FDA Label for Baricitinib

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PACKAGE LABEL – BARICITINIB 4 MG 30CT BOTTLE

Baricitinib Product Label

The following document was submitted to the FDA by the labeler of this product Eli Lilly And Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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.

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.

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.

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 Values^{a, b}
Laboratory Analyte	Laboratory Analyte Value	Recommendation
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 mg^c once daily
	15 to <30 mL/min/1.73 m²	Adults and pediatric patients 9 years of age and older: 1 mg^c once daily Pediatric patients 2 years to less than 9 years of age: Not recommended
	<15 mL/min/1.73 m²	Not recommended
Absolute Lymphocyte Count (ALC)	≥200 cells/μL	Maintain dose
Absolute Lymphocyte Count (ALC)	<200 cells/μL	Consider interruption until ALC is ≥200 cells/μL
Absolute Neutrophil Count (ANC)	≥500 cells/μL	Maintain dose
Absolute Neutrophil Count (ANC)	<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 Medication		Recommendation
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 mg^c 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.

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 via	Dispersion Volume	Container Rinse Volume
Oral dispersion	10 mL	10 mL
Gastrostomy tube (G tube)	15 mL	15 mL
Nasogastric tube (NG tube)	30 mL	15 mL

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.

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.

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:

Not hospitalized, no limitations on activities [OS-1];
Not hospitalized, limitation on activities and/or requiring home oxygen [OS-2];
Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care [OS-3];
Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) [OS 4];
Hospitalized, requiring supplemental oxygen [OS 5];
Hospitalized, on non-invasive ventilation or high-flow oxygen devices [OS 6];
Hospitalized, on invasive mechanical ventilation or ECMO [OS 7]; and
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 Population^a,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)
Death^c	137 (11)	84 (7)
DCAE	145 (12)	104 (8)
Infections	183 (15)	159 (13)
Venous thrombotic events^d	27 (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 Parameters^a
Clinical Chemistry
Creatine Phosphokinase >5 x ULN ^b	20 (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/mm³	22 (1.9)	26 (2.2)
Thrombocytosis >600,000 cells/mm³	30 (4.3)	57 (8.2)

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.

Important Information for Patients, Parents and Caregivers

See Fact Sheets for Patients, Parents and Caregivers.

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):

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.
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:
- Given the “Fact Sheet for Patients, Parents and Caregivers”,
- Informed of alternatives to receiving authorized baricitinib, and
- Informed that baricitinib is an approved drug that is authorized for the unapproved use under this Emergency Use Authorization.
- Patients must have an eGFR, aminotransferases, and CBC with differential determined prior to first administration of baricitinib.
- 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).”

Package Label – Baricitinib 4 Mg 30Ct Bottle

Rx Only

Always Dispense With Medication Guide

NDC 0002-6885-30

baricitinib

tablets

4 mg

For use under Emergency Use Authorization (EUA).

30 tablets

Lilly

* Please review the disclaimer below.

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Baricitinib Product Label

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Package Label – Baricitinib 4 Mg 30Ct Bottle