Important Information
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 COVID-19 in hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
- Baricitinib is authorized for use under an Emergency Use Authorization (EUA) for treatment of coronavirus disease 2019 (COVID-19) in hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
- Baricitinib has not been approved, but has been authorized for emergency use by the FDA for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
- Baricitinib is authorized under an Emergency Use Authorization (EUA) 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.
- 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, Fact Sheet for Patients, Parents and Caregivers (English) and Fact Sheet for Patients, Parents and Caregivers (Spanish).
Additional Information for Healthcare Providers
- Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of baricitinib in hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) and mandatory requirements of the EUA.
- Healthcare providers should provide a copy of the Fact Sheet for Patients, Parents and Caregivers to patients and/or caregivers prior to treatment
- The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory FDA MedWatch reporting of all serious adverse events and medication errors potentially related to baricitinib within 7 calendar days from the healthcare provider’s awareness of the event.
MedWatch adverse event reports can be submitted to the FDA online here, or by calling 1-800-FDA-1088.
For information on the approved use of baricitinib in COVID-19, click here.
ACCESS
Baricitinib is available as 1 mg and 2 mg tablets for use in COVID-19, and is available to inpatient facilities through Lilly’s Authorized Specialty Distributors. To review a complete list,
click here.