Rebyota
(fecal microbiota, live-jslm)Dosage & Administration
For rectal administration only.
Administer REBYOTA 24 to 72 hours after the last dose of antibiotics for CDI.
Administer a single dose of 150 mL rectally of REBYOTA.
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Rebyota Prescribing Information
REBYOTA is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibiotic treatment for recurrent CDI.
Limitation of Use:
REBYOTA is not indicated for treatment of CDI.
For rectal administration only.
Dose
A single dose is 150 mL.
Preparation
Prior to use, thaw REBYOTA completely by placing the carton in a refrigerator, 2°C to 8°C (36°F to 46°F), for approximately 24 hours. REBYOTA carton may be stored in the refrigerator at 2°C to 8°C (36°F to 46°F) and used within 5 days, including thawing time.
DO NOT thaw using a heat source such as a microwave or hot water.
Condensation is normal after thawing.
Remove the thawed REBYOTA carton from the refrigerator. Remove the bag containing thawed REBYOTA from the outer carton and the inner carton insert. DO NOT remove the bag containing thawed REBYOTA from the sealed outer bag. Locate an Administration Set (supplied), water-soluble lubricant (not included) and a disposable underpad (not included) (See Figure 1).
- 1.
- Open the administration set and close the pinch clamp by pushing the clamp until it is fully closed (see Figure 2).
- 2.
- Remove the tab from the spike port of the bag containing thawed REBYOTA and remove the cap from the administration tube spike. Insert the administration tube spike through the spike port of the bag containing thawed REBYOTA (see Figure 3).
DO NOT remove air from the administration tube prior to insertion to avoid loss of REBYOTA.
Administration
Administer REBYOTA 24 to 72 hours after the last dose of antibiotics for CDI.
- 1.
- Prepare the patient for administration by requesting they empty their bladder and bowel, if possible. Place the patient in the left-side position or the knee-chest position with a disposable underpad beneath the patient (see Figures 4 and 5).
- 2.
- Apply water-soluble lubricant to the administration tube tip. Gently insert the administration tube tip into the rectum about 12 cm (5 inches) in a direction pointed slightly toward the navel (umbilicus) (see Figure 6).
- 3.
- Hold the administration tube in place with one hand 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 REBYOTA via gravity flow (see Figure 7 and 8).
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 REBYOTA as this could be uncomfortable for the patient.
DO NOT hang the bag from an IV stand.
- 4.
- When the entire dose has been delivered, close the pinch clamp and then slowly withdraw the tube. Take care to prevent any residual REBYOTA remaining in the tube from leaking out.
NOTE: Some REBYOTA will remain in the tube after administration.
- 5.
- 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 (see Figure 9 and 10). There are no restrictions on the patient's use of the restroom.
Dispose of all components in medical waste.
Suspension. A single dose is 150 mL.
Pregnancy
Risk Summary
REBYOTA is not absorbed systemically following rectal administration, and maternal use is not expected to result in fetal exposure to the drug.
Lactation
REBYOTA is not absorbed systemically by the mother following rectal administration, and breastfeeding is not expected to result in exposure of the child to REBYOTA.
Pediatric Use
Safety and effectiveness of REBYOTA in individuals younger than 18 years of age have not been established.
Geriatric Use
Of the 978 adults who received REBYOTA, 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 REBYOTA are not sufficient to determine if adults 65 years of age and older respond differently than younger adults.
Do not administer REBYOTA to individuals with a history of a severe allergic reaction (e.g. anaphylaxis) to any of the known product components [see Description 11].
Transmissible infectious agents
Because REBYOTA is manufactured from human fecal matter it may carry a risk of transmitting infectious agents. 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.
Management of acute allergic reactions
Appropriate medical treatment must be immediately available in the event an acute anaphylactic reaction occurs following administration of REBYOTA.
Potential presence of food allergens
REBYOTA is manufactured from human fecal matter and may contain food allergens. The potential for REBYOTA to cause adverse reactions due to food allergens is unknown.