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.

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 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:
o Patients who are on dialysis, have end-stage renal disease (ESRD, EGFR
<15 mL/min/1.73 m2), or have acute kidney injury
o 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.

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• 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 for Patients with Abnormal Laboratory Valuesa, b

Laboratory Laboratory Analyte
Recommendation
Analyte Value
• Adults and pediatric patients 9 years of age and
older: 4 mg once daily
≥60 mL/min/1.73 m2
• Pediatric patients 2 years to less than 9 years of
age: 2 mg once daily
• Adults and pediatric patients 9 years of age and
30 to <60 older: 2 mg once daily
eGFR mL/min/1.73 m2 • Pediatric patients 2 years to less than 9 years of
age: 1 mg once daily
• Adults and pediatric patients 9 years of age and
15 to <30 older: 1 mg once daily
mL/min/1.73 m2 • Pediatric patients 2 years to less than 9 years of
age: Not recommended
<15 mL/min/1.73 m2 Not recommended
Absolute ≥200 cells/µL Maintain dose
Lymphocyte Count
(ALC) <200 cells/µL Consider interruption until ALC is ≥200 cells/µL
Absolute ≥500 cells/µL Maintain dose
Neutrophil Count
(ANC) <500 cells/µL Consider interruption until ANC is ≥500 cells/µL
If increases in ALT
or AST are observed
Interrupt baricitinib until the diagnosis of DILI is
Aminotransferases and drug-induced
excluded
liver injury (DILI) is
suspected
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.

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.

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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.
o 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.
o 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 and/or 2-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 and/or 2-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).

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• Administration via nasogastric feeding tube:
For patients with an enteral feeding tube, 1-mg and/or 2-mg baricitinib tablet(s), or a
combination of tablets necessary to achieve the desired dose 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

Container Rinse
Administration via Dispersion Volume
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). In patients taking strong
OAT3 inhibitors, such as probenecid, reduce the recommended dose as follows:
• If the recommended dose is 4 mg once daily, reduce dose to 2 mg once daily.
• If the recommended dose is 2 mg once daily, reduce dose to 1 mg once daily.
• If the recommended dose is 1 mg once daily, consider discontinuing 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.

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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.

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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].

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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

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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

ACTT-2 AND COV-BARRIER
Patients with at least 1: PBO BARICITINIB 4-MG
(N = 1261) (N =1257)
n (%) n (%)
TEAE 576 (46) 544 (43)
SAE 244 (19) 197 (16)
Deathc 137 (11) 84 (7)
DCAE 145 (12) 104 (8)
Infections 183 (15) 159 (13)
Venous thrombotic eventsd 27 (2) 37 (3)
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.

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

Placebo Baricitinib
4 mg
n= 1261 n= 1257
n (%) 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 Paramentersa

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 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)
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.

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) 1 mg (NDC 0002-4732-30)
• OLUMIANT (baricitinib) 2 mg (NDC 0002-4182-30)

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.

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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:
a. Given the “Fact Sheet for Patients, Parents and Caregivers”,
b. Informed of alternatives to receiving authorized baricitinib, and
c. 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:
o Complete and submit the report online:
www.fda.gov/medwatch/report.htm, or
o 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
o Call 1-800-FDA-1088 to request a reporting form.
o 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;

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 • 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: [email protected]

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.

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.

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.

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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.

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 July 2021

Eli Lilly and Company, Indianapolis, IN 46285, USA

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