Select therapeutic use:

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. If unable to swallow, tabs may be crushed; or can be administered via oral dispersion, G tube, NG tube or OG tube. 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): 1mg once daily. Concomitant strong OAT3 inhibitors (eg, probenecid): reduce to 1mg once daily (if recommended dose is 2mg); consider discontinuing probenecid (if recommended dose is 1mg). Dose modifications, alternative administration prep: 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 (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.

OLUMIANT Classification:

Janus kinase (JAK) inhibitor.

OLUMIANT Interactions:

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

Adverse Reactions:

RA: upper respiratory tract infections, nausea, herpes simplex, herpes zoster. COVID-19: increased liver enzymes, thrombocytosis, increased creatine phosphokinase, neutropenia, deep vein thrombosis, pulmonary embolism, UTI. Alopecia areata: upper respiratory tract infections, headache, acne, hyperlipidemia, increased creatine phosphokinase, UTI, elevated liver enzymes, folliculitus, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, increased weight. 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

Pricing for OLUMIANT

2mg tablet (Qty: 30)
Appx. price $2466
GoodRx

Miscellaneous dermatological conditions:

Indications for: OLUMIANT

Severe alopecia areata.

Limitations of Use:

Not recommended in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.

Adult Dosage:

Take with or without food. If unable to swallow, tabs may be crushed; or can be administered via oral dispersion, G tube, NG tube or OG tube. 2mg once daily; if inadequate response, may increase to 4mg once daily. For patients with nearly complete or complete scalp hair loss (with or without substantial eyelash or eyebrow hair loss): consider 4mg once daily. Moderate renal impairment (eGFR 30–60mL/min/1.73m2), concomitant strong OAT3 inhibitors (eg, probenecid): reduce to 2mg once daily (if recommended dose is 4mg); reduce to 1mg once daily (if recommended dose is 2mg). Dose modifications, alternative administration prep: 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 (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.

OLUMIANT Classification:

Janus kinase (JAK) inhibitor.

OLUMIANT Interactions:

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

Adverse Reactions:

RA: upper respiratory tract infections, nausea, herpes simplex, herpes zoster. COVID-19: increased liver enzymes, thrombocytosis, increased creatine phosphokinase, neutropenia, deep vein thrombosis, pulmonary embolism, UTI. Alopecia areata: upper respiratory tract infections, headache, acne, hyperlipidemia, increased creatine phosphokinase, UTI, elevated liver enzymes, folliculitus, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, increased weight. 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

Pricing for OLUMIANT

2mg tablet (Qty: 30)
Appx. price $2466
GoodRx

Viral infections:

Indications for: OLUMIANT

COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Adult Dosage:

Take with or without food. If unable to swallow, tabs may be crushed; or can be administered via oral dispersion, G tube, NG tube or OG tube. 4mg once daily for 14 days or until hospital discharge (whichever occurs first). Moderate renal impairment (eGFR 30–<60mL/min/1.73m2): 2mg once daily; severe renal impairment (eGFR 15–<30mL/min/1.73m2): 1mg once daily. Concomitant strong OAT3 inhibitors (eg, probenecid): reduce to 2mg once daily (if recommended dose is 4mg); reduce to 1mg once daily (if recommended dose is 2mg); consider discontinuing probenecid (if recommended dose is 1mg). Dose modifications, alternative administration prep: 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 (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.

OLUMIANT Classification:

Janus kinase (JAK) inhibitor.

OLUMIANT Interactions:

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

Adverse Reactions:

RA: upper respiratory tract infections, nausea, herpes simplex, herpes zoster. COVID-19: increased liver enzymes, thrombocytosis, increased creatine phosphokinase, neutropenia, deep vein thrombosis, pulmonary embolism, UTI. Alopecia areata: upper respiratory tract infections, headache, acne, hyperlipidemia, increased creatine phosphokinase, UTI, elevated liver enzymes, folliculitus, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, increased weight. 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

Pricing for OLUMIANT

2mg tablet (Qty: 30)
Appx. price $2466
GoodRx