Clostridioides difficile infection, secondary prevention:
Note: For patients with a history of C. difficile infection (CDI) within the past 6 months; may additionally consider for patients with an initial episode at high risk for recurrence (≥65 years of age, immunocompromised host, or severe CDI [ie, WBC >15,000 cells/mL or serum creatinine ≥1.5 mg/dL]) (ACG [Kelly 2021; Gerding 2018; IDSA/SHEA [Johnson 2021]).
IV: 10 mg/kg as a single dose during antibacterial treatment for CDI (IDSA/SHEA [Johnson 2021]). Repeat doses have not been studied (Wilcox 2017).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling, although in a pharmacokinetic study, no clinically meaningful differences in exposure between patients with renal impairment and normal renal function were noted.
There are no dosage adjustments provided in the manufacturer's labeling, although in a pharmacokinetic study, no clinically meaningful differences in exposure between patients with hepatic impairment and normal hepatic function were noted.
Refer to adult dosing.
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]
No
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).
Clostridioides difficile infection, secondary prevention: To reduce recurrence of C. 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.
Bezlotoxumab may be confused with basiliximab, belimumab, bevacizumab, blinatumomab, brentuximab.
Zinplava may be confused with Zinbryta.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>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
There are no contraindications listed in the manufacturer's labeling.
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.
None known.
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
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).
It is not known if bezlotoxumab is excreted in breast milk. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
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.
Distribution: 7.33 L
Metabolism: Metabolized via catabolism
Half-life elimination: ~19 days
Excretion: Eliminated primarily through catabolism
Solution (Zinplava Intravenous)
1000 mg/40 mL (per mL): $114.00
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