Baricitinib

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

What is the recommended baricitinib dose for the treatment of COVID-19?

The recommended dose of BARI in adult patients with COVID-19 is 4 mg once daily for up to 14 days of total treatment or until hospital discharge, whichever is first.

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Baricitinib Emergency Use Authorization

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 Fact Sheet for Healthcare Professionals

Contraindications

There are no known contraindications for BARI.1

Baricitinib Dosing for Patients With COVID-19

Patient Selection

Baseline eGFR, liver enzymes, and complete blood count should be evaluated to determine treatment suitability and dose.1 Monitor patients with abnormal baseline and postbaseline laboratory values closely.1

See Dosage Adjustments for Patients With Abnormal Laboratory Values for dosage adjustments for patients with laboratory abnormalities. 

Baricitinib is not recommended for

  • patients who are on dialysis, have end-stage renal disease (EGFR <15 mL/min/1.73 m2) or have acute kidney injury, or
  • patients with known active tuberculosis.1

Recommended Dose

Adult Patients

The recommended dosage of BARI in adults with eGFR ≥60 mL/min/1.73 m2 is 4 mg once daily for 14 days of total treatment or until hospital discharge, whichever is first.1

In hospitalized patients with COVID-19, prophylaxis for venous thromboembolism is recommended unless contraindicated.1

Pediatric Patients

Limited data informing BARI dosing in pediatric patients comes from ongoing clinical trials for other uses.1

Based on the available information, treatment for COVID-19 in pediatric population under this EUA is as follows:

  • The recommended dosage for patients 9 years of age and older is 4 mg once daily for 14 days of total treatment or until hospital discharge, whichever is first.
  • The recommended dosage for patients ages 2 years through less than 9 years of age is 2 mg once daily for 14 days of total treatment or until hospital discharge, whichever is first.
  • Baricitinib is not authorized for patients younger than 2 years of age.1

Dosage adjustments in patients with renal or hepatic impairment are recommended.1

Dose Adjustments for Patients With Abnormal Laboratory Values

Dose adjustments for patients with abnormal laboratory values are provided in Dosage Adjustments for Patients With Abnormal Laboratory Values.

Dosage Adjustments for Patients With Abnormal Laboratory Values1

Laboratory Analytea

Laboratory Analyte Value

Recommendation

eGFR



≥60 mL/min/1.73 m2

  • Adults and pediatric patients ≥9 years of age: 4 mg once daily
  • Pediatrics, aged 2 to <9 years: 2 mg once daily

30 to <60 mL/min/1.73 m2

  • Adults and pediatric patients ≥9 years of age: 2 mg once daily
  • Pediatrics, aged 2 to <9 years: 1 mgb once daily

15 to <30 mL/min/1.73 m2

  • Adults and pediatric patients ≥9 years of age: 1 mgb once daily
  • Pediatrics, aged 2 to <9 years: Not recommended

<15 mL/min/1.73 m2

  • Not recommended

ALC

≥200 cells/µL

  • Maintain dose

<200 cells/µL

  • Consider interruption until ALC is ≥200 cells/µL

ANC

≥500 cells/µL

  • Maintain dose

<500 cells/µL

  • Consider interruption until ANC is ≥500 cells/µL

Aminotransferases

If increases in ALT or AST are observed and DILI is suspected

  • Interrupt BARI until the diagnosis of DILI is excluded

Abbreviations: ALC = absolute lymphocyte count; ALT = alanine transaminase; ANC = absolute neutrophil count; AST = aspartate transaminase; BARI = baricitinib; DILI = drug-induced liver injury; eGFR = estimated glomerular filtration rate.

aIf 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.

bOnly if a 1 mg tablet is not available, a 2 mg tablet can be split using a tablet splitter that has a razor blade to administer half a 2 mg tablet once daily. The tablet should be split along the longest diameter. If the portions of the tablet are determined to be visually unequal they should be discarded. Take care in storing the second tablet half to avoid breakage prior to next dose.

Dosage Adjustments when Coadministered with Other Medications

Dosage Adjustment when Coadministered with Other Medications1

Concomitant Medication

Recommendation

Strong OAT3 Inhibitors (e.g. probenecid)

If the recommended baricitinib dose is:

  • 4 mg once daily, reduce dose to 2 mg once daily 
  • 2 mg once daily, reduce dose to 1 mga once daily
  • 1 mga once daily, consider discontinuing probenecid.

 Abbreviation: OAT3 = organic anion transporter 3

aOnly if a 1 mg tablet is not available, a 2 mg tablet can be split using a tablet splitter that has a razor blade to administer half a 2 mg tablet once daily. The tablet should be split along the longest diameter. If the portions of the tablet are determined to be visually unequal they should be discarded. Take care in storing the second tablet half to avoid breakage prior to next dose.

Baricitinib Administration in Patients With COVID-19

Baricitinib tablets are given orally once daily with or without food.1

Alternate Administration

For patients who are unable to swallow whole BARI tablets, the following alternate methods of administration may be considered including

  • oral dispersion
  • gastrostomy (G) tube, and
  • nasogastric (NG) tube.1

No information on post-pyloric administration of BARI is available as this has not been studied by Lilly.

Pharmacokinetics Related to Alternate Administration

The pharmacokinetics in patients with COVID-19 who are intubated and have BARI administered via NG tube is similar to that in healthy subjects. The half-life of BARI in healthy subjects is approximately 10 hours.1

Given BARI’s short tmax and what is understood about the transit time of oral drugs in the small intestine, it is anticipated that much of the absorption occurs in the upper gastrointestinal tract.2

Preparation for Alternate Administration

Intact tablets are not hazardous. Tablets may be crushed to facilitate dispersion. It is not known if powder from the crushed tablets may constitute a reproductive hazard to the preparer. Use proper control measures (ie, ventilated enclosure) or personal protective equipment (ie, N95 respirator) to prevent (airborne) powder coming into contact with the preparer.1,3

Although dispersing the tablet under liquid may reduce exposure via inhalation or dermal route, preparation recommendations remain unchanged.3

Oral Administration of Dispersed Tablets in Water

For patients who are unable to swallow whole tablets, 1-mg and/or 2-mg BARI tablets, or any combination of tablets necessary to achieve the desired dose up to 4-mg may be

  • placed in a container with approximately 10 mL (5 mL minimum) of room temperature water,
  • dispersed by gently swirling the tablets, and
  • immediately taken orally.1

The container should be rinsed with an additional 10 mL (5 mL minimum) of room temperature water and the entire contents swallowed by the patient (see Dispersion and Rinse Volume for Alternate Administration).1

The tablet as a whole will not dissolve to a clear solution as it contains ingredients that are not water soluble.3

Administration via Gastrostomy Feeding Tube

For patients with a gastrostomy feeding tube, 1-mg and/or 2-mg BARI tablets, or any combination of tablets necessary to achieve the desired dose up to 4-mg may be placed in a container with approximately 15 mL (10 mL minimum) of room temperature water and dispersed with gentle swirling.1

Ensure the tablets are sufficiently dispersed to allow free passage through the tip of the syringe. Withdraw entire contents from the container into an appropriate syringe and immediately administer through the gastric feeding tube.1

Rinse container with approximately 15 mL (10 mL minimum) of room temperature water, withdraw the contents into the syringe, and administer through the tube (see Dispersion and Rinse Volume for Alternate Administration).1

Administration via Nasogastric Feeding Tube

For patients with a nasogastric feeding tube, 1-mg and/or 2-mg BARI tablets, or a combination of tablets necessary to achieve the desired dose may be placed into a container with approximately 30 mL of room temperature water and dispersed with gentle swirling.1

Ensure the tablets are sufficiently dispersed to allow free passage through the tip of the syringe. Withdraw the entire contents from the container into an appropriate syringe and immediately administer through the enteral feeding tube. To avoid clogging of small diameter tubes (smaller than 12 Fr), the syringe can be held horizontally and shaken during administration.1

Rinse container with a sufficient amount (minimum of 15 mL) of room temperature water, withdraw the contents into the syringe, and administer through the tube (see Dispersion and Rinse Volume for Alternate Administration).1 

Stability and Dispersion Volumes

Dispersed tablets are stable in water for up to 4 hours.1

Dispersion and Rinse Volume for Alternate Administration1

Administration Via 

Dispersion Volume (mL)

Container Rinse Volume (mL)

Oral dispersion 

10

10

Gastrostomy (G) tube

15

15

Nasogastric (NG) tube 

30

15

Reference

1U. S. Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers. Emergency Use Authorization (EUA) of Baricitinib. 2021.

2Wilson CG. The organization of the gut and the oral absorption of drugs: anatomical, biological, and physiological considerations in oral formulation development. In: Wilson CG, Crowley PJ, eds. Controlled Release in Oral Drug Delivery. 1st ed. Springer US (Online); 2011:27-48. http://dx.doi.org/10.1007/978-1-4614-1004-1

3Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

BARI = baricitinib

COVID-19 = coronavirus disease 2019

ECMO = extracorporeal membrane oxygenation

eGFR = estimated glomerular filtration rate

EUA = Emergency Use Authorization

FDA = Food and Drug Administration

Date of Last Review: October 07, 2021


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