Bezlotoxumab Injection

Bezlotoxumab injection is used to decrease the risk of Clostridium difficile infection (C. difficile or CDI; a type of bacteria that can cause severe or life-threatening diarrhea) from coming back in people who are at high risk for C. difficile infection and who are already taking an antibiotic drug to treat Clostridium difficile. Bezlotoxumab is in a class of medications called monoclonal antibodies. It works by binding to a C. difficile toxin to stop its effects on the body.

Bezlotoxumab comes as a solution (liquid) to be injected intravenously (into a vein) over 60 minutes. Bezlotoxumab is administered as a single dose by a doctor or nurse.

Bezlotoxumab injection does not take the place of antibiotic treatment for C. difficile infection; continue your antibiotic treatment as directed by your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving bezlotoxumab injection,

• tell your doctor and pharmacist if you are allergic to bezlotoxumab, any other medications, or any of the ingredients in bezlotoxumab infusion. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had heart failure.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.

Bezlotoxumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• fever

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• shortness of breath or trouble breathing
• swelling of the ankles, feet, leg, or stomach

Bezlotoxumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about bezlotoxumab injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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