Rebyota (fecal microbiota, live-jslm)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

*For rectal administration only.

*Prior to use, thaw fecal microbiota, live-jslm completely by placing the carton in a refrigerator, 2degreesC to 8degreesC (36degreesF to 46degreesF), for approximately 24 hours. The carton may be stored in the refrigerator at 2degreesC to 8degreesC (36degreesF to 46degreesF) and used within 5 days, including thawing time. DO NOT thaw using a heat source such as a microwave or hot water.

*Administer fecal microbiota, live-jslm 24 to 72 hours after the last dose of antibiotics for CDI.

*Administer a single dose of 150 mL rectally.

*Consult the full prescribing information for additional information on preparation and administration of fecal microbiota, live-jslm.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Fecal Microbiota/Antibiotics

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Fecal microbiota is a suspension of live bacteria, which may be compromised by concurrent use of antibiotics.(1)

CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota. Antibacterial treatment should be completed for 24 to 72 hours before initiating treatment with fecal microbiota. Do not use antibiotics for up to 8 weeks after fecal microbiota.(1)

DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Severe allergic reactions (e.g. anaphylaxis) to any component of fecal microbiota, live-jslm.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

The most commonly reported (>=3%) adverse reactions occurring in adults following a single dose of fecal microbiota, live-jslm were abdominal pain, (8.9%), diarrhea (7.2%), abdominal distention (3.9%), flatulence (3.3%), and nausea (3.3%).

There are no severe adverse reactions for this drug.

More Frequent

• Acute abdominal pain
• Diarrhea

Less Frequent

• Abdominal distension
• Flatulence
• Nausea

No enhanced messaging available.

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

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.