Name of the Procedure:

Injection, bezlotoxumab, 10 mg
Common name(s): Zinplava injection
Technical or medical terms: Bezlotoxumab infusion, C9490

Summary

Bezlotoxumab is a medication delivered via injection to reduce the recurrence of C. difficile infection (CDI) in patients who are receiving antibiotic treatment for the infection. The drug binds to C. difficile toxin B, neutralizing its effects and helping to prevent the recurrence of the infection.

Purpose

Bezlotoxumab is used to reduce the risk of recurrent C. difficile infection (CDI), a bacterial infection that causes severe diarrhea and other intestinal conditions. The primary goal is to prevent recurrence in patients who have had CDI and are being treated with antibiotics.

Indications

• Patients with a confirmed diagnosis of C. difficile infection.
• Individuals who are receiving antibiotic treatment for CDI.
• Particularly useful for patients with a high risk of recurrence, such as those over 65 years old, with a history of CDI, or immunocompromised individuals.

Preparation

• A pre-procedure consultation with a healthcare provider.
• No specific fasting or medication adjustments required.
• Blood tests or basic health assessments to ensure suitability for treatment.

Procedure Description

1. The patient will be positioned comfortably, usually sitting or lying down.
2. An intravenous (IV) line will be inserted into a vein in the patient’s arm.
3. Bezlotoxumab will be administered through the IV over approximately 60 minutes.
4. The healthcare provider will monitor the patient for any immediate adverse reactions throughout the infusion.

Duration

• The infusion typically takes about 60 minutes.
• Total visit time may be longer to include preparation and observation.

Setting

• The procedure is usually performed in an outpatient clinic or hospital setting.

Personnel

• The procedure is administered by a registered nurse (RN) or other qualified healthcare professional.
• A healthcare provider (e.g., a physician) will oversee the treatment and be available for any complications.

Risks and Complications

• Common risks: mild infusion-related reactions such as headache, nausea, and dizziness.
• Rare risks: severe allergic reactions (anaphylaxis), infusion-related reactions requiring medical intervention.
• Complications are generally managed by stopping the infusion and providing symptomatic treatment.

Benefits

• Reduces the risk of recurrent C. difficile infection.
• Benefits may be realized within weeks following the infusion, as the risk of recurrence decreases.

Recovery

• Patients can typically return to their normal activities immediately after the infusion.
• Instructions may include watching for and reporting any delayed side effects.
• Follow-up appointments to monitor the patient’s overall health and recurrence rate.

Alternatives

• Continued antibiotic management of CDI without bezlotoxumab.
• Other adjunctive therapies or probiotics may be considered.
• Each alternative has its pros and cons, with bezlotoxumab specifically targeting toxin B to reduce recurrence while other treatments may not.

Patient Experience

• During the procedure: Mild discomfort from the IV insertion; potential for mild side effects like headache and nausea.
• After the procedure: Most patients experience little to no lingering effects; monitoring for any delayed adverse reactions.
• Pain management and comfort measures are typically not necessary, but over-the-counter medications may be used if discomfort occurs.