latent TB prior to use. Hypersensitivity Reactions: Discontinue OLUMIANT if a serious hypersensitivity reaction occurs. Gastrointestinal Perforations: Monitor patients who may be at increased risk and evaluate promptly new onset of abdominal symptoms. Hypoglycemia in Patients with Diabetes: Consider increased monitoring of blood glucose, advise patients with diabetes to notify their healthcare provider if they develop signs or symptoms of hypoglycemia.

The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections Mortality Malignancy and Lymphoproliferative Disorders Major Adverse Cardiovascular Events Thrombosis Hypersensitivity Gastrointestinal Perforations Hypoglycemia in Patients with Diabetes Laboratory Abnormalities Adverse reactions reported in clinical trials (≥1%) are: Moderately to Severely Active RA: upper respiratory tract infections (URTIs), nausea, herpes simplex, and herpes zoster.

In patients taking strong Organic Anion Transporter 3 (OAT3) inhibitors (e.g., probenecid), reduce the recommended OLUMIANT dosage. Strong OAT3 Inhibitors Baricitinib exposure is increased when OLUMIANT is co-administered with strong OAT3 inhibitors (such as probenecid), hence the dosage of baricitinib should be reduced by half the recommended dose. Other JAK Inhibitors or Biologic DMARDs OLUMIANT has not been studied in combination with other JAK inhibitors or with biologic DMARDs.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).