Olumiant® (Baricitinib)

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Baricitinib: Alternative Administration and Extemporaneous Preparation

Baricitinib tablets are indicated for oral administration for the treatment of moderate to severe rheumatoid arthritis.

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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.1

Tablet Splitting

Eli Lilly and Company recommends that BARI tablets not be split or broken in half.1

Baricitinib tablets are not scored and are not designed to be split or divided into smaller doses. Patients may not get the dose prescribed by their physicians if the tablet is split into smaller doses. 1

Tablet Crushing

Baricitinib tablets are film-coated, immediate-release tablets and are not designed to be crushed.

  • Crushing or breaking the tablet may lead to exposure to the inner tablet contents (eg, powder).
  • The safety information indicates that repeated exposure to BARI powder may damage fertility or the unborn child.
  • Prolonged or repeated exposure may also cause reproductive or specific target organ toxicity (ie, bone marrow, lymphoid system).1

However, if healthcare workers crush the tablets for alternative administration purposes, the 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 SDS for guidance on protective measures and controls to minimize exposure.2

Intravenous Administration

Baricitinib is approved for oral administration only; it is not a sterile product intended for intravenous administration.1

Tablet Dispersion for Oral, Gastrostomy Tube, and Nasogastric Tube 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.3

Preparation for Tablet Dispersion

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).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.3

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).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.3

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.3

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).3

Administration Via Nasogastric Feeding Tube

For patients with an enteral 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.3

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.3

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).3 

Stability and Dispersion Volumes

Dispersed tablets are stable in water for up to 4 hours.3

Dispersion and Rinse Volume for Alternate Administration3

Administration Via 

Dispersion Volume (mL)

Container Rinse Volume (mL)

Oral dispersion 

10

10

Gastrostomy (G) tube

15

15

Nasogastric (NG) tube 

30

15

Extemporaneous Preparation

Dispersing of a BARI tablet has been studied by Lilly with

  • whole milk
  • water
  • green tea, and
  • miso soup.1

In Japan, in addition to the above beverages and food, the dispersing of a BARI tablet in Ryukakusan jelly was also tested.1

In 5 to 10 mL of liquid, the tablet will disperse in a few minutes. 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.1

Testing results demonstrated that dispersing a BARI tablet with the beverages or beverage and food mixture listed above is stable for up to 48 hours.1

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.1

Patients should not try to prepare several doses 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.1

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.1

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. Center for Disease Control and Prevention website. https://www.cdc.gov/niosh/docs/2004-165/. Published 2016. Accessed July 19, 2019.

3U. S. Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers. Emergency Use Authorization (EUA) of Baricitinib. 2020.

Glossary

BARI = baricitinib

CDC = Centers for Disease Control and Prevention

Lilly = Eli Lilly and Company

SDS = Safety Data Sheet

Fecha de la última revisión: 2020 M12 21


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