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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.
Can the Olumiant® (baricitinib) tablet be split, crushed, or administered in other ways?
Baricitinib comes in a film-coated tablet designed to be swallowed whole. However, in patients who are unable to swallow tablets, alternate methods of administration may be considered.
See important safety information, including boxed warning, in the attached prescribing information.
Olumiant (baricitinib) Prescribing Information
Recommended Dose in Patients with Rheumatoid Arthritis
The recommended dose for baricitinib in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers is 2 mg once daily with or without food.1
Recommended Dose in Patients with Alopecia Areata
The recommended dosage of baricitinib for the treatment of adult patients with severe alopecia areata (AA) is 2 mg once daily. Increase to 4 mg once daily if the response to treatment is not adequate.1
For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4 mg once daily.1
Once patients achieve an adequate response to treatment with 4 mg, decrease the dosage to 2 mg once daily.1
Recommended Dose in Patients with COVID-19
The recommended dosage of baricitinib in hospitalized adults with COVID-19 is 4 mg once daily orally, with or without food, for 14 days or until hospital discharge, whichever occurs first.1
Alternative Administration
Tablet Chewing
Baricitinib tablets are not designed to be chewed. However, the tablets may be chewed if the patient has a need to do so. Make sure that the entire dose is swallowed if the tablet is chewed.2
Tablet Splitting
Tablet Crushing
Baricitinib tablets are film-coated, immediate-release tablets and are not designed to be crushed. Baricitinib safety information indicates intact tablets are not considered to be a health hazard.
- Crushing or breaking the tablet may lead to exposure to the inner tablet contents (eg, powder).
- The safety information indicates that repeated exposure to baricitinib powder may damage fertility or the unborn child.
- Prolonged or repeated exposure may also cause reproductive or specific target organ toxicity.2
If healthcare workers crush the tablets for alternative administration purposes, the Centers for Disease Control and Prevention (CDC) provides guidance for preventing exposure to hazardous drugs in healthcare settings. According to the CDC, healthcare workers should
- follow local protocols and procedures established at their facility
- utilize the protective measures and controls for the handling of drug associated to a hazardous handling classification, and
- refer to the product material Safety Data Sheet (SDS) for guidance on protective measures and controls to minimize exposure.3
Commercial Availability of Topical, Intravenous, Liquid, and Other Formulations
Baricitinib is currently only commercially available as a tablet and approved for oral administration only.2
Tablet Dispersion for Oral or Feeding Tube Administration
Alternate Administration
For patients who are unable to swallow whole tablets, alternate administration may be considered including
- oral dispersion
- gastrostomy tube (G tube)
- nasogastric tube (NG tube), or
- orogastric tube (OG).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.4
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.1,2
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.2
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.2
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
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.
Extemporaneous Preparation
In 5 to 10 mL of liquid, the tablet is expected to disperse in <5 minutes when taking into consideration the water and various beverages that were studied by Lilly. If desired, a small amount of food may be added to the beverage and medicine mixture. If the tablet is dispersed in a beverage or beverage and food mixture, make sure the entire medicine mixture is taken at one time.2
Dispersing of a baricitinib tablet has been studied by Lilly with
- whole milk
- water
- green tea, and
- miso soup.2
In Japan, in addition to the above beverages and food, the dispersing of a baricitinib tablet in Ryukakusan jelly was also tested.2
Extemporaneous Preparation Dose Delivery
To ensure that the patient receives an accurate dose, only 1 tablet should be dispersed with the beverage or beverage and food mixture. Dispersing the tablet in a small serving size of the beverage or beverage and food mixture will make it easier to drink or eat all of the food/medicine mixture at 1 time. All of the dispersed tablet must be included in the beverage or beverage and food mixture, and the patient must drink or eat all of the mixture.2
Several doses should not be prepared at once by dispersing multiple tablets into beverage or beverage and food mixtures and taking a portion of the resulting mixture for a dose. The patient may not receive the correct dose.2
Study data is not available from Lilly to predict how much of a partial dose the patient may have receive
- if the entire dispersed tablet was not mixed into the food/medicine mixture, or
- if the patient did not drink or eat all of the mixture.2
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.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Center for Disease Control and Prevention, The National Institute for Occupational Safety and Health (NIOSH). Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. February 17, 2018. Accessed May 4, 2022. https://www.cdc.gov/niosh/docs/2004-165/
4Wilson 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
Date of Last Review: July 31, 2023