Microbiota Rectal

Microbiota Rectal is a prescription medication used to prevent the recurrence of Clostridioides difficile infection.

• Microbiota Rectal is available under the following different brand names: Rebyota, rectal microbiota live-jslm

Common side effects of Microbiota Rectal include:

• abdominal pain,
• diarrhea,
• abdominal distention,
• gas (flatulence), and
• nausea.

Serious side effects of Microbiota Rectal include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,

Rare side effects of Microbiota Rectal include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Rectal suspension

• Each 150mL dose contains between 1x108 and 5x1010 colony-forming units (CFU) per mL of fecal microbes, including more than 1x105 CFU/mL of Bacteroides
• Fecal matter suspended in polyethylene glycol (PEG) 3350 and 0.9% NaCl solution

Clostridioides difficile Infection

Adult dosage

• 150 mL rectally as a single dose

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Microbiota Rectal has no noted severe interactions with any other drugs.
• Microbiota Rectal has no noted serious interactions with any other drugs.
• Microbiota Rectal has no noted moderate interactions with any other drugs.
• Microbiota Rectal has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• History of a severe allergic reaction (eg, anaphylaxis) to any of the known product components

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Microbiota Rectal?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Microbiota Rectal?”

Cautions

• Patients should notify the physician if persistent diarrhea, defined as 3 or more loose bowel movements within a 24-hr period for 2 consecutive days, returns following product administration
• Instruct patients not to take any oral antibiotic therapy for up to 8 weeks after product administration unless directed by their physician
• Transmissible infectious agents
  • Suspension may carry the risk of transmitting infection since it is manufactured from human fecal matter
  • 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
• Acute allergic reaction
  • Administer in a facility where appropriate medical treatment is immediately available in event of an acute anaphylactic reaction
• Food allergens
  • Manufactured from human fecal matter and may contain food allergens
  • The potential for microbiota to cause adverse reactions due to food allergens is unknown

Pregnancy and Lactation

• Not absorbed systemically following rectal administration, and maternal use is not expected to result in fetal exposure
• Lactation
  • Not absorbed systemically by the mother following rectal administration, and breastfeeding is not expected to result in the exposure of the child