fecal microbiota, live-jslm 150 mL rectal suspension enema

Generic name:
Fecal microbiota suspension (live) - rectal

Brand name(s)
Rebyota

This product is used to help prevent another return of a certain infection (C. difficile-CDI) in the intestines after completing antibiotics for a return of the infection. This product is made from human stool from screened donors. It is thought to work by giving healthy bacteria to you. Treatment can decrease symptoms of CDI such as diarrhea, nausea, loss of appetite, and stomach tenderness or pain.

This product is not used for treatment of CDI.

This product is given into the rectum by a health care professional.

For best results, use after emptying your bladder and bowel, if possible. Lie on your left side with the left knee bent toward the chest. Another position that can be used is to kneel, then lower your head and chest forward until the left side of your face is resting on a surface and your left arm is folded comfortably. A health care professional will give this product into your rectum. After receiving this product, stay in your position for up to 15 minutes to decrease cramping that may occur. However, you may use the restroom if needed.

Do not take any antibiotics by mouth for up to 8 weeks after receiving this treatment unless directed by your doctor.

Tell your doctor if your diarrhea does not get better or if it gets worse (if you get 3 or more loose bowel movements within a 24-hour period for 2 days in a row).

Abdominal pain, diarrhea, bloating, gas, or nausea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this product has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this product, tell your doctor or pharmacist if you have any allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This product is safe to use during pregnancy when used as directed.

It is unknown if this drug passes into breast milk. However, it is unlikely to pass into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This product may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as stool tests) may be done while you are using this medication. Keep all medical and lab appointments.

Not applicable.

Not applicable. This type of product is given in a hospital or clinic or doctor's office and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.