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Para consultar la información para prescribir completa de Olumiant® (Baricitinib) de clic en el siguiente enlace:
Información para prescribir
La información es proporcionada en respuesta a su solicitud, y puede contener datos relacionados a dosis, usos, formulaciones y poblaciones diferentes a la Información para Prescribir del producto. Consulte la Información para Prescribir en la liga que aparece arriba.
Baricitinib: Alternative Administration and Extemporaneous Preparation
Baricitinib tablets are indicated for oral administration for the treatment of moderate to severe rheumatoid arthritis.
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
Eli Lilly and Companyrecommends 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
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
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 NasogastricTube Administration
For patients who are unable to swallow whole BARI tablets, the following alternate methods of administration may be considered including
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-mgand/or2-mgBARItablets, or any combination of tablets necessary to achieve the desired dose up to4-mg may be
placed in a container with approximately 10 mL (5 mL minimum) of room temperature water,
For patients with a gastrostomy feeding tube, 1-mgand/or2-mg BARItablets, or any combination of tablets necessary to achieve the desired dose up to4-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 syringeandimmediately administer through the gastric feeding tube.3
For patients with an enteral feeding tube, 1-mgand/or2-mgBARItablets, 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 administerthrough 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
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
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.
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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