microbiota rectal (Rx)

1-10%

Abdominal pain (8.9%)

Diarrhea (7.2%)

Abdominal distension (3.9%)

Flatulence (3.3%)

Nausea (3.3%)

Contraindications

History of severe allergic reaction (eg, anaphylaxis) to any of the known product components

Cautions

Patients should notify physician if persistent diarrhea, defined as 3 or more loose bowel movements within a 24-hr period for 2 consecutive days, returns following product administration

Instruct patients not to take any oral antibiotic therapy for up to 8 weeks after product administration unless directed by their physician

Transmissible infectious agents

• Suspension may carry risk of transmitting infection since it is manufactured from human fecal matter
• Any infection suspected by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Ferring Pharmaceuticals Inc

Acute allergic reaction

• Administer in facility where appropriate medical treatment is immediately available in event of acute anaphylactic reaction

Food allergens

• Manufactured from human fecal matter and may contain food allergens
• Potential for microbiota to cause adverse reactions due to food allergens is unknown

Pregnancy

Not absorbed systemically following rectal administration, and maternal use is not expected to result in fetal exposure

Lactation

Not absorbed systemically by the mother following rectal administration, and breastfeeding is not expected to result in exposure of the child

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Microbiota-based live biotherapeutic is delivered rectally to provide a broad consortium of diverse microbes to the gut to reduce recurrent C difficile infection after antibiotic treatment

Mechanism of action not established

Preparation

Prior to use, thaw completely by placing carton in refrigerator at 2-8ºC (36-46ºF) for ~24 hr; do not refreeze after thawing

Carton may be stored in refrigerator at 2-8ºC (36-46ºF) and used within 5 days, including thawing time

DO NOT thaw using a heat source (eg, microwave, hot water)

Condensation is normal after thawing

Remove thawed carton from refrigerator, then remove the bag containing thawed microbiota from outer carton and the inner carton insert

DO NOT remove the bag containing thawed microbiota from the sealed outer bag

Locate an administration set (supplied), water-soluble lubricant (not included), and disposable underpad (not included)

See prescribing information for complete instructions for setting up bag for administration

Rectal Administration

For rectal administration only

Prepare patient for administration by requesting they empty their bladder and bowel, if possible

Position patient in left-side position or knee-chest position for rectal administration

Apply water-soluble lubricant to administration tube tip; gently insert administration tube tip into rectum ~12 cm (5 inches) in a direction pointed slightly toward the umbilicus

Hold administration tube in place with 1 hand for the entire procedure to maintain the tube position in the rectum; with the other hand, open the pinch clamp on administration tube, and then gradually raise the bag to allow delivery via gravity flow

Do not allow administration tube to sag or loop, as this will prevent the entire dose from being delivered

Do not squeeze the bag as this may cause patient discomfort

Do not hang bag from IV stand

When entire dose has been delivered, close pinch clamp and then slowly withdraw the tube; take care to prevent any residual suspension remaining in tube from leaking out (some suspension will remain in tube after administration)

Once entire dose has been delivered, keep patient in position for up to 15 minutes to minimize any cramping that may occur

Dispose of all components for administration in medical waste

Storage

Contains live microorganisms; follow storage requirements carefully

Unopened carton

• Store in ultracold freezer (-60ºC to -90ºC [-76ºF to -130ºF)
• Alternatively, store refrigerated at 2-8ºC (36-46ºF) for up to 5 days (including thaw time)
• Do not refreeze after thawing

Administration set

• Store at 10-34ºC (50-93ºF)
• DO NOT store administration set in the freezer