Arthritis/rheumatic disorders:

Indications for: OLUMIANT

Moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response to 1 or more TNF blockers.

Limitations of Use:

Not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (eg, azathioprine, cyclosporine).

Adult Dosage:

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.

Children Dosage:

Not established.

Boxed Warning:

Serious infections. Mortality. Malignancy. Major adverse cardiovascular events (MACE). Thrombosis.

OLUMIANT Warnings/Precautions:

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. Screen for viral hepatitis before starting therapy. RA patients age ≥50yrs with ≥1 CV risk factor treated with another JAK inhibitor: increased rate of all-cause mortality (including sudden CV death), MACE (CV death, MI, stroke), or thrombosis. Discontinue in those with previous MI or stroke, or with symptoms of thrombosis. Avoid in those with increased risk for thrombosis. Increased rate of malignancies (esp. lymphomas, lung cancers). Consider benefits/risks prior to or continuing therapy (esp. smokers, with other CV risk factors, or with a known malignancy). Perform periodic skin exam in those with skin cancer risk. GI perforations risk (eg, history of diverticulitis). Update immunizations based on current guidelines prior to initiation. 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. Discontinue and evaluate if a serious hypersensitivity reaction occurs. Severe renal impairment (eGFR <30mL/min/1.73m2) or severe hepatic impairment: not recommended. Elderly: monitor renal function. Pregnancy. Nursing mothers: not recommended.

OLUMIANT Classification:

Janus kinase (JAK) inhibitor.

OLUMIANT Interactions:

Avoid concomitant live vaccines. Potentiated by strong OAT3 inhibitors (eg, probenecid); see Adult dose.

Adverse Reactions:

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.

Generic Drug Availability:

NO

How Supplied:

Tabs—30