Indications for OLUMIANT:
Moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response to 1 or more tumor necrosis factor (TNF) antagonists.
Limitations of Use:
Not recommended for use with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (eg, azathioprine, cyclosporine).
Take with or without food. 2mg once daily. May be used as monotherapy or in combination with methotrexate or other DMARDs. Moderate renal impairment (eGFR 30–60mL/min/1.73m2), concomitant strong OAT3 inhibitors: 1mg once daily. Dose modifications: see full labeling.
Serious infections. Malignancy. Thrombosis.
Increased risk of serious or fatal infections (eg, TB, bacterial, viral, invasive fungal, or other opportunistic pathogens). Avoid in active, serious, or localized infections. Chronic, recurrent, or history of serious or opportunistic infections. Travel to, or residence in, areas with endemic TB or mycoses. Conditions that predispose to infection. Test/treat latent TB infection prior to and per applicable guidelines during therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of herpes virus or hepatitis occurs; interrupt treatment if serious or opportunistic infection, or sepsis develops. Known malignancy. Perform periodic skin exam in those with skin cancer risk. Thrombosis risk. GI perforations risk (eg, history of diverticulitis). Update immunization based on current guidelines prior to initiating therapy. Do not initiate therapy if lymphocytes <500 cells/mm3, ANC <1000 cells/mm3, or hemoglobin <8g/dL. Monitor lymphocytes, neutrophils, and hemoglobin at baseline, then periodically thereafter. Routinely monitor liver enzymes; interrupt therapy if ALT/AST elevated and drug-induced liver injury is suspected. Monitor lipids 12 weeks following initiation. Severe renal impairment (eGFR <30mL/min/1.73m2) or severe hepatic impairment: not recommended. Elderly: monitor renal function. Pregnancy. Nursing mothers: not recommended.
Janus kinase (JAK) inhibitor.
Avoid concomitant live vaccines. Potentiated by strong OAT3 inhibitors (eg, probenecid); see Adults.
Upper respiratory tract infections, nausea, herpes simplex, herpes zoster; other serious or opportunistic infections, TB, malignancies (eg, lymphoma), cytopenias, liver enzyme or lipid elevations, non-melanoma skin cancer, thrombosis.