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.
- 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.
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.
Under this EUA, baricitinib is to be used in combination with remdesivir.
Table 1: Dosage Adjustments for Patients with Abnormal Laboratory Values*,b
Laboratory Analyte Laboratory Analyte Value Recommendation Estimated Glomerular Filtration Rate (eGFR) Laboratory Analyte Value:
≥60 mL/min/1.73 m2Recommendation:
- 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 m2Recommendation:
- 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 m2Recommendation:
- 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 m2Recommendation:
Not recommendedAbsolute Lymphocyte Count (ALC) Laboratory Analyte Value:
≥200 cells/µLRecommendation:
Maintain doseAbsolute Lymphocyte Count (ALC) Laboratory Analyte Value:
<200 cells/µLRecommendation:
Consider interruption until ALC is ≥200 cells/µLAbsolute Neutrophil Count (ANC) Laboratory Analyte Value:
≥500 cells/µLRecommendation:
Maintain doseAbsolute Neutrophil Count (ANC) Laboratory Analyte Value:
<500 cells/µLRecommendation:
Consider interruption until ANC is ≥500 cells/µLAminotransferases Laboratory Analyte Value:
If increases in ALT or AST are observed and drug-induced liver injury (DILI) is suspectedRecommendation:
Interrupt baricitinib until the diagnosis of DILI is excluded*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.
bAbbreviations: ALT=alanine transaminase; AST=aspartate transaminase; DILI=drug induced liver injury.
- 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.
There is currently limited information on the use of baricitinib in combination with systemic corticosteroids for treating patients with COVID-19. However, use of baricitinib in patients receiving systemic corticosteroids is not precluded.
In ACTT-2, all patients received standard supportive care at the trial site hospital. If a hospital had a written policy for COVID-19 treatments, patients could receive those treatments. In the absence of a written policy, other experimental treatment and off-label use of marketed medications intended as specific treatment for COVID-19 were prohibited. This included corticosteroids, which were permitted only for standard indications such as adrenal insufficiency, asthma exacerbation, laryngeal edema, septic shock, and acute respiratory distress syndrome.
There were 223 patients who received corticosteroids for clinical indications during the trial.
- 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.
Please see more information on Lilly's Global COVID-19 Response here.