Rebyota

Drug overview for REBYOTA (fecal microbiota, live-jslm):

Generic name: fecal microbiota, live-jslm
Drug class: Fecal Microbiota Therapies
Therapeutic class: Gastrointestinal Therapy Agents

Fecal microbiota, live-jslm is a fecal microbiota suspension.

No enhanced Uses information available for this drug.

DRUG IMAGES

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The following indications for REBYOTA (fecal microbiota, live-jslm) have been approved by the FDA:

Indications:
Recurrent Clostridioides difficile infection

Professional Synonyms:
None.

Dosing information for REBYOTA
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
REBYOTA RECTAL SUSPENSION	Maintenance	Adults insert 150 milliliters by rectal route once

Moderate List
No disease contraindications

More Frequent	Less Frequent
Acute abdominal pain Diarrhea	Abdominal distension Flatulence Nausea

Rare/Very Rare
None.

The following precautions are available for REBYOTA (fecal microbiota, live-jslm):

Pediatric
Pregnant
Lactation
Geriatric

Safety and effectiveness of fecal microbiota, live-jslm in individuals younger than 18 years of age have not been established.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Fecal microbiota, live-jslm is not absorbed systemically following rectal administration, and maternal use is not expected to result in fetal exposure to the drug.

Fecal microbiota, live-jslm is not absorbed systemically by the mother following rectal administration, and breastfeeding is not expected to result in exposure of the child to fecal microbiota, live-jslm.

Of the 978 adults who received fecal microbiota, live-jslm, 48.8% were 65 years of age and over (n=477), and 25.7% were 75 years of age and over (n=251). Data from clinical studies of fecal microbiota, live-jslm are not sufficient to determine if adults 65 years of age and older respond differently than younger adults.

Recurrent clostridioides difficile infection
A04.71	Enterocolitis due to clostridium difficile, recurrent