Version May 2024
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]) (Ref).
IV: 10 mg/kg as a single dose during antibacterial treatment for CDI (Ref). Repeat doses have not been studied (Ref).
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.
(For additional information see "Bezlotoxumab: Pediatric drug information")
There are no dosage adjustments provided in the manufacturer's labeling. In a pharmacokinetic study of adults, 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. In a pharmacokinetic study of adults, no clinically meaningful differences in exposure between patients with hepatic impairment and normal hepatic function were noted.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.
>10%: Cardiovascular: Heart failure (2%; worsening of heart failure:13%)
1% to 10%:
Gastrointestinal: Nausea (7%)
Hypersensitivity: Infusion-related reaction (10%)
Nervous system: Headache (4%)
Miscellaneous: Fever (5%)
<1%: Cardiovascular: Ventricular tachyarrhythmia
Postmarketing: Gastrointestinal: Vomiting (Wilcox 2017)
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.
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
Solution (Zinplava Intravenous)
1000 mg/40 mL (per mL): $114.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
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).
IV: If diluted solution was refrigerated, allow to come to room temperature prior to administration. Administer by IV infusion; do not administer as an IV push or bolus. Infuse over 60 minutes through a sterile, nonpyrogenic, low-protein binding 0.2 to 5 micron in-line or add-on filter. May administer via a central or peripheral catheter. Do not coadminister other drugs simultaneously through the same infusion line.
Clostridioides difficile infection, secondary prevention: To reduce recurrence of C. difficile infection (CDI) in adults and pediatric patients ≥1 year 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.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Rozanolixizumab: 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.
Note: Pharmacokinetics in pediatric patients ≥1 year of age are similar to those observed in adults.
Distribution: 7.33 L
Metabolism: Metabolized via catabolism
Half-life elimination: ~19 days
Excretion: Eliminated primarily through catabolism
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