Fecal microbiota, live is a bacterial spore suspension in capsules for oral administration and a rectal microbiota suspension indicated for the prevention of recurrence of C. difficile infection (CDI) after antibiotic treatment for recurrent CDI. It is not indicated for the treatment of CDI. Fecal microbiota, live is manufactured from human fecal matter sourced from qualified donors. Rectal fecal microbiota, live is administered 24 to 72 hours after the conclusion of antibiotic treatment for CDI with oral antibiotics being avoided for up to 8 weeks after use. Oral fecal microbiota, live is administered 48 to 96 hours after the conclusion of antibiotic treatment for CDI with antibiotics to be avoided during use. Gastrointestinal adverse events are associated with use.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Oral Administration
Oral Solid Formulations
-On the day before and at least 8 hours prior to taking the first dose, administer 296 mL (10 oz) of magnesium citrate orally.
-Avoid any food or drink, except for a small amount of water, for at least 8 hours prior to taking the first dose.
-Administer each dose on an empty stomach prior to the first meal of the day.
Rectal Administration
Preparation of the Fecal Microbiota Product
-Prior to use, thaw fecal microbiota, live completely by placing the carton in a refrigerator for approximately 24 hours.
-Do not thaw using a heat source, such as a microwave or hot water.
-Condensation is normal after thawing.
-Storage: May be stored in the refrigerator, 2 to 8 degrees C (36 to 46 degrees F) and used within 5 days, including thawing time. Do not refreeze after thawing.
Preparation of the Administration Set
-Remove the thawed fecal microbiota, live carton from the refrigerator. Remove the bag containing the thawed product from the outer carton and the inner carton insert. Do not remove the bag containing thawed fecal microbiota, live from the sealed outer bag.
-Open the administration set and close the pinch clamp by pushing the clamp until it is fully closed.
-Remove the tab from the spike port of the bag containing thawed fecal microbiota, live and remove the cap from the administration tube spike.
-Insert the tube spike through the spike port of the bag containing thawed fecal microbiota, live.
-Do not remove air from the administration tube prior to insertion to avoid loss of product.
-Storage: Store the administration set at 10 to 34 degrees C (50 to 93 degrees F). Do not store the administration set in the freezer.
Administration
-Prepare the person for administration by requesting they empty their bladder and bowel, if possible.
-Place the person in the left-side position or the knee-chest position with a disposable underpad beneath the person.
-Apply water-soluble lubricant to the administration tube tip and gently insert the administration tube tip into the rectum about 12 cm (5 inches) in a direction pointed slightly toward the navel (umbilicus).
-Hold the administration tube in place for the entire procedure to maintain the tube position in the rectum.
-With the other hand, open the pinch clamp on the administration tube, and then gradually raise the bag to allow delivery of the product via gravity flow.
-Do not allow the administration tube to sag or loop as this will prevent the entire dose from being delivered.
-Do not squeeze the bag to deliver the product as this could be uncomfortable for the person.
-Do not hang the bag from an IV stand.
-When the entire dose has been delivered, close the pinch clamp and then slowly withdraw the tube.
-Some fecal microbiota, live will remain in the tube after administration. Take care to prevent any residual material remaining in the tube from leaking out.
-Keep the patient in the left-side position or the knee-chest position for up to 15 minutes to minimize any cramping that may occur.
-There are no restrictions on the person's use of the restroom.
-Dispose of all components in medical waste.
Gastrointestinal adverse reactions reported with rectal fecal microbiota, live include abdominal distention (3.9%), abdominal pain (8.9%), diarrhea (7.2%), flatulence (3.3%), and nausea (3.3%). Abdominal distention (31.1%), constipation (14.4%), diarrhea (3.4% to 10%), flatulence (4.2%), and nausea (3%) have been reported with oral fecal microbiota, live. Advise persons to notify their health care provider if persistent diarrhea, defined as 3 or more loose bowel movements within a 24-hour period for 2 consecutive days, returns after fecal microbiota, live administration.
General adverse reactions reported with oral fecal microbiota, live include fatigue (22.2%) and chills (11.1%).
Do not administer fecal microbiota, live to persons with a history of a severe allergic reaction (e.g. anaphylaxis) to any of the known product components. Appropriate medical treatment must be immediately available in the event an acute anaphylactic reaction occurs.
Fecal microbiota, live is manufactured from human fecal matter and may contain food allergens. Donors do not have dietary restrictions with respect to potential food allergens. The potential for adverse reactions due to food allergens is unknown.
Fecal microbiota, live is manufactured from human fecal matter and may carry a risk of transmitting infectious agents. The fecal matter is tested for a panel of transmissible pathogens. Any infection suspected to have possibly been transmitted by this product should be reported to the manufacturer.
Fecal microbiota, live is not absorbed systemically after rectal administration; therefore, use during pregnancy is not expected to result in fetal exposure. There are no data on the use of the oral fecal microbiota, live in pregnant persons or animals.
Fecal microbiota, live is not absorbed systemically after rectal administration; therefore, breast-feeding is not expected to result in exposure of the child to fecal microbiota, live. It is not known if fecal microbiota, live is excreted in human milk after oral administration. Data are not available to assess the effects of oral fecal microbiota, live on the breast-fed infant or on milk production/excretion. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for oral fecal microbiota, live and any other potential adverse effects on the breast-fed child from fecal microbiota, live or the underlying maternal condition.
For secondary C. difficile infection prophylaxis after antibiotic treatment for recurrent C. difficile infection (CDI):
Oral dosage:
Adults: 4 capsules PO once daily for 3 days starting 48 to 96 hours after the last dose of antibiotics for C. difficile infection (CDI). Avoid antibiotic therapy during use. Fecal microbiota transplantation may be considered in persons with second/subsequent episodes of pseudomembranous colitis due to CDI or in those with fulminant/refractory disease.
Rectal dosage:
Adults: 150 mL rectally as a single dose administered 24 to 72 hours after the last dose of antibiotics for C. difficile infection (CDI). Avoid oral antibiotic therapy for up to 8 weeks after administration. Fecal microbiota transplantation may be considered in persons with second/subsequent episodes of pseudomembranous colitis due to CDI or in those with fulminant/refractory disease.
Maximum Dosage Limits:
-Adults
4 capsules/day PO; 150 mL rectally as a single dose.
-Geriatric
4 capsules/day PO; 150 mL rectally as a single dose.
-Adolescents
Safety and efficacy have not been established.
-Children
Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Fecal Microbiota, Live products.
The mechanism of action of fecal microbiota, live has not been established. Each 150 mL of the rectal suspension contains between 1 x 108 and 5 x 1010 colony forming units (CFU) per mL of fecal microbes including more than 1 x105 CFU/mL of Bacteroides sp. Each oral capsule contains between 1 x 106 and 3 x 107 Firmicutes spore colony forming units.
Fecal microbiota, live is administered orally and rectally. No pharmacokinetic data are available.
Affected cytochrome P450 isoenzymes and drug transporters: none