Version May 2024
Clostridioides difficile infection, prophylaxis: Rectal: 150 mL (contents of 1 bag) as a single dose, administered 24 to 72 hours after completion of C. difficile treatment regimen (Ref).
There are no dosage adjustments provided in the manufacturer's labeling; however, not expected to be systemically absorbed.
There are no dosage adjustments provided in the manufacturer's labeling; however, not expected to be systemically absorbed.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
1% to 10%: Gastrointestinal: Abdominal distention (4%), abdominal pain (9%), diarrhea (7%), flatulence (3%), nausea (3%)
Severe hypersensitivity (eg, anaphylaxis) to fecal microbiota (live) or any component of the formulation.
Concerns related to adverse effects:
• Hypersensitivity reactions: Ensure appropriate medical treatment is readily available in the event an acute anaphylactic reaction occurs following administration.
Dosage form specific issues:
• Food allergies: Because product is manufactured from human fecal matter, may contain food allergens; however, potential for the product to cause adverse reactions due to food allergens is unknown.
• Transmissible infectious agents: Manufactured from human fecal matter; may carry risk of transmitting infectious agents. Infections thought to be transmitted by this product should be reported to the manufacturer.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Rectal:
Rebyota: Fecal microbiota, live-jslm 150 mL (150 mL) [contains polyethylene glycol (macrogol)]
No
Suspension (Rebyota Rectal)
150 mL (per mL): $72.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Rectal: Prior to use, thaw completely by placing carton in refrigerator (2°C to 8°C [36°F to 46°F]) for ~24 hours; do not thaw using a heat source (eg, microwave, hot water). Administer via gravity flow using provided administration set; refer to manufacturer's product labeling for more information. Do not allow administration tube to sag or loop (may prevent entire dose from being delivered), do not squeeze the bag to deliver product (may cause patient discomfort), and do not hang bag from an IV stand. Some product will remain in tube after administration is complete. Dispose of all components in medical waste.
Clostridioides difficile infection, prophylaxis: Prevention of recurrence of C. difficile infection (CDI) in patients ≥18 years of age following antibiotic treatment of recurrent CDI.
Limitations of use: Not indicated for treatment of CDI.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Antibiotics: May diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination
Rectal administration is not expected to have systemic absorption; fetal exposure is not expected following maternal administration.
Rectal administration is not expected to have systemic absorption; exposure via breast milk is not expected following maternal administration.
Restoration of intestinal eubiosis (Soveral 2022).
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