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Baricitinib
Olumiant® (baricitinib) tablets
1mg, 2mg, 4mgbaricitinib
1mg, 2mg, 4mgThis 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 baricitinib in adult patients with COVID-19 is 4 mg once daily for up to 14 days or until hospital discharge, whichever is first.
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, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.1
Contraindications
There are no known contraindications for baricitinib.1
Recommendations Prior to Treatment Initiation
Prior to baricitinib treatment initiation, consider performing the following
- evaluate for active and latent tuberculosis (TB) infection
- screen for hepatitis in accordance with clinical guidelines
- assess baseline values of complete blood counts, hepatic function, and renal function to determine appropriate use and dose (see Treatment Modification Recommendations Due to Laboratory Abnormalities).1
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 TB
- absolute lymphocyte count <200 cells/μL
- absolute neutrophil count <500 cells/μL, or
- end-stage renal disease, acute kidney injury (estimated glomerular filtration rate<15 mL/min/1.73m2), or on dialysis.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.
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; ESRD = end-stage renal disease.
No dose adjustment is necessary in patients with mild or moderate hepatic impairment. 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
Dose Modifications When Coadministered With Other Medications
Concomitant Medication |
Recommendation |
Strong OAT3 Inhibitors (e.g. probenecid) |
If the recommended baricitinib dose is:
|
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 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 G 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
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.
Enclosed Prescribing Information
References
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 07, 2024