Fecal Microbiota, Live Dosage

Usual Adult Dose for Clostridial Infection

Usual dose: 150 mL rectally as a single dose

Comment:

• This drug should be administered 24 to 72 hours following the last dose of antibiotics for Clostridioides difficile infection (CDI).

Use: Prevention of recurrence of CDI following antibiotic treatment for recurrent CDI.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Data not available

Precautions

CONTRAINDICATION:

• Patients with a history of severe allergic reactions to any ingredient of this drug product.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Only for rectal administration.
• Refer to manufacturer product information for detailed information on the recommended administration technique for this drug.

Storage requirements:

• Original carton of the drug should be stored in an ultracold freezer at -60C to -90C (-76F to -130F).
• This drug can be stored refrigerated at 2C to 8C (36F to 46F) for up to 5 days, including thawing time.
• The administration set should be stored at 10C to 34C (50F to 93F). Do not freeze.

Reconstitution/preparation techniques:

• Before administration, this drug should be thawed by refrigerating at 2C to 8C (36F to 46F) for 24 hours.
• Alternatively, this drug can be kept refrigerated at 2C to 8C (36F to 46F) and used within 5 days, including thawing time.
• Do not refreeze after thawing.
• A heat source such as a microwave or hot water should not be used for thawing.
• Refer to manufacturer product information for detailed information for preparation of this drug.

General:

• This drug is not indicated for the treatment of CDI.
• Properly dispose of the remnants of this product in medical waste.

Patient advice:

• Patients should be informed that this drug is made from human fecal matter and may have food allergens.
• Notify physician or healthcare professional if patient experiences persistent diarrhea (3 or more loose bowel movements within a 24-hour period for 2 consecutive days) following administration of this drug.
• Do not take any oral antibiotic for 8 weeks following administration of this drug, unless directed by a physician.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer