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.