Olumiant

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 (except those with COVID-19). 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 (in those with RA or alopecia areata). Avoid initiation or interrupt therapy (in those with RA or alopecia areata) if ALC <500cells/mm³, ANC <1000cells/mm³, or hemoglobin <8g/dL. Avoid initiation or interrupt therapy (in those with COVID-19) if ALC <200cells/mm³ or ANC <500cells/mm³. Monitor CBCs, renal, and hepatic function at baseline and during therapy. 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. RA, alopecia areata: severe renal impairment (eGFR <30mL/min/1.73m²) or severe hepatic impairment: not recommended. COVID-19: ESRD, on dialysis, or acute kidney injury (eGFR <15mL/min/1.73m²): not recommended; severe hepatic impairment: use only if benefit outweighs risk. Elderly: monitor. Pregnancy. Nursing mothers: not recommended.

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 (except those with COVID-19). 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 (in those with RA or alopecia areata). Avoid initiation or interrupt therapy (in those with RA or alopecia areata) if ALC <500cells/mm³, ANC <1000cells/mm³, or hemoglobin <8g/dL. Avoid initiation or interrupt therapy (in those with COVID-19) if ALC <200cells/mm³ or ANC <500cells/mm³. Monitor CBCs, renal, and hepatic function at baseline and during therapy. 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. RA, alopecia areata: severe renal impairment (eGFR <30mL/min/1.73m²) or severe hepatic impairment: not recommended. COVID-19: ESRD, on dialysis, or acute kidney injury (eGFR <15mL/min/1.73m²): not recommended; severe hepatic impairment: use only if benefit outweighs risk. Elderly: monitor. Pregnancy. Nursing mothers: not recommended.

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 (except those with COVID-19). 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 (in those with RA or alopecia areata). Avoid initiation or interrupt therapy (in those with RA or alopecia areata) if ALC <500cells/mm³, ANC <1000cells/mm³, or hemoglobin <8g/dL. Avoid initiation or interrupt therapy (in those with COVID-19) if ALC <200cells/mm³ or ANC <500cells/mm³. Monitor CBCs, renal, and hepatic function at baseline and during therapy. 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. RA, alopecia areata: severe renal impairment (eGFR <30mL/min/1.73m²) or severe hepatic impairment: not recommended. COVID-19: ESRD, on dialysis, or acute kidney injury (eGFR <15mL/min/1.73m²): not recommended; severe hepatic impairment: use only if benefit outweighs risk. Elderly: monitor. Pregnancy. Nursing mothers: not recommended.