Bezlotoxumab (Zinplava)
Antitoxin | Immunological Agent
Bezlotoxumab, a monoclonal antibody targeting Clostridioides difficile toxin B, has been approved by the FDA to reduce the recurrence of C. difficile infection (CDI) in patients 18 years and older who are receiving antibacterial drug treatment for CDI and are at risk for recurrence.
Indication and Efficacy:
Bezlotoxumab is indicated to prevent the recurrence of CDI in adults who are at high risk for recurrence. It is not for treating active infection but is used in conjunction with standard antibiotic treatment for CDI. Clinical trials have shown that Bezlotoxumab significantly reduces the risk of recurrent infections compared to placebo.
Dosage and Administration:
The recommended dose of Bezlotoxumab is a single 10 mg/kg dose, administered via intravenous infusion over 60 minutes. It is important to monitor the infusion site for any reactions and to administer the drug slowly to minimize the risk of infusion-related reactions.
Risk Factors for Recurrence:
Patients considered at high risk for CDI recurrence include those with a history of multiple CDI episodes, individuals aged 65 years and older, those with severe CDI, or patients with an immunocompromised status. Identifying these patients is crucial for determining the appropriateness of Bezlotoxumab therapy.
Safety and Adverse Effects:
Common adverse reactions include nausea, pyrexia, and headache. Serious adverse reactions are rare but can include heart failure and hypersensitivity reactions. It is essential to review a patient's medical history for heart failure before administering Bezlotoxumab.
Monitoring and Follow-Up:
After administration of Bezlotoxumab, patients should be monitored for signs of adverse reactions during and after the infusion. Follow-up is important to assess the effectiveness of the treatment in preventing CDI recurrence and to manage any potential side effects.
Patient Education:
Educate patients about the purpose of Bezlotoxumab as a preventive treatment rather than a cure for active CDI. Inform them about the potential side effects and the importance of completing their course of antibiotics for CDI.
Combination with Antibiotics:
Bezlotoxumab should be used in conjunction with standard-of-care antibiotic treatment for CDI. It is not a substitute for antibiotic therapy but an adjunct to reduce the risk of recurrence.
Storage and Handling:
Bezlotoxumab requires refrigeration and should be protected from light. It should be allowed to reach room temperature naturally before administration. Do not shake or freeze the product.
Clinical Judgment:
Despite the evidence supporting its use, the decision to administer Bezlotoxumab should be based on individual patient risk factors, potential benefits, and clinical judgment. Consideration of the patient's overall clinical picture is paramount.
https://www.merck.com/product/usa/pi_circulars/z/zinplava/zinplava_pi.pdf —
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