Introduction

Fecal microbiota, live-jslm is a fecal microbiota suspension.

Uses for Fecal microbiota, live

Fecal microbiota, live-jslm has the following uses:

Fecal microbiota, live-jslm 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. Fecal microbiota, live-jslm is not indicated for the treatment of CDI.

The Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA) has published guidelines on the management of CDI. The guidelines state that fecal microbiota transplantation (FMT) is recommended only for patients with multiple recurrences of CDI who have failed appropriate antibiotic treatments and where appropriate screening of donor and donor fecal specimens has been performed.

Fecal microbiota, live Dosage and Administration

General

Fecal microbiota, live-jslm is available in the following dosage form(s) and strength(s):

Suspension: 150 mL of fecal microbiota suspension which contains between 1×10⁸ and 5×10¹⁰ colony forming units (CFU) per mL of fecal microbes including >1×10⁵ CFU/mL of Bacteroides.

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration in Adults ≥18 Years of Age

• For rectal administration only.

• Prior to use, thaw fecal microbiota, live-jslm completely by placing the carton in a refrigerator, 2°C to 8°C (36°F to 46°F), for approximately 24 hours. The 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.

• Administer fecal microbiota, live-jslm 24 to 72 hours after the last dose of antibiotics for CDI.

• Administer a single dose of 150 mL rectally.

• Consult the full prescribing information for additional information on preparation and administration of fecal microbiota, live-jslm.

Contraindications

• Severe allergic reactions (e.g. anaphylaxis) to any component of fecal microbiota, live-jslm.

Warnings/Precautions

Transmissible Infectious Agents

Because fecal microbiota, live-jslm 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 the manufacturer.

Management of Acute Allergic Reactions

Appropriate medical treatment must be immediately available in the event an acute anaphylactic reaction occurs following administration of fecal microbiota, live-jslm.

Potential Presence of Food Allergens

Fecal microbiota, live-jslm is manufactured from human fecal matter and may contain food allergens. The potential for fecal microbiota, live-jslm to cause adverse reactions due to food allergens is unknown.

Specific Populations

Pregnancy

Fecal microbiota, live-jslm is not absorbed systemically following rectal administration, and maternal use is not expected to result in fetal exposure to the drug.

Lactation

Fecal microbiota, live-jslm is not absorbed systemically by the mother following rectal administration, and breastfeeding is not expected to result in exposure of the child to fecal microbiota, live-jslm.

Pediatric Use

Safety and effectiveness of fecal microbiota, live-jslm in individuals younger than 18 years of age have not been established.

Geriatric Use

Of the 978 adults who received fecal microbiota, live-jslm, 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 fecal microbiota, live-jslm are not sufficient to determine if adults 65 years of age and older respond differently than younger adults.

Common Adverse Effects

The most commonly reported (≥3%) adverse reactions occurring in adults following a single dose of fecal microbiota, live-jslm were abdominal pain, (8.9%), diarrhea (7.2%), abdominal distention (3.9%), flatulence (3.3%), and nausea (3.3%).

General

Fecal microbiota, live-jslm is available in the following dosage form(s) and strength(s):

Suspension: 150 mL of fecal microbiota suspension which contains between 1×10⁸ and 5×10¹⁰ colony forming units (CFU) per mL of fecal microbes including >1×10⁵ CFU/mL of Bacteroides.

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration in Adults ≥18 Years of Age

• For rectal administration only.

• Prior to use, thaw fecal microbiota, live-jslm completely by placing the carton in a refrigerator, 2°C to 8°C (36°F to 46°F), for approximately 24 hours. The 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.

• Administer fecal microbiota, live-jslm 24 to 72 hours after the last dose of antibiotics for CDI.

• Administer a single dose of 150 mL rectally.

• Consult the full prescribing information for additional information on preparation and administration of fecal microbiota, live-jslm.