Emergency Use Authorization (EUA) for the Treatment of COVID-19 in Certain Hospitalized Pediatric Patients 2 to less than 18 years of age

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

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.

AUTHORIZED USE

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 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.

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

There are limited clinical data available for baricitinib in pediatric patients 2 to less than 18 years of age hospitalized with COVID-19 requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.

Serious Infections: There is limited information regarding use of baricitinib in patients with COVID-19 and concomitant active serious infections.

Serious infections, including viral reactivation, have occurred in patients with COVID-19 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: Serious venous thrombosis, including pulmonary embolism have been observed in COVID-19 patients treated with baricitinib and are known adverse drug reactions of baricitinib. If clinical features of deep vein thrombosis or pulmonary embolism occur, patients should be evaluated promptly and treated appropriately.

Abnormal Laboratory Values: There is limited information regarding use of baricitinib in patients with COVID-19 and any of the following clinical findings: absolute neutrophil count (ANC) <1000 cells/mm³, absolute lymphocyte count (ALC) <200 cells/mm³, and hemoglobin <8 g/dL.

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 dosage modifications 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 and Medication Guide for additional information on risks associated with baricitinib treatment.

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.

ADVERSE REACTIONS

During the first 29 days in COVID-19 clinical trials, adverse reactions that occurred in ≥1% of patients treated with baricitinib vs placebo, respectively, were alanine aminotransferase (ALT) ≥3 x upper limit of normal (ULN) (18.1% vs 16.0%), aspartate aminotransferase (AST) ≥3 x ULN (11.8% vs 9.4%), thrombocytosis >600,000 cells/mm³ (7.9% vs 4.6%), creatine phosphokinase (CPK) >5 x ULN (4.5% vs 4.7%), neutropenia <1000 cells/mm³ (2.2% vs 1.8%), deep vein thrombosis (1.5% vs 1.4%), pulmonary embolism (1.5% vs 0.8%), and urinary tract infection (1.5% vs 1.0%).

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 11MAY2022