Medically reviewed by Drugs.com. Last updated on Aug 3, 2019.
(bez loe TOX ue mab)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Zinplava: 1000 mg/40 mL (40 mL) [contains polysorbate 80]
Brand Names: U.S.
- Monoclonal Antibody
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.
Metabolized via catabolism
Eliminated primarily through catabolism
Use: Labeled Indications
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
Limitations of use: Bezlotoxumab is not indicated for the treatment of CDI. Bezlotoxumab is not an antibacterial drug and should only be used in conjunction with antibacterial drug treatment of CDI.
There are no contraindications listed in the manufacturer's labeling.
Clostridioides (formerly Clostridium) difficile infection, adjunctive therapy: IV: 10 mg/kg as a single dose during antibacterial treatment for Clostridioides (formerly Clostridium) difficile infection. Repeat doses have not been studied.
Refer to adult dosing.
Must be diluted prior to infusion. Immediately after removing vial from refrigerator, withdraw appropriate volume from vial and transfer to infusion bag of either normal saline or D5W to a final concentration between 1 to 10 mg/mL. Do not use vials if solution is discolored or if particulates are visible. Gently invert to mix; do not shake.
IV: Infuse IV over 60 minutes through a sterile, nonpyrogenic, low-protein binding 0.2 to 5 micron in-line or add-on filter. Do not administer as an IV push or bolus. May be infused via a central line or peripheral catheter. Do not coadminister other drugs simultaneously through the same infusion line. If infusion solution was refrigerated, allow to come to room temperature prior to administration. Infusion should be completed within 16 hours of preparation (if stored at room temperature) or within 24 hour (if refrigerated).
Store intact vials at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Do not shake vials. Solutions diluted for infusion may be stored either at room temperature for up to 16 hours or refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours. Infusion must be completed within these time frames. If refrigerated, allow the intravenous bag to come to room temperature prior to use. Do not freeze diluted solution.
There are no known significant interactions.
>10%: Cardiovascular: Cardiac failure (exacerbation:13%)
1% to 10%:
Cardiovascular: Cardiac failure (2%)
Central nervous system: Headache (4%)
Gastrointestinal: Nausea (7%)
Miscellaneous: Infusion related reaction (10%; including nausea, fatigue, fever, dizziness, headache, dyspnea, and hypertension), fever (5%)
<1%, postmarketing, and/or case reports: Ventricular tachyarrhythmia
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 humanized monoclonal antibody (IgG1). Potential placental transfer of human IgG is dependent upon the IgG subclass and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience nausea or loss of strength and energy. Have patient report immediately to prescriber severe headache, dizziness, passing out, vision changes, or signs of heart problems (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) (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
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More about bezlotoxumab
Other brands: Zinplava