Bezlotoxumab

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.

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

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 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.

Antitoxin; fully human IgG1 monoclonal antibody that binds to and neutralizes Clostridium difficile toxin B.1 2 8 11 14

Distribution

Extent

Mean volume of distribution is 7.33 L following IV infusion.1

Systemically administered bezlotoxumab may be translocated to gut lumen via nonspecific paracellular transport facilitated by C. difficile toxin-induced disruption of intestinal epithelium integrity.13

Not known whether distributed into milk.1

Plasma Protein Binding

Not expected.1

Elimination

Metabolism

Undergoes protein catabolism;1 degraded into small peptides and individual amino acids.4

Elimination Route

Not excreted by renal elimination.4

Has been detected in feces.4

Half-life

Approximately 19 days.1

Special Populations

Clearance increases with increasing body weight.1

Pharmacokinetics not substantially affected by renal or hepatic impairment, age ≥65 years, gender, ethnicity, or comorbid conditions.1

• It is used to lower the chance of a type of bacterial infection called Clostridium difficile (C diff) from coming back.

(bez loe TOX ue mab)

Concerns related to adverse effects:

• Heart failure: Heart failure has been reported at a higher rate in patients treated with bezlotoxumab (compared to placebo), primarily occurring in patients with underlying heart failure. Additionally, a higher mortality rate due to cardiac failure, infection, and respiratory failure was observed in patients with a history of heart failure who received bezlotoxumab (compared to those who received placebo). In patients with a history of heart failure, bezlotoxumab use should be reserved for situations when the benefits outweigh risks.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

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.

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

• congestive heart failure.

It is not known whether this medicine 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.

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

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.

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.

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

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

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

Safety has not been established during pregnancy. US FDA pregnancy category: Not assigned Risk Summary: No animal studies have been conducted. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.