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How is baricitinib supplied for the treatment of COVID-19
Baricitinib is supplied as 1-mg, 2-mg, and 4-mg tablets for the emergency use of treatment of COVID-19 in hospitalized patients..
Baricitinib Emergency Use Authorization for COVID-19
Baricitinib has not been approved, but has been authorized for emergency use by FDA 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.
Baricitinib is authorized 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 only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the 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, and Fact Sheet for Patients/Caregivers at baricitinibemergencyuse.com.
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.1
Under this emergency use authorization, baricitinib is supplied in 30 count bottles as follows:
- OLUMIANT (baricitinib) tablet 1 mg (NDC 0002-4732-30)
- OLUMIANT (baricitinib) tablet 2 mg (NDC 0002-4182-30), and
- baricitinib tablet 4 mg (NDC 0002-6885-30).1
Storage and Handling
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).1
Enclosed Fact Sheet
1U. S. Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers. Emergency Use Authorization (EUA) of Baricitinib. 2021.
Date of Last Review: November 08, 2021