Donor Human Stool
Generic Name: donor human stool
Brand Names:
Rebyota
11 DESCRIPTION REBYOTA (fecal microbiota, live – jslm) is an opaque fecal microbiota suspension for rectal administration. REBYOTA is manufactured from human fecal matter sourced from qualified donors. The human fecal matter is tested for a panel of transmissible pathogens. Donors do not have dietary restrictions with respect to potential food allergens.
Overview
11 DESCRIPTION REBYOTA (fecal microbiota, live – jslm) is an opaque fecal microbiota suspension for rectal administration. REBYOTA is manufactured from human fecal matter sourced from qualified donors. The human fecal matter is tested for a panel of transmissible pathogens. Donors do not have dietary restrictions with respect to potential food allergens.
Uses
1 INDICATIONS AND USAGE 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. 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. ( 1 ) Limitation of Use: REBYOTA is not indicated for treatment of CDI. Limitation of Use: REBYOTA is not indicated for treatment of CDI.
Dosage
2 DOSAGE AND ADMINISTRATION For rectal administration only. For rectal administration only. Administer REBYOTA 24 to 72 hours after the last dose of antibiotics for CDI. ( 2 ) Administer a single dose of 150 mL rectally of REBYOTA. ( 2 ) 2.1 Dose A single dose is 150 mL. 2.2 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.
Side Effects
6 ADVERSE REACTIONS The most commonly reported (≥ 3%) adverse reactions occurring in adults following a single dose of REBYOTA were abdominal pain, (8.9%), diarrhea (7.2%), abdominal distention (3.9%), flatulence (3.3%), and nausea (3.3%). The most commonly reported (≥ 3%) adverse reactions occurring in adults following a single dose of REBYOTA were abdominal pain, (8.9%), diarrhea (7.2%), abdominal distention (3.9%), flatulence (3.3%), and nausea (3.3%) ( Table 1 ). To report SUSPECTED ADVERSE REACTIONS, contact Ferring Pharmaceuticals Inc. at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Warnings
5 WARNINGS AND PRECAUTIONS 5.1 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. 5.2 Management of acute allergic reactions Appropriate medical treatment must be immediately available in the event an acute anaphylactic reaction occurs following administration of REBYOTA. 5.3 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. 4 CONTRAINDICATIONS 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 ] . Severe allergic reactions (e.g. anaphylaxis) to any component of REBYOTA. ( 4 )
Pregnancy
8.1 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.
Storage
16.2 Storage and Handling REBYOTA contains live microorganisms. It is important to follow the storage requirements. Upon Receipt : Store the REBYOTA carton in an ultracold freezer (-60°C to -90°C, -76°F to -130°F). Alternatively, store in a refrigerator (2°C to 8°C, 36°F to 46°F) for up to 5 days (including thaw time). Do not refreeze REBYOTA after thawing.
Frequently Asked Questions
What is Donor Human Stool used for?▼
1 INDICATIONS AND USAGE 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. 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. ( 1 ) Limitation of Use: REBYOTA is not indicated for treatment of CDI. Limitation of Use: REBYOTA is not indicated for treatment of CDI.
What are the side effects of Donor Human Stool?▼
6 ADVERSE REACTIONS The most commonly reported (≥ 3%) adverse reactions occurring in adults following a single dose of REBYOTA were abdominal pain, (8.9%), diarrhea (7.2%), abdominal distention (3.9%), flatulence (3.3%), and nausea (3.3%). The most commonly reported (≥ 3%) adverse reactions occurring in adults following a single dose of REBYOTA were abdominal pain, (8.9%), diarrhea (7.2%), abdominal distention (3.9%), flatulence (3.3%), and nausea (3.3%) ( Table 1 ). To report SUSPECTED ADVERSE REACTIONS, contact Ferring Pharmaceuticals Inc. at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Can I take Donor Human Stool during pregnancy?▼
8.1 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.
What are the important warnings for Donor Human Stool?▼
5 WARNINGS AND PRECAUTIONS 5.1 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. 5.2 Management of acute allergic reactions Appropriate medical treatment must be immediately available in the event an acute anaphylactic reaction occurs following administration of REBYOTA. 5.3 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. 4 CONTRAINDICATIONS 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 ] . Severe allergic reactions (e.g. anaphylaxis) to any component of REBYOTA. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.