Bezlotoxumab is a monoclonal antibody. Monoclonal antibodies are made to target only certain cells in the body. Bezlotoxumab works by binding to a specific toxin produced by the Clostridium difficile bacteria, to help neutralize the toxin's effects.

Bezlotoxumab is used together with antibiotic medicine in adults with Clostridium difficile (C. difficile), an infection that can cause life-threatening diarrhea. Bezlotoxumab may help keep this infection from coming back after treatment.

Bezlotoxumab is not an antibiotic and will not treat the infection itself.

Bezlotoxumab may also be used for purposes not listed in this medication guide.

Before you receive bezlotoxumab, tell your doctor about all your medical conditions or allergies, and all the medicines you are using. Also make sure your doctor knows if you are pregnant or breast-feeding.

Bezlotoxumab is injected into a vein through an IV. A healthcare provider will give you this injection.

This medicine must be given slowly, and the IV infusion can take about 60 minutes to complete.

Bezlotoxumab has no antibacterial effects and will not treat the underlying infection. You must use antibiotic medication to treat C. difficile infection.

Use your antibiotic medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses of your antibiotic may also increase your risk of further infection that is resistant to antibiotics.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Usual Adult Dose for Clostridial Infection:

10 mg/kg IV over 60 minutes as a single dose

Use: To reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI recurrence

To make sure bezlotoxumab is safe for you, tell your doctor if you have:

• congestive heart failure.

It is not known whether bezlotoxumab will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether bezlotoxumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Bezlotoxumab is not approved for use by anyone younger than 18 years old.

Since bezlotoxumab is used as a single dose, it does not have a daily dosing schedule.

Since bezlotoxumab is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Bezlotoxumab may cause serious side effects. Call your doctor at once if you have:

• worsening symptoms of C. difficile infection, such as severe stomach pain or watery diarrhea;

• swelling in your hands, ankles, or feet;

• rapid weight gain; or

• shortness of breath (even with mild exertion).

Common side effects of bezlotoxumab may include:

• nausea;

• fever; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with bezlotoxumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.