Fecal microbiota, live-jslm (Rectal)

Fecal microbiota, live-jslm is used to prevent Clostridioides difficile infection (CDI) from returning in patients who have received antibiotic treatment. C. diff is a type of bacteria that causes severe diarrhea.

This medicine should only be given by or under the close supervision of your doctor.

It is very important that your doctor check your progress at regular visits to ensure that this medicine is working properly and to check for unwanted effects.

This medicine is made from donated human feces and may contain food allergens. It may also carry a risk of transmitting certain infections. Talk with your doctor about this risk if you are concerned.

This medicine may cause serious allergic reactions, including anaphylaxis. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine compared to the benefits it will provide. For this medicine, think about the following:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been enough studies to determine how Rebyota™ affects children. Safety and effectiveness have not been established for this age group.

Geriatric

Current studies have not shown any specific issues for older adults that would limit the use of Rebyota™ in the elderly.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines can be used together even if there may be an interaction. In these situations, your doctor may need to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Diarrhea
• Stomach pain

Less common

• Full or bloated feeling
• Pressure in the stomach
• Swelling of the stomach area

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also tell you ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Less common

• Excess air or gas in the stomach or intestines
• Nausea
• Passing gas

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Rebyota

Available Dosage Forms:

• Suspension

Therapeutic Class: Colorectal Agent

A doctor or other trained health professional will give you this medicine in a hospital. It is given through your rectum. This medicine is given 24 to 72 hours after the last dose of antibiotic.

Do not take an antibiotic medicine for up to 8 weeks after receiving this medicine.