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Zinplava Generic Name & Formulations
Legal Class
Rx
General Description
Bezlotoxumab 25mg/mL; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Human IgG1 monoclonal antibody.
How Supplied
Single-dose vial (40mL)—1
Manufacturer
Generic Availability
NO
Mechanism of Action
Bezlotoxumab, a human monoclonal antibody, inhibits the binding of toxin B and prevents its effects on mammalian cells. Bezlotoxumab does not bind to C. difficile toxin A.
Zinplava Indications
Indications
To reduce recurrence of Clostridioides difficile infection (CDI) in patients who are receiving antibacterial drug treatment of CDI and are at high risk for CDI recurrence.
Limitations of Use
Not for treating CDI. Use only in conjunction with antibacterial drug treatment of CDI.
Zinplava Dosage and Administration
Adults and Children
<1yr: not established. Infuse over 60mins. ≥1yr: a single dose of 10mg/kg.
Zinplava Contraindications
Not Applicable
Zinplava Boxed Warnings
Not Applicable
Zinplava Warnings/Precautions
Warnings/Precautions
History of CHF. Pregnancy. Nursing mothers.
Zinplava Pharmacokinetics
Distribution
-
Mean volume of distribution: 7.33 L.
Elimination
-
Half-life: ~19 days. Geometric mean clearance: 0.317 L/day.
Zinplava Interactions
Not Applicable
Zinplava Adverse Reactions
Adverse Reactions
Nausea, pyrexia, headache, infusion-related reactions; heart failure.
Zinplava Clinical Trials
See Literature
Zinplava Note
Not Applicable
Zinplava Patient Counseling
See Literature
