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Emergency Use Authorization (EUA) for the Treatment of COVID-19

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).

The Secretary of the Department of Health and Human Services has declared a public health emergency that justifies the emergency use of baricitinib to treat coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 infection. In response, the U.S. Food and Drug Administration (FDA) has issued an EUA for baricitinib for the treatment of COVID-19.

  • 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.
  • For information on the authorized use of baricitinib and mandatory requirements under the EUA, please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents and Caregivers.

Additional Information for Healthcare Providers:

  • Healthcare Providers should provide a copy of the Fact Sheet for Patients, Parents, and Caregivers to patients and/or caregivers prior to treatment.
  • Healthcare Providers and/or their designee are responsible for mandatory FDA MedWatch reporting of all medication errors and serious adverse events or deaths occurring during baricitinib treatment and considered to be potentially attributable to baricitinib. These events must be reported within 7 calendar days from the onset of the event.

MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or online here.

Other Reporting Requirements: Report adverse events or medication errors to Lilly at: 1-855-LillyC19 (1-855-545-5921).

ACCESS
Baricitinib is available as 1 mg and 2 mg tablets for use in COVID-19 for inpatient facilities through Lilly’s Authorized Specialty Distributors. To review the complete list, click here.

EUA Fact Sheets and FDA Letter of Authorization

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

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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