Microbiota Oral

Microbiota Oral is used to prevent the recurrence of Clostridioides difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI).

• Microbiota Oral is available under the following different brand names: Vowst, fecal microbiota spores, live-brpk.

Common side effects of Microbiota Oral include:

• Abdominal pain,
• Diarrhea,
• Abdominal distention,
• Gas (flatulence), and
• Nausea.

Serious side effects of Microbiota Oral include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat

Rare side effects of Microbiota Oral 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, coordination loss, 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

Capsule

• 1x106 – 3x107 Firmicutes spore colony forming units/capsule.

Clostridioides difficile Infection

Adult dosage

• 4 capsules oral once a day for 3 consecutive days

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 Oral has severe interactions with no other drugs.
• Microbiota Oral has serious interactions with at least 103 other drugs.
• Microbiota Oral has moderate interactions with no other drugs.
• Microbiota Oral has minor interactions with no 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 the products you use. 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 health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Transmissible infectious agents
• May carry the risk of transmitting infectious agents.
• Healthcare providers should report any suspected infection transmitted by this product to Aimmune Therapeutics, Inc at 1-833-246-2566
• The potential presence of food allergens
• Manufactured from human fecal matter and may contain food allergens.
• The potential for Microbiota Oral to cause adverse reactions due to food allergens is unknown.
• Drug interaction overview
  • Antibiotics
  • Avoid coadministration.
  • Microbiota Oral contains bacterial spores; antibacterial may decrease efficacy if coadministered.
  • Complete antibiotic regimens 2-4 days before initiating Microbiota Oral.

Pregnancy and Lactation

• There are no data on use in pregnant females.
• Developmental toxicity studies in animals have not been conducted.
• Lactation
  • Unknown if excreted in human milk.
  • Data are not available to assess the effects on breastfed infants or on milk production or excretion.