bezlotoxumab

Action and Spectrum

Actions and Spectrum:

bezlotoxumab is a monoclonal antibody used to prevent recurrent Clostridioides difficile infection in adults at high risk for recurrence. It binds to C. difficile toxin B, reducing the risk of recurrent infection. bezlotoxumab is a passive immunization therapy and does not directly kill C. difficile bacteria.

Drug Interaction

Adverse Reaction

Frequency Defined

10%:

Heart failure (12.7%)

1-10%:

Infusion-related reactions (10%)

Nausea (7%)

Heart failure, no history of CHF (2.3%)

Pyrexia (5%)

Headache (4%)

Black Box Warning

Contraindication / Caution

Contraindication

bezlotoxumab should not be used to treat an active Clostridioides difficile infection, as it is ineffective in treating an ongoing infection.

There is limited data on the safety and efficacy of bezlotoxumab in pregnant and breastfeeding women.

Bezlotoxumab may interfere with laboratory tests that detect C. difficile toxins, so clinicians should be aware of this when interpreting test results.

There have been rare reports of infusion reactions and anaphylaxis with bezlotoxumab, so patients should be monitored closely during and after the infusion.

Comorbidities:

Some of the comorbidities that may increase the risk of recurrent C. difficile infection and may benefit from bezlotoxumab include:

• Advanced age
• Immunosuppression
• Inflammatory bowel disease (IBD)
• Chronic kidney disease
• Gastrointestinal surgery
• Recent antibiotic use
• Cancer chemotherapy
• Liver disease
• Diabetes mellitus

Pregnancy / Lactation

Pregnancy consideration:

The drug is not recognized during pregnancy.

Breastfeeding warnings:

No data is available regarding the excretion of the drug in breast milk.

Pregnancy category:

Category A: well-controlled and satisfactory studies do not show risk to the fetus in the first/later trimester.

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.

Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.

Category N: No data is available for the drug under this category.

Pharmacology

Pharmacology:

bezlotoxumab is a human monoclonal antibody that binds to C. difficile toxin B, one of the two main toxins produced by Clostridioides difficile bacteria. bezlotoxumab neutralizes its harmful effects, such as damage to the colon lining and inflammation, thereby reducing the risk of recurrent C. difficile infection.

Pharmacodynamics:

The pharmacodynamics of bezlotoxumab involves its binding to C. difficile toxin B, one of the two main toxins produced by Clostridioides difficile bacteria. By binding to the toxin, bezlotoxumab neutralizes its harmful effects, such as damage to the colon lining and inflammation, thereby reducing the risk of recurrent C. difficile infection.

Pharmacokinetics:

The pharmacokinetics of bezlotoxumab are as follows

Absorption

The AUC is 53 mg·h/mL

The value of Cmax 185 mcg/mL

Distribution

The volume of distribution is 7.33 L

Metabolism

The drug is catabolized, and no drug interactions are expected

Elimination

The half-life of the drug is 19 days

The rate of clearance is 0.317 L/day. It increases with the body weight

Adminstartion

Administration:

bezlotoxumab is used to prevent recurrent Clostridioides difficile infection (CDI) in adults at high risk for recurrence. CDI is a type of bacterial infection that affects the gut and is most associated with recent antibiotic use.

CDI can cause various symptoms, from mild diarrhea to severe inflammation of the colon and life-threatening complications. Patients with CDI are at risk of recurrence, which can be challenging to treat and can lead to significant morbidity and healthcare costs.

Patient Information Leaflet

Patient information leaflet

Generic Name: bezlotoxumab

Pronounced: BEZ-loe-TOX-ue-mab

Why do we use bezlotoxumab?

bezlotoxumab is used to prevent recurrent Clostridioides Difficile Infection (CDI) in adults who are at high risk for recurrence. CDI is a type of bacterial infection that affects the gut, and it is most associated with recent antibiotic use.

CDI can cause a range of symptoms, from mild diarrhea to severe inflammation of the colon and life-threatening complications. Patients with CDI are at risk of recurrence, which can be challenging to treat and can lead to significant morbidity and healthcare costs.