Drug information of bezlotoxumab

Bezlotoxumab is a human IgG1 monoclonal antibody which binds to C. difficile toxin B and neutralizes it to prevent its toxic effects; bezlotoxumab does not bind to C. difficile toxin A

Metabolism
Metabolized via catabolism
Half life
19
 days
Excretion
Eliminated primarily through catabolism

Clostridioides (formerly Clostridium) difficile infection, adjunctive therapy: To reduce recurrence of Clostridioides (formerly Clostridium) difficile infection (CDI) in patients ≥18 years of age who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI recurrence

Usual Adult Dose for Clostridial Infection: 10 mg/kg IV over 60 minutes as a single dose

Hypersensitivity to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 18 years

>10%
Cardiovascular: Cardiac failure
1%
 to 10%
Cardiovascular: Cardiac failure
Central nervous system: Headache
Gastrointestinal: Nausea
Miscellaneous: Infusion related reaction (10%; including nausea, fatigue, fever, dizziness, headache, dyspnea, and hypertension), fever
<1%
postmarketing, and/or case reports: Ventricular tachyarrhythmia

There are no known significant interactions

This drug is not indicated for the treatment of CDI; it is not an antibacterial drug and should only be used in conjunction with antibacterial drug treatment of CDI

The safety and efficacy of repeat administration of this drug in patients with CDI have not been studied

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

Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect
Severe headache
Dizziness
Passing out
Vision changes
Heart problems like cough or shortness of breath that is new or worse, swelling of the ankles or legs, abnormal heartbeat, weight gain of more than five pounds in 24 hours, dizziness, or passing out
Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat

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

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

The safety and efficacy of repeat administration of this drug in patients with CDI have not been studied

Administer the diluted solution as an IV infusion over 60 minutes using a sterile, nonpyrogenic, low-protein binding 0.2 to 5 micron in-line or add-on filter

The diluted solution can be infused via a central line or peripheral catheter

Do not administer this drug as an IV push or bolus

Do not coadminister other drugs simultaneously through the same infusion line

The product does not contain a preservative. The diluted solution may be stored either at room temperature for up to 16 hours or under refrigeration at 2C to 8C for up to 24 hours; if refrigerated, allow the IV bag to come to room temperature prior to use.
Do not freeze the diluted solution

The contents of the vial are compatible with either 0.9% sodium chloride injection or 5% dextrose injection

Adequate and well-controlled studies of bezlotoxumab have not been conducted in pregnant women
No animal reproductive and developmental studies have been conducted