HIGHLIGHTS OF PRESCRIBING INFORMATION
`These highlights do not include all the information needed to
`use OLUMIANT safely and effectively. See full prescribing
`information for OLUMIANT.
`
`OLUMIANT (baricitinib) tablets, for oral use
`Initial U.S. Approval: 2018
`WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY,
`MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and
`THROMBOSIS
`See full prescribing information for complete 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 tuberculosis. Test for latent TB before and during
`therapy, except for COVID-19; treat latent TB prior to use.
`Monitor all patients for active TB during treatment, even
`patients with initial negative, latent TB test. (5.1)
`• Higher rate of all-cause mortality, including sudden
`cardiovascular death with another Janus kinase inhibitor
`(JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients.
`(5.2)
`• Malignancies have occurred in patients treated with
`OLUMIANT. Higher rate of lymphomas and lung cancers with
`another JAK inhibitor vs. TNF blockers in RA patients. (5.3)
`• Higher rate of MACE (defined as cardiovascular death,
`myocardial infarction, and stroke) with another JAK inhibitor
`vs. TNF blockers in RA patients. (5.4)
`• Thrombosis has occurred in patients treated with OLUMIANT.
`Increased incidence of pulmonary embolism, venous and
`arterial thrombosis with another JAK inhibitor vs. TNF
`blockers. (5.5)
`
`--------------------------RECENT MAJOR CHANGES--------------------------
`Boxed Warning
`05/2022
`Indications and Usage, COVID-19 (1.2)
`05/2022
`Indications and Usage, Alopecia Areata (1.3)
`06/2022
`Dosage and Administration (2.1, 2.2, 2.3, 2.8)
`05/2022
`Dosage and Administration (2.4, 2.5, 2.6, 2.7)
`06/2022
`Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5)
`12/2021
`Warnings and Precautions (5.8)
`05/2022
`---------------------------INDICATIONS AND USAGE--------------------------
`OLUMIANT® is a Janus kinase (JAK) inhibitor indicated for:
`•
`the treatment of adult patients with moderately to severely
`active rheumatoid arthritis who have had an inadequate
`response to one or more TNF blockers. (1.1)
`Limitations of Use: Not recommended for use in combination with
`other JAK inhibitors, biologic DMARDs, or with potent
`immunosuppressants such as azathioprine and cyclosporine.
`(1.1)
`the treatment of COVID-19 in hospitalized adults requiring
`supplemental oxygen, non-invasive or invasive mechanical
`ventilation, or ECMO. (1.2)
`the treatment of adult patients with severe alopecia areata. (1.3)
`•
`Limitations of Use: Not recommended for use in combination with
`other JAK inhibitors, biologic immunomodulators, cyclosporine
`or other potent immunosuppressants. (1.3)
`----------------------DOSAGE AND ADMINISTRATION----------------------
`Administration Instructions:
`•
`See the full prescribing information for recommended
`evaluations and immunizations prior to treatment. (2.1)
`Rheumatoid Arthritis and Alopecia Areata: Avoid initiation or
`interrupt OLUMIANT in patients with anemia (hemoglobin
`<8 g/dL), lymphopenia (ALC <500 cells/mm3) or neutropenia
`(ANC <1000 cells/mm3). (2.1, 2.5, 5.8)
`COVID-19: Avoid initiation or interrupt OLUMIANT in patients
`with lymphopenia (ALC <200 cells/mm3) or neutropenia
`(ANC <500 cells/mm3). (2.1, 2.5, 5.8)
`
`•
`
`•
`
`•
`
`Reference ID: 4998371
`
`1
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`Recommended Dosage:
`Rheumatoid Arthritis:
`•
`2 mg once daily. (2.2)
`•
`OLUMIANT may be used as monotherapy or in combination
`with methotrexate or other non-biologic DMARDs. (2.2)
`COVID-19:
`•
`4 mg once daily for up to 14 days. (2.3)
`Alopecia Areata:
`•
`2 mg once daily. Increase to 4 mg once daily, if the response to
`treatment is not adequate. (2.4)
`For patients with nearly complete or complete scalp hair loss,
`with or without substantial eyelash or eyebrow hair loss,
`consider treating with 4 mg once daily. (2.4)
`Reduce the dose to 2 mg once daily when an adequate
`response has been achieved. (2.4)
`Dosage Modifications in Patients with Renal or Hepatic Impairment,
`or Cytopenias
`•
`See the full prescribing information for dosage modifications by
`indication. (2.5, 2.6, 5.8)
`---------------------DOSAGE FORMS AND STRENGTHS-------------------
`Tablets: 4 mg, 2 mg, 1 mg (3)
`---------------------------CONTRAINDICATIONS--------------------------------
`None.
`-----------------------WARNINGS AND PRECAUTIONS----------------------
`•
`Hypersensitivity: Serious reactions have been reported.
`Discontinue OLUMIANT if a serious hypersensitivity reaction
`occurs. (5.6)
`Gastrointestinal Perforations: Monitor patients who may be at
`increased risk and evaluate promptly new onset of abdominal
`symptoms. (5.7)
`Laboratory Abnormalities: Monitor for changes in lymphocytes,
`neutrophils, hemoglobin, liver enzymes, and lipids. (5.8)
`Vaccinations: Avoid use with live vaccines. (5.9)
`•
`-----------------------------ADVERSE REACTIONS------------------------------
`Adverse reactions reported in clinical trials (≥1%) are:
`•
`Rheumatoid Arthritis: upper respiratory tract infections (URTIs),
`nausea, herpes simplex, and herpes zoster. (6.1)
`COVID-19: increases of liver enzymes, thrombocytosis, creatine
`phosphokinase increases, neutropenia, deep vein thrombosis,
`pulmonary embolism, and urinary tract infection (UTI) (6.1)
`Alopecia Areata: URTIs, headache, acne, hyperlipidemia,
`creatine phosphokinase increase, UTI, liver enzyme elevations,
`folliculitis, fatigue, lower respiratory tract infections, nausea,
`genital Candida infections, anemia, neutropenia, abdominal
`pain, herpes zoster, and weight increase (6.1)
`To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly
`and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-
`FDA-1088 or www.fda.gov/medwatch.
`------------------------------DRUG INTERACTIONS-----------------------------
`In patients taking strong Organic Anion Transporter 3 (OAT3)
`inhibitors (e.g., probenecid) the recommended dosage should be
`reduced. (2.7, 7.1)
`------------------------USE IN SPECIFIC POPULATIONS--------------------
`•
`Hepatic Impairment: Not recommended in patients with RA or
`AA and severe hepatic impairment. OLUMIANT has not been
`studied in patients with COVID-19 and severe hepatic
`impairment. (2.5, 8.6)
`Renal Impairment: Not recommended in COVID-19 patients
`with eGFR <15 mL/min/1.73m2, who are on dialysis, have
`ESRD, or acute kidney injury. OLUMIANT is not recommend in
`patients with RA or AA with eGFR <30 mL/min/1.73m2. (2.6,
`8.7)
`Pregnancy: Based on animal data, may cause fetal harm. (8.1,
`8.3)
`Lactation: Advise not to breastfeed. (8.2)
`
`•
`
`See 17 for PATIENT COUNSELING INFORMATION and
`Medication Guide.
`
`•
`
`•
`
`Revised: 06/2022
`
`

`

`
`
`2
`
`6 ADVERSE REACTIONS
`6.1
`Clinical Trials Experience
`6.2
`Postmarketing Experience
`7 DRUG INTERACTIONS
`7.1
`Strong OAT3 Inhibitors
`7.2
`Other JAK Inhibitors or Biologic DMARDs
`8 USE IN SPECIFIC POPULATIONS
`8.1
`Pregnancy
`8.2
`Lactation
`8.3
`Females and Males of Reproductive Potential
`8.4
`Pediatric Use
`8.5
`Geriatric Use
`8.6
`Hepatic Impairment
`8.7
`Renal Impairment
`10 OVERDOSAGE
`11 DESCRIPTION
`12 CLINICAL PHARMACOLOGY
`12.1 Mechanism of Action
`12.2 Pharmacodynamics
`12.3 Pharmacokinetics
`13 NONCLINICAL TOXICOLOGY
`13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
`14 CLINICAL STUDIES
`14.1 Rheumatoid Arthritis
`14.2 COVID-19
`14.3 Alopecia Areata
`16 HOW SUPPLIED/STORAGE AND HANDLING
`16.1 How Supplied
`16.2 Storage and Handling
`17 PATIENT COUNSELING INFORMATION
`
` *
`
` Sections or subsections omitted from the full prescribing
`information are not listed.
`
`2.2
`2.3
`2.4
`2.5
`
`2.6
`
`FULL PRESCRIBING INFORMATION: CONTENTS*
`
`WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY,
`MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and
`THROMBOSIS
`1
`INDICATIONS AND USAGE
`1.1
`Rheumatoid Arthritis
`1.2
`Coronavirus Disease 2019 (COVID-19)
`1.3
`Alopecia Areata
`2 DOSAGE AND ADMINISTRATION
`2.1
`Recommended Evaluations and Immunization Prior to
`Treatment Initiation
`Dosage Recommendations in Rheumatoid Arthritis
`Dosage Recommendations in COVID-19
`Dosage Recommendations in Alopecia Areata
`Dosage Modifications Due to Infections, Cytopenias and
`Anemia
`Dosage Modifications for Patients with Renal Impairment
`or Hepatic Impairment
`Dosage Modifications Due to Drug Interactions
`Alternative Administration for Patients Unable to Swallow
`Tablets
`3 DOSAGE FORMS AND STRENGTHS
`4 CONTRAINDICATIONS
`5 WARNINGS AND PRECAUTIONS
`5.1
`Serious Infections
`5.2 Mortality
`5.3 Malignancy and Lymphoproliferative Disorders
`5.4 Major Adverse Cardiovascular Events
`5.5
`Thrombosis
`5.6
`Hypersensitivity
`5.7
`Gastrointestinal Perforations
`5.8
`Laboratory Abnormalities
`5.9
`Vaccinations
`
`2.7
`2.8
`
`Reference ID: 4998371
`
`

`

`3
`
`FULL PRESCRIBING INFORMATION
`WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR
`EVENTS (MACE), and THROMBOSIS
`
`•
`
`SERIOUS INFECTIONS
`Patients treated with OLUMIANT are at risk for developing serious infections that may lead to hospitalization
`or death [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)]. Most patients with rheumatoid
`arthritis who developed these infections were taking concomitant immunosuppressants such as methotrexate
`or corticosteroids.
`If a serious infection develops, interrupt OLUMIANT until the infection is controlled.
`Reported infections include:
`• Active tuberculosis, which may present with pulmonary or extrapulmonary disease. OLUMIANT should not
`be given to patients with active tuberculosis. Patients, except those with COVID-19, should be tested for
`latent tuberculosis before initiating OLUMIANT and during therapy. If positive, start treatment for latent
`infection prior to OLUMIANT use.
`Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal
`infections may present with disseminated, rather than localized, disease.
`• Bacterial, viral, and other infections due to opportunistic pathogens.
`The risks and benefits of treatment with OLUMIANT should be carefully considered prior to initiating therapy
`in patients with chronic or recurrent infection.
`Patients should be closely monitored for the development of signs and symptoms of infection during and
`after treatment with OLUMIANT including the possible development of tuberculosis in patients who tested
`negative for latent tuberculosis infection prior to initiating therapy [see Warnings and Precautions (5.1)].
`
`MORTALITY
`In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and
`older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor
`necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death,
`was observed with the JAK inhibitor [see Warnings and Precautions (5.2)].
`
`MALIGNANCIES
`Lymphoma and other malignancies have been observed in patients treated with OLUMIANT. In RA patients
`treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer
`(NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at
`additional increased risk [see Warnings and Precautions (5.3)].
`
`MAJOR ADVERSE CARDIOVASCULAR EVENTS
`In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK
`inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death,
`myocardial infarction, and stroke) was observed when compared with TNF blockers. Patients who are current
`or past smokers are at additional increased risk. Discontinue OLUMIANT in patients that have experienced a
`myocardial infarction or stroke [see Warnings and Precautions (5.4)].
`
`THROMBOSIS
`Thrombosis, including deep venous thrombosis and pulmonary embolism, has been observed at an increased
`incidence in patients treated with OLUMIANT compared to placebo. In addition, there were cases of arterial
`thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years
`of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of
`thrombosis was observed when compared with TNF blockers. Avoid OLUMIANT in patients at risk. Patients
`with symptoms of thrombosis should discontinue OLUMIANT and be promptly evaluated. [see Warnings and
`Precautions (5.5)].
`
`1
`1.1
`
`INDICATIONS AND USAGE
`Rheumatoid Arthritis
`
`Reference ID: 4998371
`
`

`

`4
`
`OLUMIANT® (baricitinib) is indicated for the treatment of adult patients with moderately to severely active rheumatoid
`arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
`
`Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying
`antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.
`
`Coronavirus Disease 2019 (COVID-19)
`1.2
`OLUMIANT is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring
`supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
`
`Alopecia Areata
`1.3
`OLUMIANT is indicated for the treatment of adult patients with severe alopecia areata.
`
`Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators,
`cyclosporine or other potent immunosuppressants.
`
` 2
`
`DOSAGE AND ADMINISTRATION
`
`Recommended Evaluations and Immunization Prior to Treatment Initiation
`2.1
`Prior to OLUMIANT treatment initiation, consider performing the following evaluations:
`
` •
`
` Active and latent tuberculosis (TB) infection evaluation – OLUMIANT should not be given to patients with active
`tuberculosis (TB). If latent infection is positive in patients with rheumatoid arthritis or alopecia areata, consider
`treatment for TB prior to OLUMIANT use [see Warnings and Precautions (5.1)].
`• Viral hepatitis screening in accordance with clinical guidelines [see Warnings and Precautions (5.1)].
`• Complete blood count – Assess baseline values and verify whether treatment can be initiated:
`- In patients with rheumatoid arthritis or alopecia areata, OLUMIANT initiation is not recommended in patients with
`an absolute lymphocyte count (ALC) <500 cells/µl, absolute neutrophil count (ANC) <1000 cells/µl, or
`hemoglobin level <8 g/dL.
`- In patients with COVID-19, OLUMIANT initiation is not recommended if the ALC is <200 cells/µl or if the ANC is
`<500 cells/µl.
`Monitor complete blood counts during treatment and modify dosage as recommended [see Dosage and
`Administration (2.5) and Warnings and Precautions (5.7)].
`
` •
`
` Baseline hepatic and renal function – Assess baseline values and monitor patients for laboratory changes. Modify
`dosage based on hepatic and renal impairment, and laboratory abnormalities [see Dosage and Administration (2. 5)
`and Warnings and Precautions (5.7)].
`
`
`In patients with rheumatoid arthritis or alopecia areata, update immunizations in agreement with current immunization
`guidelines [see Warnings and Precautions (5.9)].
`
`Dosage Recommendations in Rheumatoid Arthritis
`2.2
`The recommended dosage of OLUMIANT is 2 mg once daily orally, with or without food [see Clinical Pharmacology
`(12.3)]. An alternative administration for patients unable to swallow tablets may be used [see Dosage and Administration
`(2.8)]. OLUMIANT may be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs.
`
`Dosage Recommendations in COVID-19
`2.3
`The recommended dosage of OLUMIANT for adults is 4 mg once daily orally, with or without food, for 14 days or until
`hospital discharge, whichever occurs first. An alternative administration for patients unable to swallow tablets may be
`used [see Dosage and Administration (2.8)].
`
`Dosage Recommendations in Alopecia Areata
`2.4
`The recommended dosage of OLUMIANT is 2 mg once daily orally, with or without food. Increase to 4 mg once daily if the
`response to treatment is not adequate.
`
`For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss,
`consider treating with 4 mg once daily, with or without food.
`
`Once patients achieve an adequate response to treatment with 4 mg, decrease the dosage to 2 mg once daily.
`
`
`Reference ID: 4998371
`
`

`

`Dosage Modifications Due to Infections, Cytopenias and Anemia
`2.5
`Rheumatoid Arthritis and Alopecia Areata
`• Avoid use of OLUMIANT in patients with active, serious or opportunistic infection, including localized infections. If a
`patient develops a serious infection hold treatment with OLUMIANT until the infection is controlled [see Warnings and
`Precautions (5.1)].
`• Dosage modifications for patients with rheumatoid arthritis or alopecia areata and cytopenias or anemia are described
`in Table 1.
`
`
`
`5
`
`Table 1: Dosage Modifications for Cytopenias and Anemia in Patients with Rheumatoid Arthritis or Alopecia
`Areata
`Laboratory Analyte
`Value
`≥500 cells/µL
`<500 cells/µL
`≥1000 cells/µL
`<1000 cells/µL
`≥8 g/dL
`<8 g/dL
`
`Laboratory Analyte
`
`Absolute Lymphocyte Count (ALC)
`
`Absolute Neutrophil Count (ANC)
`
`Hemoglobin
`
`Recommendation
`Maintain dosage
`Interrupt OLUMIANT until ALC ≥500 cells/µL
`Maintain dosage
`Interrupt OLUMIANT until ANC ≥1000 cells/µL
`Maintain dosage
`Interrupt OLUMIANT until hemoglobin ≥8 g/dL
`
`
`COVID-19
`• Monitor patients for signs and symptoms of new infections during treatment with OLUMIANT. The risks and benefits of
`treatment with OLUMIANT in COVID-19 patients with other concurrent infections should be considered [see Warnings
`and Precautions (5.1)].
`• Dosage modifications for patients with COVID-19 and cytopenias are described in Table 2.
`
`
`Laboratory Analyte
`
`Absolute Lymphocyte Count (ALC)
`
`Absolute Neutrophil Count (ANC)
`
`Table 2: Dosage Modifications for Cytopenias in Patients with COVID-19
`Laboratory Analyte
`Value
`≥200 cells/µL
`<200 cells/µL
`≥500 cells/µL
`<500 cells/µL
`
`Recommendation
`
`Maintain dosage
`Interrupt OLUMIANT until ALC ≥200 cells/µL
`Maintain dosage
`Interrupt OLUMIANT until ANC ≥500 cells/µL
`
`Dosage Modifications for Patients with Renal Impairment or Hepatic Impairment
`
`
`2.6
`
`Rheumatoid Arthritis
`Renal Impairment
`Dosage modifications for patients with rheumatoid arthritis and renal impairment are described in Table 3.
`
`
`Table 3: Dosage Modifications for Patients with Rheumatoid Arthritis and Renal Impairment
`Estimated Glomerular Filtration Rate
`Renal Impairment Stage
`Recommendation
`(eGFR)
`60 – <90 mL/minute/1.73 m2
`30 - <60 mL/min/1.73 m2
`<30 mL/minute/1.73 m2
`
`2 mg once daily
`1 mg once daily
`Not recommended
`
`Mild
`Moderate
`Severe
`
`
`Hepatic Impairment
`• OLUMIANT is not recommended for use in patients with severe hepatic impairment.
`•
`Interrupt OLUMIANT, if increases in ALT or AST are observed and drug-induced liver injury (DILI) is suspected, until
`the diagnosis of DILI is excluded [see Warnings and Precautions (5.8)].
`
`
`COVID-19
`
`Reference ID: 4998371
`
`

`

`Renal Impairment
`• Dosage modifications for patients with COVID-19 and renal impairment are described in Table 4.
`
`
`6
`
`Table 4: Dosage Modifications for Patients with COVID-19 and Renal Impairment
`Estimated Glomerular Filtration Rate
`Renal Impairment Stage
`Recommendation
`(eGFR)
`60 - <90 mL/min/1.73m2
`30 - <60 mL/min/1.73m2
`15 - <30 mL/min/1.73m2
`<15 mL/min/1.73m2
`
`4 mg once daily
`2 mg once daily
`1 mg once daily
`Not recommended
`
`Mild
`Moderate
`Severe
`End Stage Renal Disease, Patients on
`Dialysis, or Acute Kidney Injury
`
`
`
`Hepatic Impairment
`•
`It is not known if dosage adjustment is needed in patients with COVID-19 and severe hepatic impairment. OLUMIANT
`should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the
`potential risk.
`Interrupt OLUMIANT, if increases in ALT or AST are observed and DILI is suspected, until the diagnosis of DILI is
`excluded [see Warnings and Precautions (5.8)].
`
`•
`
`
`Alopecia Areata
`Renal Impairment
`Dosage modifications for patients with alopecia areata and renal impairment are described in Table 5.
`
`
`Table 5: Dosage Modifications for Patients with Alopecia Areata and Renal Impairment
`Estimated Glomerular Filtration Rate
`Renal Impairment Stage
`Recommendation
`(eGFR)
`If the recommended
`If the recommended
`dosage is
`dosage is
`4 mg once daily
`2 mg once daily
`Maintain dosage
`Reduce to 1 mg once
`Reduce to 2 mg once
`daily
`daily
`Not recommended
`
`Mild
`
`Moderate
`
`Severe
`
`60 – <90 mL/minute/1.73 m2
`
`30 – <60 mL/min/1.73 m2
`
`<30 mL/minute/1.73 m2
`
`
`Hepatic Impairment
`• OLUMIANT is not recommended for use in patients with severe hepatic impairment.
`•
`Interrupt OLUMIANT, if increases in ALT or AST are observed and DILI is suspected, until the diagnosis of DILI is
`excluded [see Warnings and Precautions (5.8)].
`
`Dosage Modifications Due to Drug Interactions
`
`
`2.7
`
`Rheumatoid Arthritis, COVID-19 or Alopecia Areata
`The recommended dosage of OLUMIANT in patients taking strong Organic Anion Transporter 3 (OAT3) inhibitors, such
`as probenecid, are shown in Table 6 [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
`
`
`Table 6: Dosage Modifications when Coadministered with Strong OAT3 Inhibitors in Patients With Rheumatoid
`Arthritis, COVID-19 or Alopecia Areata
`Recommendation
`If the recommended dosage is 4 mg once daily, reduce dosage to 2 mg once daily.
`If the recommended dosage is 2 mg once daily, reduce dosage to 1 mg once daily.
`If the recommended dosage is 1 mg once daily, consider discontinuing probenecid.
`
`Concomitant Medication
`
`Strong OAT3 inhibitors
`(e.g., probenecid)
`
`Reference ID: 4998371
`
`

`

`7
`
`
`Alternative Administration for Patients Unable to Swallow Tablets
`2.8
`For patients who are unable to swallow whole tablets, an alternative mode of administration may be considered:
`• Oral dispersion
`• Gastrostomy tube (G tube)
`• Nasogastric tube (NG tube) or orogastric tube (OG tube)
`
`Intact tablets are not hazardous. Tablets may be crushed to facilitate dispersion. It is not known if powder from the
`crushed tablets may constitute a reproductive hazard to the preparer. If tablets are crushed, use proper control measures
`(e.g., ventilated enclosure) or personal protective equipment (i.e., N95 respirator). Dispersed tablets are stable in water for
`up to 4 hours.
`
`Preparation Instructions for Alternative Administration:
`• Oral administration of dispersed tablets in water: For patients who are unable to swallow whole tablets, 1-mg,
`2-mg, or 4-mg baricitinib tablet(s), or any combination of tablets necessary to achieve the desired dose up to
`4-mg may be placed in a container with approximately 10 mL (5 mL minimum) of room temperature water,
`dispersed by gently swirling the tablet(s) and immediately taken orally. The container should be rinsed with an
`additional 10 mL (5 mL minimum) of room temperature water and the entire contents swallowed by the patient
`(Table 7).
`
` •
`
` Administration via G tube: For patients with a G tube, 1-mg, 2-mg, or 4-mg baricitinib tablet(s), or any
`combination of tablets necessary to achieve the desired dose up to 4-mg may be placed in a container with
`approximately 15 mL (10 mL minimum) of room temperature water and dispersed with gentle swirling. Ensure
`the tablet(s) are sufficiently dispersed to allow free passage through the tip of the syringe. Withdraw entire
`contents from the container into an appropriate syringe and immediately administer through the gastric feeding
`tube. Rinse container with approximately 15 mL (10 mL minimum) of room temperature water, withdraw the
`contents into the syringe, and administer through the tube (Table 7).
`
` •
`
` Administration via NG or OG tube: For patients with a NG or OG tube, 1-mg, 2-mg, or 4-mg baricitinib
`tablet(s), or a combination of tablets necessary to achieve the desired dose up to 4-mg may be placed into a
`container with approximately 30 mL of room temperature water and dispersed with gentle swirling. Ensure the
`tablet(s) are sufficiently dispersed to allow free passage through the tip of the syringe. Withdraw the entire
`contents from the container into an appropriate syringe and immediately administer through the enteral feeding
`tube. To avoid clogging of small diameter tubes (smaller than 12 Fr), the syringe can be held horizontally and
`shaken during administration. Rinse container with a sufficient amount (minimum of 15 mL) of room
`temperature water, withdraw the contents into the syringe, and administer through the tube (Table 7).
`
`Table 7: Dispersion and Rinse Volume for Alternative Administration
`Administration via
`Dispersion Volume
`Container Rinse Volume
`Oral dispersion
`10 mL
`10 mL
`G tube
`15 mL
`15 mL
`NG tube
`or OG tube
`
`30 mL
`
`15 mL
`
`
`
` 3
`
`DOSAGE FORMS AND STRENGTHS
`
`OLUMIANT is available as debossed, film-coated tablets:
`•
`1 mg tablet contains a recessed area on each face of the tablet surface, is very light pink, round, debossed
`with “Lilly” on one side and “1” on the other.
`2 mg tablet contains a recessed area on each face of the tablet surface, is light pink, oblong, debossed with
`“Lilly” on one side and “2” on the other.
`4 mg tablet contains a recessed area on each face of the tablet surface, is medium pink, round, debossed with
`“Lilly” on one side and “4” on the other.
`
`•
`
`•
`
`CONTRAINDICATIONS
`
` 4
`
`
`None.
`
`
`Reference ID: 4998371
`
`

`

`8
`
`WARNINGS AND PRECAUTIONS
`5
`Serious Infections
`5.1
`Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic
`pathogens have been reported in patients with rheumatoid arthritis receiving OLUMIANT. The most common serious
`infections reported with OLUMIANT included pneumonia, herpes zoster, and urinary tract infection [see Adverse
`Reactions (6.1)]. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis,
`pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with OLUMIANT.
`Some patients have presented with disseminated rather than localized disease, and were often taking concomitant
`immunosuppressants such as methotrexate or corticosteroids.
`
`Avoid use of OLUMIANT in patients with an active, serious infection, including localized infections. Consider the risks and
`benefits of treatment prior to initiating OLUMIANT in patients:
`• with chronic or recurrent infection
`• who have been exposed to tuberculosis
`• with a history of a serious or an opportunistic infection
`• who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or
`• with underlying conditions that may predispose them to infection.
`
`
`In patients with rheumatoid arthritis or alopecia areata, closely monitor for the development of signs and symptoms of
`infection during and after treatment with OLUMIANT. Interrupt OLUMIANT in patients with rheumatoid arthritis or alopecia
`areata, if the patient develops a serious infection, an opportunistic infection, or sepsis. A patient who develops a new
`infection during treatment with OLUMIANT should undergo prompt and complete diagnostic testing appropriate for an
`immunocompromised patient; appropriate antimicrobial therapy should be initiated, the patient should be closely
`monitored, and OLUMIANT should be interrupted if the patient is not responding to therapy. Do not resume OLUMIANT
`until the infection is controlled.
`
`In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with OLUMIANT.
`There is limited information regarding the use of OLUMIANT in patients with COVID-19 and concomitant active serious
`infections. The risks and benefits of treatment with OLUMIANT in COVID-19 patients with other concurrent infections
`should be considered.
`
`Tuberculosis
`Evaluate patients for active infection prior to administration of OLUMIANT. OLUMIANT should not be given to patients
`with active TB.
`
`Test patients with rheumatoid arthritis or alopecia areata for latent tuberculosis. Patients with rheumatoid arthritis or
`alopecia areata and latent tuberculosis (TB) should be treated with standard antimycobacterial therapy before initiating
`OLUMIANT. Consider anti-TB therapy prior to initiation of OLUMIANT in patients with a history of latent or active TB in
`whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who
`have risk factors for TB infection. Consultation with a physician with expertise in the treatment of TB is recommended to
`aid in the decision about whether initiating anti-TB therapy is appropriate for an individual patient.
`
`During OLUMIANT use, monitor patients for the development of signs and symptoms of TB, including patients who tested
`negative for latent TB infection prior to initiating therapy.
`
`Viral Reactivation
`Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with
`OLUMIANT. If a patient develops herpes zoster, interrupt OLUMIANT treatment until the episode resolves.
`
`The impact of OLUMIANT on chronic viral hepatitis reactivation is unknown. Patients with evidence of active hepatitis B or
`C infection were excluded from clinical trials. In clinical trials in patients with rheumatoid arthritis or alopecia areata,
`patients who were positive for hepatitis C antibody but negative for hepatitis C virus RNA were permitted to enroll.
`Patients with positive hepatitis B surface antibody and hepatitis B core antibody, without hepatitis B surface antigen, were
`permitted to enroll; such patients should be monitored for expression of hepatitis B virus (HBV) DNA. Should HBV DNA be
`detected, consult with a hepatologist. Perform screening for viral hepatitis in accordance with clinical guidelines before
`starting therapy with OLUMIANT.
`
`5.2 Mortality
`In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with
`at least one cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was
`
`Reference ID: 4998371
`
`

`

`9
`
`observed in patients treated with the JAK inhibitor compared with TNF blockers. Consider the benefits and risks for the
`individual patient prior to initiating or continuing therapy with OLUMIANT.
`
`5.3 Malignancy and Lymphoproliferative Disorders
`Malignancies were observed in clinical studies of OLUMIANT [see Adverse Reactions (6.1)].
`
`In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients, a higher rate of malignancies
`(excluding non-melanoma skin cancer (NMSC)) was observed in patients treated with the JAK inhibitor compared to those
`treated with TNF blockers. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared
`to those treated with TNF blockers. A higher rate of lung cancers was observed in current or past smokers treated with the
`JAK inhibitor compared to those treated with TNF blockers. In this study, current or past smokers had an additional
`increased risk of overall malignancies.
`
`Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OLUMIANT,
`particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a
`malignancy, and patients who are current or past smokers.
`
`Non-melanoma skin cancers
`Non-melanoma skin cancers (NMSCs) have been reported in patients treated with OLUMIANT. Periodic skin examination
`is recommended for patients who are at increased risk for skin cancer.
`
`5.4 Major Adverse Cardiovascular Events
`In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with
`at least one cardiovascular risk factor, a higher rate of major adverse cardiovascular events (MACE) defined as
`cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke was observed with the JAK inhibitor
`compared to those treated with TNF blockers. Patients who are current or past