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Frequently Asked Questions (FAQs)

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

Baricitinib has not been approved for the treatment of COVID-19, but has been authorized for emergency use by the FDA.

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

Evaluate baseline eGFR, liver enzymes, and complete blood count to determine treatment suitability and dose and thereafter according to local patient management practice. Monitor closely when treating patients with abnormal baseline and post-baseline laboratory values.

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

Table 1: Dosage Adjustments for Patients with Abnormal Laboratory Valuesa,b

Laboratory Analyte Laboratory Analyte Value Recommendation
Estimated Glomerular Filtration Rate (eGFR) Laboratory Analyte Value:
 ≥60 mL/min/1.73 m2		 Recommendation:
  • Adults and pediatric patients ≥9 years of age: No dose adjustment
  • Pediatric patients 2 years to less than 9 years of age: 2 mg once daily
Estimated Glomerular Filtration Rate (eGFR) Laboratory Analyte Value:
 30 - <60 mL/min/1.73 m2		 Recommendation:
  • Adults and pediatric patients ≥9 years of age: 2 mg once daily
  • Pediatric patients 2 years to less than 9 years of age: 1 mg once daily
Estimated Glomerular Filtration Rate (eGFR) Laboratory Analyte Value:
 15 - <30 mL/min/1.73 m2		 Recommendation:
  • Adults and pediatric patients ≥9 years of age: 1 mg once daily
  • Pediatric patients 2 years to less than 9 years of age: Not recommended
Estimated Glomerular Filtration Rate (eGFR) Laboratory Analyte Value:
 <15 mL/min/1.73 m2		 Recommendation:
 Not recommended
Absolute Lymphocyte Count (ALC) Laboratory Analyte Value:
 ≥200 cells/µL 		Recommendation:
 Maintain dose
Absolute Lymphocyte Count (ALC) Laboratory Analyte Value:
 <200 cells/µL 		Recommendation:
 Consider interruption until ALC is ≥200 cells/µL
Absolute Neutrophil Count (ANC) Laboratory Analyte Value:
 ≥500 cells/µL 		Recommendation:
 Maintain dose
Absolute Neutrophil Count (ANC) Laboratory Analyte Value:
 <500 cells/µL 		Recommendation:
 Consider interruption until ANC is ≥500 cells/µL
Aminotransferases Laboratory Analyte Value:
 If increases in ALT or AST are observed and drug-induced liver injury (DILI) is suspected 		Recommendation:
 Interrupt baricitinib until the diagnosis of DILI is excluded

aAbbreviations: ALT=alanine transaminase; AST=aspartate transaminase; DILI=drug induced liver injury.

bIf 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.

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.
The FDA clarified that individuals determined as being appropriate for acute inpatient hospitalization and who are admitted or transferred to an alternate care site (ACS) that is capable of providing acute care that is comparable to general inpatient hospital care are within the terms and conditions of the Letter of Authorization. An ACS is intended to have additional hospital surge capacity and capabilities for communities overwhelmed by patients with COVID-19.
No, baricitinib is distributed via Lilly's Authorized Distributors of Record for the EUA to inpatient pharmacies. Lilly remains confident in being able to meet the supply needs of patients under the EUA, as well as for the existing approved indication.
For information related to participation in Lilly’s clinical trials, please call 1-877-285-4559 or email covid19potentialsite@lilly.com.
Patients should visit Lilly Trial Guide for information regarding eligibility for ongoing trials.
For information related to COVID-19, please visit: Centers for Disease Control and Prevention.

AUTHORIZED USE

Baricitinib is authorized for use under an Emergency Use Authorization (EUA) in combination with remdesivir, for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalized adults and pediatric patients 2 years of age or older, requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

  • Baricitinib has not been approved for the treatment of COVID-19, but has been authorized for emergency use by the FDA.
  • Baricitinib is authorized under an EUA only for the duration of the declaration that circumstances exist justifying the authorization of the EUA of baricitinib under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Under the EUA, baricitinib is available as 1 mg and 2 mg tablets.

IMPORTANT SAFETY INFORMATION

The following provides essential safety information on the unapproved use of baricitinib under the Emergency Use Authorization.

WARNINGS

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 venous thromboembolism is recommended unless contraindicated. If clinical features of deep vein thrombosis or pulmonary embolism occur, patients should be evaluated promptly and treated appropriately.

Abnormal Laboratory Values: Evaluate estimated glomerular filtration rate (eGFR), liver enzymes, and complete blood count at baseline and thereafter according to local patient management practice. Monitor closely when treating patients with abnormal baseline and post-baseline laboratory values. Follow dose adjustments as recommended in the Fact Sheet for Healthcare Providers 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.

There are limited clinical data available for baricitinib use in COVID-19. Additional safety information regarding baricitinib may be found in the full Prescribing Information, including Boxed Warning about Serious Infections, Malignancies, and Thrombosis, and Medication Guide.

USE IN SPECIFIC POPULATIONS

Pregnancy: Baricitinib should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.

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 end-stage renal disease, or have acute kidney injury.

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.

Please see Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers (English) or Fact Sheet for Patients, Parents and Caregivers (Spanish).

BC HCP EUA ISI 19NOV2020

Fact Sheet for Healthcare Providers
Fact Sheet for Patients, Parents and Caregivers (English)
Fact Sheet for Patients, Parents and Caregivers (Spanish)
FDA Letter of Authorization
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