Label: BARICITINIB tablet, film coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 23, 2022

If you are a consumer or patient please visit this version.

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    FACT SHEET FOR HEALTHCARE PROVIDERS
    EMERGENCY USE AUTHORIZATION (EUA) OF BARICITINIB

    The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of baricitinib for treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

    Baricitinib has been authorized by FDA for the emergency uses described above. Baricitinib is not FDA-approved for these uses.

    Baricitinib is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of baricitinib under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.

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    This EUA is for the unapproved use of baricitinib to treat COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.

    Baricitinib is administered orally.

    To request baricitinib under Emergency Use Authorization (EUA): In-patient pharmacies may order directly from an Authorized Distributor of Record. A current list of Lilly's Authorized Distributors of Record is available at www.lillytrade.com or visit www.baricitinibemergencyuse.com for additional access information.

    Healthcare providers must submit a report on all medication errors and ALL SERIOUS ADVERSE EVENTS potentially related to baricitinib.

    See specific reporting instructions below.

    The recommended dosage of baricitinib under the EUA is:

    • Adults and pediatric patients 9 years of age and older: 4 mg once daily
    • Pediatric patients 2 years to less than 9 years of age: 2 mg once daily

    Dosage adjustments are recommended for laboratory abnormalities, including renal impairment (see Table 1).

    The optimal duration of treatment is unknown.

    The recommended total treatment duration of baricitinib is 14 days or until hospital discharge, whichever comes first.

    For information on clinical trials that are testing the use of baricitinib in COVID-19, please see www.clinicaltrials.gov.

    This Fact Sheet may be updated as new data become available. The most recent version of this Fact Sheet is available at www.baricitinibemergencyuse.com for download.

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    INSTRUCTIONS FOR ADMINISTRATION

    This section provides essential information on the unapproved use of baricitinib to treat COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO under this EUA.

    For more information, including pharmacokinetics and safety information of baricitinib, tradename Olumiant®, see the FDA-approved package insert at http://pi.lilly.com/us/olumiant-uspi.pdf.

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    Contraindications

    There are no known contraindications for baricitinib.

    Dosing

    Patient Selection

    • Evaluate baseline eGFR, liver enzymes, and complete blood count to determine treatment suitability and dose. Monitor closely patients with abnormal baseline and post-baseline laboratory values. See Table 1 for dosage adjustments for patients with laboratory abnormalities.
    • Baricitinib is not recommended for:
      • Patients who are on dialysis, have end-stage renal disease (ESRD, EGFR <15 mL/min/1.73 m2), or have acute kidney injury
      • Patients with known active tuberculosis

    Adult Patients

    • The recommended dosage in adults with eGFR ≥60 mL/min/1.73 m2 is 4 mg once daily for 14 days of total treatment or until hospital discharge, whichever is first. See Table 1 for dosage adjustments for patients with laboratory abnormalities.
    • Dosage adjustments in patients with renal or hepatic impairment are recommended (see Renal Impairment, Hepatic Impairment).
    • Dosage adjustments due to drug interactions are recommended (see Drug Interactions).
    • In hospitalized patients with COVID-19, prophylaxis for venous thromboembolism (VTE) is recommended unless contraindicated (see Warnings).

    Pediatric Patients

    Limited data informing baricitinib dosing in pediatric patients comes from ongoing clinical trials for other uses. Based on the available information, treatment for COVID-19 for pediatric patients under this EUA is as follows:

    • The recommended dosage for patients 9 years of age and older is 4 mg once daily for 14 days of total treatment or until hospital discharge, whichever is first.
    • The recommended dosage for patients ages 2 years through less than 9 years of age is 2 mg once daily for 14 days of total treatment or until hospital discharge, whichever is first.
    • Baricitinib is not authorized for patients younger than 2 years of age.
    • Dosage adjustments in patients with renal or hepatic impairment are recommended (see Renal Impairment, Hepatic Impairment).
    Table 1: Dosage Adjustments

    a Abbreviations: ALC = absolute lymphocyte count, ALT = alanine transaminase, ANC = absolute neutrophil count, AST = aspartate transaminase, DILI = drug induced liver injury, eGFR = estimated glomerular filtration rate.

    b If a laboratory abnormality is likely due to the underlying disease state, consider the risks and benefits of continuing baricitinib at the same or a reduced dose.

    c Only if a 1 mg tablet is not available, a 2 mg tablet can be split using a tablet splitter that has a razor blade to administer half a 2 mg tablet once daily. The tablet should be split along the longest diameter. If the portions of the tablet are determined to be visually unequal they should be discarded. Take care in storing the second tablet half to avoid breakage prior to next dose.

    Dosage Adjustments for Patients with Abnormal Laboratory Valuesa, b
    Laboratory AnalyteLaboratory Analyte ValueRecommendation
    eGFR ≥60 mL/min/1.73 m2
    • Adults and pediatric patients 9 years of age and older: 4 mg once daily
    • Pediatric patients 2 years to less than 9 years of age: 2 mg once daily
    30 to <60 mL/min/1.73 m2
    • Adults and pediatric patients 9 years of age and older: 2 mg once daily
    • Pediatric patients 2 years to less than 9 years of age: 1 mgc once daily
    15 to <30 mL/min/1.73 m2
    • Adults and pediatric patients 9 years of age and older: 1 mgc once daily
    • Pediatric patients 2 years to less than 9 years of age: Not recommended
    <15 mL/min/1.73 m2Not recommended
    Absolute Lymphocyte Count (ALC) ≥200 cells/μL Maintain dose
    <200 cells/μL Consider interruption until ALC is ≥200 cells/μL
    Absolute Neutrophil Count (ANC) ≥500 cells/μL Maintain dose
    <500 cells/μL Consider interruption until ANC is ≥500 cells/μL
    Aminotransferases If increases in ALT or AST are observed and drug-induced liver injury (DILI) is suspected Interrupt baricitinib until the diagnosis of DILI is excluded
    Dosage Adjustments when Coadministered with Other Medications
    Concomitant MedicationRecommendation
    Strong OAT3 Inhibitors (e.g., probenecid)
    • If the recommended baricitinib dose is 4 mg once daily, reduce dose to 2 mg once daily.
    • If the recommended baricitinib dose is 2 mg once daily, reduce dose to 1 mgc once daily.
    • If the recommended baricitinib dose is 1 mg once daily, consider discontinuing probenecid.

    Pregnancy

    Baricitinib should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus. Consistent with the mechanism of action, embryo-fetal toxicities including skeletal anomalies and reduced fertility have been observed in animals dosed in excess of the maximum human exposure. The limited human data on use of baricitinib in pregnant women are not sufficient to inform a drug-associated risk for major birth defects or miscarriage.

    See also Section 8.1 Pregnancy in the FDA approved full prescribing information for more information.

    Renal Impairment

    There are limited data for baricitinib in patients with severe renal impairment.

    • Baricitinib is not recommended for patients who are on dialysis, have ESRD, or have acute kidney injury.
    • See Table 1 for treatment modifications for patients with laboratory abnormalities.
      • Baricitinib should only be used in adults and pediatric patients 9 years of age and older with eGFR 15 to <30 mL/min/1.73 m2 if the potential benefit outweighs the potential risk.
      • Baricitinib is not recommended for pediatric patients ages 2 years through less than 9 years of age with eGFR <30 mL/min/1.73 m2.

    Hepatic Impairment

    Baricitinib has not been studied in patients with severe hepatic impairment. Baricitinib should only be used in patients with severe hepatic impairment if the potential benefit outweighs the potential risk. It is not known if dosage adjustment is needed in patients with severe hepatic impairment.

    See Table 1 for dosage adjustments for patients with abnormal laboratory values.

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    Administration

    Baricitinib tablets are given orally once daily with or without food.

    Alternate Administration

    For patients who are unable to swallow whole tablets, alternate administration may be considered:

    • Oral dispersion
    • Gastrostomy tube (G tube)
    • Nasogastric tube (NG tube)

    Preparation for Alternate 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 (see Table 2).
    • Administration via gastrostomy feeding tube:
      For patients with a gastrostomy feeding 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 (see Table 2).
    • Administration via nasogastric feeding tube:
      For patients with an enteral feeding 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 (see Table 2).

    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. 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.

    Table 2: Dispersion and Rinse Volume for Alternate Administration
    Administration viaDispersion VolumeContainer Rinse Volume
    Oral dispersion 10 mL 10 mL
    Gastrostomy tube (G tube) 15 mL 15 mL
    Nasogastric tube (NG tube) 30 mL 15 mL
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    Drug Interactions

    Strong OAT3 Inhibitors: Baricitinib exposure is increased when baricitinib is co-administered with strong OAT3 inhibitors (such as probenecid). See Table 1 for dosage adjustments for patients taking strong OAT3 inhibitors, such as probenecid.

    Other JAK Inhibitors or biologic disease modifying anti-rheumatic drugs (DMARDs): Baricitinib has not been studied in combination with other JAK inhibitors or with biologic DMARDs (biologic treatments targeting cytokines, B-cells, or T-cells) and is not recommended.

    Pharmacology

    Pharmacokinetics: The pharmacokinetics in patients with COVID-19 who are intubated and have baricitinib administered via NG tube is similar to that in healthy subjects. The half-life of baricitinib in healthy subjects is approximately 10 hours.

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    Warnings

    Serious Infections

    There is limited information regarding use of baricitinib in patients with COVID-19 and concomitant active serious infections.

    Serious infections have occurred in patients receiving baricitinib:

    • Avoid the use of baricitinib with known active tuberculosis.
    • Consider if the potential benefits outweigh the potential risks of baricitinib treatment in patients with active serious infections other than COVID-19 or chronic / recurrent infections.

    Thrombosis

    In hospitalized patients with COVID-19, prophylaxis for VTE is recommended unless contraindicated. If clinical features of deep vein thrombosis/pulmonary embolism occur, patients should be evaluated promptly and treated appropriately.

    Abnormal Laboratory Values

    There is limited information regarding use of baricitinib in patients with COVID-19 and any of the following clinical findings:

    • ANC <1000 cells/mm3
    • ALC <200 cells/mm3
    • Hemoglobin <8 g/dL

    Evaluate at baseline and thereafter according to local patient management practice. Monitor closely when treating patients with abnormal baseline and post-baseline laboratory values.

    See Table 1 for dosage adjustments for patients with abnormal renal, hematological and hepatic laboratory values. Manage patients according to routine clinical guidelines.

    Vaccinations

    Avoid use of live vaccines with baricitinib.

    Hypersensitivity

    If a serious hypersensitivity occurs, discontinue baricitinib while evaluating the potential causes of the reaction.

    See Warnings and Precautions in the FDA approved full prescribing information for additional information on risks associated with longer-term treatment with baricitinib.

    Serious Side Effects

    Serious venous thrombosis, including pulmonary embolism, and serious infections have been observed in COVID-19 patients treated with baricitinib and are known adverse drug reactions of baricitinib.

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    Scientific Evidence Supporting This EUA

    The efficacy and safety of baricitinib were assessed in 2 Phase 3, randomized, double-blind, placebo-controlled clinical trials:

    • ACTT-2, which evaluated the combination of baricitinib 4 mg + remdesivir compared to placebo + remdesivir.
    • COV-BARRIER, which evaluated baricitinib 4 mg compared to placebo. Patients could remain on background therapy, as defined per local guidelines.

    Efficacy

    ACTT-2 (Adaptive COVID-19 Treatment Trial 2) Study in Hospitalized Adults Diagnosed with COVID-19 Infection

    A randomized, double-blind, placebo-controlled clinical trial (ACTT-2, NCT04401579) of hospitalized adults with confirmed SARS-CoV-2 infection compared treatment with baricitinib, a JAK inhibitor, plus remdesivir, an anti-viral (combination group; n=515) with placebo plus remdesivir (placebo group; n=518). Patients had to have laboratory-confirmed SARS-CoV-2 infection as well as at least one of the following to be enrolled in the trial: radiographic infiltrates by imaging, SpO2≤94% on room air, a requirement for supplemental oxygen, or a requirement for mechanical ventilation or ECMO. Patients treated with the combination received the following regimen:

    • Baricitinib 4 mg once daily (orally) for 14 days or until hospital discharge
    • Remdesivir 200 mg on Day 1 and 100 mg once daily (via intravenous infusion) on subsequent days for a total treatment duration of 10 days or until hospital discharge

    For the overall population (N=1033 patients) at randomization, mean age was 55 years (with 30% of patients aged 65 or older); 63% of patients were male, 51% were Hispanic or Latino, 48% were White, 15% were Black or African American, and 10% were Asian; 14% did not require supplemental oxygen, 55% required supplemental oxygen, 21% required non-invasive ventilation or high-flow oxygen, and 11% required invasive mechanical ventilation or ECMO. The most common comorbidities were obesity (56%), hypertension (52%), and type 2 diabetes (37%). Demographics and disease characteristics were balanced across the combination group and the placebo group.

    The primary endpoint, for the intent to treat population, was time to recovery within 29 days after randomization. Recovery was defined as being discharged from the hospital without limitations on activities, being discharged from the hospital with limitations on activities and/or requiring home oxygen or hospitalized but not requiring supplemental oxygen and no longer requiring medical care. The key secondary endpoint was clinical status on Day 15 assessed on an 8-point ordinal scale (OS) consisting of the following categories:

    1. Not hospitalized, no limitations on activities [OS-1];
    2. Not hospitalized, limitation on activities and/or requiring home oxygen [OS-2];
    3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care [OS-3];
    4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) [OS 4];
    5. Hospitalized, requiring supplemental oxygen [OS 5];
    6. Hospitalized, on non-invasive ventilation or high-flow oxygen devices [OS 6];
    7. Hospitalized, on invasive mechanical ventilation or ECMO [OS 7]; and
    8. Death [OS 8]

    For the overall population, the median time to recovery (defined as discharged from hospital or hospitalized but not requiring supplemental oxygen or ongoing medical care) was 7 days for baricitinib + remdesivir compared to 8 days for placebo + remdesivir [hazard ratio: 1.15 (95% CI 1.00, 1.31); p=0.047].

    Patients assigned to baricitinib + remdesivir were more likely to have a better clinical status (according to an 8-point ordinal scale) at Day 15 compared to patients assigned to placebo + remdesivir [odds ratio: 1.26 (95% CI 1.01, 1.57); p=0.044].

    The proportion of patients who died or progressed to non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation by Day 29 was lower in baricitinib + remdesivir (23%) compared to placebo + remdesivir (28%) [odds ratio: 0.74 (95% CI 0.56, 0.99); p=0.039]. Patients who required non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO) at baseline needed to worsen by at least 1 point on an 8-point ordinal scale to progress.

    The proportion of patients who died by Day 29 was 4.7% (24/515) for baricitinib + remdesivir vs. 7.1% (37/518) for placebo + remdesivir [Kaplan Meier estimated difference in Day 29 probability of mortality: -2.6% (95% CI -5.8%, 0.5%)].

    COV-BARRIER Study in Hospitalized Adults Diagnosed with COVID-19 Infection

    A randomized, double-blind, placebo-controlled clinical trial (COV-BARRIER, NCT04421027) of hospitalized adults with confirmed SARS-CoV-2 infection compared treatment with baricitinib 4mg once daily (n=764) with placebo (n=761). Patients could remain on background standard of care, as defined per local guidelines, including antimalarials, antivirals, corticosteroids, and/or azithromycin. The most frequently used therapies were:

    • corticosteroids (79% of patients, mostly dexamethasone)
    • remdesivir (19% of patients)

    Patients had to have laboratory-confirmed SARS-CoV-2 infection, at least one instance of elevation in at least one inflammatory marker (CRP, D-dimer, LDH, ferritin), and at least one of the following to be enrolled in the trial: radiographic infiltrates by imaging, SpO2≤94% on room air, evidence of active COVID infection (with clinical symptoms including any of the following: fever, vomiting, diarrhea, dry cough, tachypnea defined as respiratory rate >24 breaths/min) or requirement for supplemental oxygen. Patients requiring invasive mechanical ventilation or ECMO at baseline were enrolled in a sub-study of COV-BARRIER that is ongoing.

    For the overall population (N=1525 patients) at randomization, mean age was 58 years (with 33% of patients aged 65 or older); 63% of patients were male, 62% were White, 5% were Black or African American,12% were Asian; 12% did not require supplemental oxygen (OS 4), 63% required supplemental oxygen (OS 5), 24% required non-invasive ventilation or high-flow oxygen (OS 6). The most common comorbidities were hypertension (48%), obesity (33%), and type 2 diabetes (29%). Demographics and disease characteristics were balanced across the baricitinib and placebo groups.

    The primary endpoint was the proportion of patients who died or progressed to non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation within the first 28-days of the study. Patients who required non-invasive ventilation/high-flow oxygen at baseline needed to worsen by at least 1 point on an 8-point ordinal scale to progress. A key secondary endpoint was all-cause mortality by Day 28.

    The estimated proportion of patients who died or progressed to non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation was lower in patients treated with baricitinib (27.8%) compared to placebo (30.5%), but this effect was not statistically significant [odds ratio: 0.85 (95% CI 0.67, 1.08); p=0.180].

    The proportion of patients who died by Day 28 was 8.1% (62/764) for baricitinib vs. 13.3% (101/761) for placebo [estimated difference in Day 28 probability of mortality = -4.9% (95% CI: -8.0%, -1.9%); hazard ratio = 0.56 (95% CI: 0.41, 0.77)].

    Safety

    In placebo-controlled COVID-19 clinical trials, ACTT-2 and COV-BARRIER, for up to 29 days, 1257 patients received at least one dose of baricitinib 4 mg once daily, and 1261 patients received placebo, for up to 14 days or hospital discharge, whichever occurred first. Data on deaths, serious adverse events (SAEs), AEs leading to discontinuation, and infections are summarized in Table 3.

    Table 3: Comparisons of Adverse Events in the Safety Populationa,b

    a Abbreviations: TEAE = treatment emergent adverse event; AE=adverse event; DCAE= AE leading to discontinuation of study drug (including death due to AE); N = number of patients in the Safety Population; n = number of patients reporting at least 1 event; SAE = serious adverse event;

    b Patients are counted once for each category regardless of the number of events.

    c Includes patients who died from any cause

    d Includes positively adjudicated pulmonary embolism and deep vein thrombosis.

    ACTT-2 AND COV-BARRIER

    Patients with at least 1:PBO
    (N = 1261)
    n (%)
    BARICITINIB 4-MG
    (N = 1257)
    n (%)
    TEAE 576 (46) 544 (43)
    SAE 244 (19) 197 (16)
    Deathc137 (11) 84 (7)
    DCAE 145 (12) 104 (8)
    Infections 183 (15) 159 (13)
    Venous thrombotic eventsd27 (2) 37 (3)

    Of the known adverse drug reactions of baricitinib in clinical trials of other indications, Table 4 summarizes the observed frequencies of adverse reactions occurring in ≥ 1% of patients during the first 29 days of studies ACTT-2 and COV-BARRIER.

    Table 4: Adverse Reactions Occurring in ≥1% in the Safety Population

    a As assessed by measured values within the clinical trial database. Frequencies are based on shifts from pre-treatment to post-treatment (with number at risk as the denominator), except for ALT and AST for which frequencies are based on observed elevation during treatment.

    b Creatine phosphokinase frequencies presented in the table were available for a single trial in patients with COVID-19 (KHAA) and do not represent integrated data.

    Placebo
    (n = 1261)
    n (%)
    Baricitinib
    4 mg
    (n = 1257)
    n (%)
    Infections and infestations
    Urinary tract infection 10 (0.8) 16 (1.3)
    Respiratory, thoracic, mediastinal disorders
    Pulmonary embolism 11 (0.9) 18 (1.4)
    Vascular Disorders
    Deep Vein Thrombosis 16 (1.3) 19 (1.5)
    Laboratory Parametersa
    Clinical Chemistry
    Creatine Phosphokinase >5 x ULN b20 (3.3) 22 (3.7)
    ALT ≥3 x ULN 189 (15.6) 219 (18.0)
    AST ≥3 x ULN 110 (9.1) 140 (11.5)
    Hematology
    Neutropenia <1000 cells/mm322 (1.9) 26 (2.2)
    Thrombocytosis >600,000 cells/mm330 (4.3) 57 (8.2)
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    How Supplied/Storage and Handling

    How Supplied

    Baricitinib for oral administration is available as debossed, film-coated, immediate-release tablets. Each tablet contains a recessed area on each face of the tablet surface.

    Under this EUA, baricitinib is supplied in 30 count bottles as follows:

    • OLUMIANT (baricitinib) tablet 1 mg (NDC 0002-4732-30)
    • OLUMIANT (baricitinib) tablet 2 mg (NDC 0002-4182-30), and
    • baricitinib tablet 4 mg (NDC 0002-6885-30)

    Storage and Handling

    Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).

    Keep out of reach of children.

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    Important Information for Patients, Parents and Caregivers

    See Fact Sheets for Patients, Parents and Caregivers.

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    INSTRUCTIONS FOR HEALTHCARE PROVIDERS

    As the healthcare provider, you must communicate to your patient or parent/caregiver, as age appropriate, information consistent with the “Fact Sheet for Patients, Parents and Caregivers” (and provide a copy of the Fact Sheet) prior to the patient receiving baricitinib, including:

    • FDA has authorized the emergency use of baricitinib to treat COVID-19 in hospitalized adults and pediatric patients 2 years or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). This is not an FDA-approved use of baricitinib.
    • The patient or parent/caregiver has the option to accept or refuse baricitinib.
    • The significant known and potential risks and benefits of baricitinib, and the extent to which such potential risks and benefits are unknown.
    • Information on available alternative treatments and the risks and benefits of those alternatives, including clinical trials.

    If providing this information will delay the administration of baricitinib to a degree that would endanger the lives of patients, the information must be provided to the patients as soon as practicable after baricitinib is administered.

    For information on clinical trials that are testing the use of baricitinib for COVID-19, please see www.clinicaltrials.gov.

    MANDATORY REQUIREMENTS FOR BARICITINIB ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION

    In order to mitigate the risks of using this approved product for an unapproved use under EUA and to optimize the potential benefit of baricitinib, the following items are required. Use of baricitinib under this EUA is limited to the following (all requirements must be met):

    1. Treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.
    2. As the healthcare provider, communicate to your patient or parent/caregiver information consistent with the “Fact Sheet for Patients, Parents and Caregivers” prior to the patient receiving baricitinib. Healthcare providers (to the extent practicable given the circumstances of the emergency) must document in the patient's medical record that the patient/caregiver has been:
      1. Given the “Fact Sheet for Patients, Parents and Caregivers”,
      2. Informed of alternatives to receiving authorized baricitinib, and
      3. Informed that baricitinib is an approved drug that is authorized for the unapproved use under this Emergency Use Authorization.
    3. Patients must have an eGFR, aminotransferases, and CBC with differential determined prior to first administration of baricitinib.
    4. The prescribing healthcare provider and/or the provider's designee are/is responsible for mandatory reporting of all medication errors and all serious adverse events* potentially related to baricitinib treatment within 7 calendar days from the onset of the event. The reports should include unique identifiers and the words “Baricitinib treatment under Emergency Use Authorization (EUA)” in the description section of the report.
      • Submit adverse event reports to FDA MedWatch using one of the following methods:
        • Complete and submit the report online:
          www.fda.gov/medwatch/report.htm, or
        • Complete and submit a postage-paid Form FDA 3500
          (https://www.fda.gov/media/76299/download) and return by:
          • Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or
          • Fax (1-800-FDA-0178), or
        • Call 1-800-FDA-1088 to request a reporting form.
        • Submitted reports should include in the field name, “Describe Event, Problem, or Product Use/Medication Error” the statement “Baricitinib use for COVID-19 under Emergency Use Authorization (EUA).”

      *Serious Adverse Events are defined as:

      • death;
      • a life-threatening adverse event;
      • inpatient hospitalization or prolongation of existing hospitalization;
      • a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
      • a congenital anomaly/birth defect;
      • a medical or surgical intervention to prevent death, a life-threatening event, hospitalization, disability, or congenital anomaly.
    5. The prescribing healthcare provider and/or the provider's designee are/is to provide mandatory responses to requests from FDA for information about adverse events and medication errors following receipt of baricitinib.
    6. OTHER REPORTING REQUIREMENTS
      Report adverse events or medication errors to Lilly at:
      1-855-LillyC19 (1-855-545-5921)

    In addition, please provide a copy of all FDA MedWatch forms to:

    Eli Lilly and Company, Global Patient Safety

    Fax: 1-317-277-0853

    E-mail: mailindata_gsmtindy@lilly.com

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    APPROVED AVAILABLE ALTERNATIVES

    There is no adequate, approved and available alternative to baricitinib for treatment of COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Additional information on COVID-19 treatments can be found at https://www.cdc.gov/coronavirus/2019-ncov/index.html. The healthcare provider should visit https://clinicaltrials.gov/ to determine whether the patient may be eligible for enrollment in a clinical trial.

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    AUTHORITY FOR ISSUANCE OF THE EUA

    The Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency that justifies the emergency use of baricitinib to treat COVID-19 caused by SARS-CoV-2. In response, the Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the unapproved use of baricitinib for the treatment of COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.1 As a healthcare provider, you must comply with the mandatory requirements of the EUA (see “MANDATORY REQUIREMENTS FOR BARICITINIB ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION” above).

    FDA issued this EUA, requested by Eli Lilly and Company based on the submitted data.

    Although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that baricitinib may be effective for treatment of COVID-19 in certain patients as specified in this Fact Sheet. You may be contacted and asked to provide information to help with the assessment of the use of the product during this emergency.

    This EUA for baricitinib will end when the Secretary determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.


    1
    The health care provider should visit clinicaltrials.gov to determine whether there is an active clinical trial for the product in this disease/condition and whether enrollment of the patient(s) in a clinical trial is more appropriate than product use under this EUA.
  • SPL UNCLASSIFIED SECTION

    CONTACT INFORMATION

    If you have questions, please contact:

    1-855-LillyC19 (1-855-545-5921)

    For additional information visit:

    www.baricitinibemergencyuse.com

    END FACT SHEET

    Revised December 2021

    Eli Lilly and Company, Indianapolis, IN 46285, USA

    Copyright © 2020, 2021, Eli Lilly and Company. All rights reserved.

    BAR-0004-EUA HCP-20211220

  • SPL UNCLASSIFIED SECTION

    Fact Sheet for Patients, Parents and Caregivers
    Emergency Use Authorization (EUA) of Baricitinib

    You (or your child) are being given a medicine called baricitinib to treat coronavirus disease 2019 (COVID-19). This Fact Sheet contains information to help you understand the risks and benefits of taking baricitinib, which you have received or may receive.

    Taking baricitinib may benefit certain people in the hospital with COVID-19. This Fact Sheet provides you with the significant known and potential risks and benefits of the emergency use of baricitinib for treatment of COVID-19. Healthcare providers can recommend or provide baricitinib to people they believe may benefit from it as authorized.

    Read this Fact Sheet for information about baricitinib and talk to your healthcare provider if you have questions. It is your choice to take baricitinib or stop it at any time.

    What is COVID-19?

    COVID-19 is caused by a virus called a coronavirus. You can get COVID-19 through contact with another person who has the virus. COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. While information so far suggests that most COVID-19 illness is mild, serious illness can happen and may cause some of your other medical conditions to become worse. Older people and people of all ages with severe, long-lasting (chronic) medical conditions like heart disease, lung disease, and diabetes, for example, seem to be at higher risk of being hospitalized for COVID-19.

    What are the symptoms of COVID-19?

    The symptoms of COVID-19 include fever, cough, and shortness of breath, which may appear 2 to 14 days after exposure. Serious illness including breathing problems can occur and may cause your other medical conditions to become worse.

    What is baricitinib?

    Baricitinib is a prescription medicine that is FDA approved to treat adult patients with moderately to severely active rheumatoid arthritis after treatment with at least one other medicine called a Tumor Necrosis Factor (TNF) antagonist has been used and did not work well enough or could not be tolerated. Baricitinib is not FDA-approved to treat COVID-19.

    Baricitinib is being studied for the treatment of certain people in the hospital with COVID-19. There is limited information about the safety and effectiveness of using baricitinib to treat people in the hospital with COVID-19.

    The FDA has authorized the emergency use of baricitinib for the treatment of COVID-19 under an Emergency Use Authorization (EUA). For more information on EUA, see the section “What is an Emergency Use Authorization (EUA)?” at the end of this Fact Sheet.

    What should I tell my healthcare provider before taking baricitinib?

    Tell your healthcare provider about all of your medical conditions, including if you:

    • Have an infection other than COVID-19. You should not take baricitinib if you have an active tuberculosis infection.
    • Have hepatitis B, hepatitis C, or HIV.
    • Have ever had any type of cancer.
    • Have had blood clots.
    • Have kidney problems. You should not take baricitinib if you have sudden, severe kidney problems or you are on dialysis.
    • Have liver problems.
    • Have low red or white blood cell counts.
    • Have recently received a vaccine.
    • Are pregnant or breastfeeding.
    • Are allergic to baricitinib.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    Especially tell your healthcare provider if you take:

    • Probenecid
    • Any medicines that affect your immune system

    How should I take baricitinib?

    Baricitinib is given to you by mouth 1 time each day for 14 days or until you are discharged from the hospital (whichever comes first), as instructed by your healthcare provider.

    What are the important possible side effects of baricitinib?

    Baricitinib may cause serious side effects, including:

    • Serious infections. Baricitinib is a medicine that affects your immune system. Baricitinib can lower the ability of your immune system to fight infections other than COVID-19.
    • Blood clots. Blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) can happen in some people taking baricitinib. This may be life threatening and cause death.
    • Changes in certain laboratory test results. Your healthcare provider should do blood tests before you start taking baricitinib to check how well your kidney and liver are working, as well as low white blood cells that help the body fight infections.
    • Allergic reactions. Tell your healthcare provider right away if you have symptoms such as rash, swelling of your lips, tongue, or throat, or hives (raised red patches of skin that are often very itchy). This may mean you are having an allergic reaction.

    For more information see the Medication Guide for Olumiant® (baricitinib), at http://pi.lilly.com/us/olumiant-us-mg.pdf.

    Tell your healthcare provider immediately if you get:

    • swelling, pain or tenderness in the leg
    • sudden unexplained chest pain
    • sudden worsening shortness of breath
    • rash, swelling of your lips, tongue, or throat, or hives

    What other treatment choices are there?

    A medicine to treat people in the hospital with COVID-19 has been FDA approved. Like baricitinib, FDA may allow for the emergency use of other medicines that are not approved by FDA to treat people in the hospital with COVID-19. Go to https://www.covid19treatmentguidelines.nih.gov/ for information on the emergency use of other medicines that are not approved by FDA to treat people in the hospital with COVID-19. Your healthcare provider may talk with you about clinical trials you may be eligible for.

    It is your choice to be treated or not to be treated with baricitinib. Should you decide not to receive it or stop it at any time, it will not change your standard medical care.

    What if I am pregnant or breastfeeding?

    Baricitinib has not been studied in pregnant women or breastfeeding mothers. It is not known if baricitinib will harm your unborn baby or if baricitinib passes into your breast milk. If you are pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider.

    How do I report side effects with baricitinib?

    Tell your healthcare provider if you have any side effect that bothers you or does not go away. Report side effects to FDA MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Lilly by calling 1-855-LillyC19 (1-855-545-5921).

    How can I learn more?

    • Ask your healthcare provider
    • Visit https://www.cdc.gov/coronavirus/2019-ncov/index.html
    • Contact your local or state public health department

    What is an Emergency Use Authorization (EUA)?

    The United States FDA has made baricitinib available under an emergency access mechanism called an EUA as a treatment for certain patients with COVID-19. The EUA is supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.

    Baricitinib, as a treatment for COVID-19, has not undergone the same type of review as an FDA-approved or cleared product. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that it is reasonable to believe that the product meets certain criteria for safety, performance, and labeling and may be effective in treatment of patients during the COVID-19 pandemic. All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic.

    The EUA for baricitinib as a treatment for certain patients with COVID-19 is in effect for the duration of the COVID-19 declaration justifying emergency use of these products, unless terminated or revoked (after which the products may no longer be used).

    Revised July 2021

    Eli Lilly and Company, Indianapolis, IN 46285, USA

    Copyright © 2020, 2021, Eli Lilly and Company. All rights reserved.

    BAR-0002-EUA PAT-20210728

  • PACKAGE LABEL – BARICITINIB 4 mg 30ct Bottle

    Rx Only

    NDC 0002-6885-30

    baricitinib

    tablets

    4 mg

    For use under Emergency Use Authorization (EUA).

    30 tablets

    Lilly

    PACKAGE LABEL – OLUMIANT 4 mg 30ct Bottle
  • INGREDIENTS AND APPEARANCE
    BARICITINIB 
    baricitinib tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0002-6885
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    baricitinib (UNII: ISP4442I3Y) (baricitinib - UNII:ISP4442I3Y) baricitinib4 mg
    Inactive Ingredients
    Ingredient NameStrength
    Mannitol (UNII: 3OWL53L36A) 50 mg
    Cellulose, Microcrystalline (UNII: OP1R32D61U) 132 mg
    Croscarmellose Sodium (UNII: M28OL1HH48) 12 mg
    Magnesium Stearate (UNII: 70097M6I30) 2 mg
    Product Characteristics
    Colorpink (medium pink) Scoreno score
    ShapeROUND (round) Size9mm
    FlavorImprint Code Lilly;4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0002-6885-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Emergency Use Authorization12/20/2021
    Labeler - Eli Lilly and Company (006421325)