Patient Medication Information: uses, side effects, how to take - Rebyota
What REBYOTA is used for:
- REBYOTA is used 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 not indicated for the treatment of CDI.
How REBYOTA works:
It is believed that REBYOTA is involved in the repopulation and restoration of the composition and diversity of the gut microbiome to suppress C. difficile outgrowth and CDI recurrence.
The ingredients in REBYOTA are:
Medicinal ingredients: Fecal microbiota
Non-medicinal ingredients: Excipient solution of PEG/Saline (Less than 6 grams of Polyethylene Glycol 3350 PEG), 0.9% Sodium Chloride Irrigation (Saline))
REBYOTA comes in the following dosage forms:
Suspension. A single dose is 150 mL.
Do not use REBYOTA if:
- Fecal microbiota, live, is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
- The fecal microbiota, live, are mixed into a solution containing polyethylene glycol 3350 (PEG 3350) and saline (0.9% sodium chloride). PEG 3350 can sometimes cause irritation in the digestive system. Saline might not be safe for people who need to limit sodium, such as those with heart failure or kidney problems.
- 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.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take REBYOTA. Talk about any health conditions or problems you may have, including if you:
- 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.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with REBYOTA:
- Since REBYOTA is not absorbed into the body, no metabolic drug-drug interactions are expected.
How to take REBYOTA:
- REBYOTA will be given to you by a healthcare professional.
- For administration of REBYOTA follow the instruction for use provided with the REBYOTA Administration Set.
Usual dose:
Rectal suspension of 150 mL
Overdose:
There is no clinical experience with overdosage of REBYOTA. Up to two doses have been administered within 7 days in a REBYOTA clinical program.
| If you think you, or a person you are caring for, have taken too much REBYOTA, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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Missed Dose:
Not applicable.
Possible side effects from using REBYOTA:
These are not all the possible side effects you may have when taking REBYOTA. If you experience any side effects not listed here, tell your healthcare professional.
The most common adverse reactions following treatment with REBYOTA (reported by ≥3% of all subjects and greater than placebo) were abdominal pain, diarrhea, abdominal distension, flatulence and nausea.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Upon Receipt:
REBYOTA carton can be stored either in an ultracold freezer at -60° to -90°C (-76° to -130°F) until its expiration or stored in the refrigerator at 2° to 8°C (36° to 46°F) for up to 5 days (including the 24 hour thawing period).
Before Using:
Prior to use, thaw REBYOTA completely by placing carton in a refrigerator (2˚C to 8˚C, 36˚F to 46˚F) for approximately 24 hours.
DO NOT thaw at room temperature or using a heat source such as a microwave or hot water.
Do not refreeze REBYOTA after thawing.
For storage condition of the REBYOTA Administration Set follow the instruction for use provided with the REBYOTA Administration Set.
Dispose of all components in medical waste.
Keep out of reach and sight of children.
If you want more information about REBYOTA:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website (www.ferring.ca/en/products/), or by calling 1-866-384-1314.
Last Revised March 5, 2025
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