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 Olumiant® (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 or until hospital discharge, whichever is first.

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See important safety information, including boxed warning, in the attached prescribing information.

Olumiant® (baricitinib) Prescribing Information

COVID-19 Indication

Baricitinib is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).1 

Contraindications

There are no known contraindications for baricitinib.1

Recommendations Prior to Treatment Initiation

Prior to baricitinib treatment initiation, consider performing the following 

Monitor complete blood counts during treatment and modify dosage as recommended (see Treatment Modification Recommendations Due to Laboratory Abnormalities).1

Baricitinib is not recommended for patients with

  • active tuberculosis
  • absolute lymphocyte count (ALC) <200 cells/μL
  • absolute neutrophil count (ANC) <500 cells/μL, or
  • end-state renal disease (ESRD), acute kidney injury (eGFR <15 mL/min/1.73m2 ), or on dialysis.1

It is not known if dosage adjustment is needed in patients with COVID-19 and severe hepatic impairment. Baricitinib should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk.1

Baricitinib Dosing for Adult Patients With COVID-19

Recommended Dose

The recommended dosage of baricitinib in adults is 4 mg once daily orally, with or without food, for 14 days or until hospital discharge, whichever occurs first.1

An alternative administration for patients unable to swallow tablets may be used (see Alternate Administration).1

Dose Modifications Due to Laboratory Abnormalities

Dose adjustments for patients with abnormal laboratory values are provided in Treatment Modification Recommendations Due to Laboratory Abnormalities.

Treatment Modification Recommendations Due to Laboratory Abnormalities1

Laboratory Value

Recommendation

Cytopenias

ALC

≥200 cells/µL

Maintain dose

<200 cells/µL

Interrupt baricitinib until ALC ≥200 cells/µL 

ANC

≥500 cells/µL

Maintain dose

<500 cells/µL

Interrupt baricitinib until ANC ≥500 cells/µL 

Renal Impairment Stage, eGFR

Mild

60 to 89 mL/min/1.73 m2

4 mg once daily

Moderate

30 to 59 mL/min/1.73 m2

2 mg once daily

Severe

15 to 29 mL/min/1.73 m2

1 mg once daily

ESRD, patients on dialysis, or acute kidney injury

<15 mL/min/1.73 m2

Not recommended

Hepatic Impairment

Aminotransferases

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

Interrupt baricitinib until the diagnosis of DILI is excluded

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

No dose adjustment is necessary in patients with mild or moderate hepatic impairment.1

Dose Modifications 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 mg once daily
  • 1 mg once daily, consider discontinuing probenecid.

 Abbreviation: OAT3 = organic anion transporter 3

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 baricitinib tablets, the following alternate methods of administration may be considered including

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

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

Pharmacokinetics Related to Alternate Administration

The total body clearance and half-life of baricitinib is 14.2 L/h and 10.8 hours, respectively, in patients with COVID-19 who are intubated and have baricitinib administered via NG or OG tube.1

Given baricitinib's short time of maximum observed drug concentration (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. If tablets are crushed, 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

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

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, 2-mg, or 4-mg baricitinib 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 Alternative 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, 2-mg, or 4-mg baricitinib 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 Alternative Administration).1

Administration via Nasogastric or Orogastric Feeding Tube

For patients with a NG or OG feeding tube, 1-mg, 2-mg, or 4-mg baricitinib tablets, or a combination of tablets necessary to achieve the desired dose up to 4-mg 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 Alternative Administration).1 

Stability and Dispersion Volumes

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

Dispersion and Rinse Volume for Alternative Administration1

Administration Via 

Dispersion Volume (mL)

Container Rinse Volume (mL)

Oral dispersion 

10

10

G tube

15

15

NG tube or OG tube

30

15

Abbreviations: G tube = gastrostomy tube; NG = nasogastric tube; OG = orogastric tube.

Reference

The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).

1Olumiant [package insert]. Indianapolis, IN: Eli Lilly and Company; 2022.

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.

Date of Last Review: May 12, 2022


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