BARICITINIB tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

baricitinib (UNII: ISP4442I3Y) (baricitinib - UNII:ISP4442I3Y)

Available from:

Eli Lilly and Company

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Summary of Product characteristics

BARICITINIB- BARICITINIB TABLET, FILM COATED
ELI LILLY AND COMPANY
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BARICITINIB TABLETS, FOR ORAL USE
EMERGENCY USE AUTHORIZATION
FACT SHEET FOR HEALTHCARE PROVIDERS
EMERGENCY USE AUTHORIZATION (EUA) OF BARICITINIB
The U.S. Food and Drug Administration (FDA) has issued an Emergency
Use Authorization (EUA) to permit the
emergency use of baricitinib 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 been authorized by FDA for the emergency uses
described above. Baricitinib is not FDA-
approved for these uses.
Baricitinib is authorized 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.
THIS EUA IS FOR THE UNAPPROVED 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 ECMO.
BARICITINIB IS ADMINISTERED ORALLY.
To request baricitinib under Emergency Use Authorization (EUA):
In-patient pharmacies may order directly
from an Authorized Distributor of Record. A current list of Lilly's
Authorized Distributors of Record is available
at www.lillytrade.com or visit www.baricitinibemergencyuse.com for
additional access information.
The prescribing healthcare provider and/or the provider's designee
is/are responsible for mandatory 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.
See specific reporting instructions below.
The recommended dosage of baricitinib under the EUA is:
Pediatric patients 9 years of age and older: 4 mg once daily
Pediatric