Reduction in recurrence of Clostridioides difficile infection (CDI) in patients who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI recurrence.
Action⬆⬇
Binds to Clostridioides difficile toxin B and neutralizes its effects.
Therapeutic effects:
Reduced CDI recurrence.
Pharmacokinetics⬆⬇
Absorption: IV administration results in complete bioavailability.
Distribution: Minimally distributed to tissues.
Metabolism/Excretion: Eliminated primarily through catabolism.
Half-Life: 19 days.
Time/Action Profile⬆⬇
(plasma concentrations)
ROUTE
ONSET
PEAK
DURATION
IV
unknown
unknown
unknown
Contraind./Precautions⬆⬇
Contraindicated in:
None.
Use Cautiously in:
HF;
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Children <1 yr (safety and effectiveness not established).
IV (Adults and Children ≥1 yr): 10 mg/kg as a single dose.
Availability⬆⬇
Solution for injection: 25 mg/mL
Assessment⬆⬇
Assess for signs and symptoms of CDI prior to and following therapy.
Implementation⬆⬇
Not for treatment of CDI; must be used with antibacterial agents.
IV Administration:
Intermittent Infusion: Diluent: Withdraw volume from bezlotoxumab vial based on patient weight and transfer to IV bag of 0.9% NaCl or D5W. Invert gently to mix; do not shake. Solution is clear to moderately opalescent, colorless to pale yellow; do not administer solutions that are discolored or contain particulate matter. Concentration: 1 mg/mL to 10 mg/mL. Store in refrigerator for up to 24 hrs or at room temperature protected from light for up to 16 hrs prior to preparation; do not freeze.
Rate: Infuse over 60 min using a sterile, non-pyrogenic, low-protein binding 0.205 micron in-line or add-on filter. Do not administer as IV push or bolus. May be infused via central line or peripheral catheter.
Y-Site Incompatibility: Do not administer other drugs simultaneously through same infusion line.
Patient/Family Teaching⬆⬇
Inform patient that bezlotoxumab does not replace antibacterial treatment for their CDI infection. Antibacterial medications must be continued as directed.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Evaluation/Desired Outcomes⬆⬇
Decrease in recurrence of CDI.
US Brand Names⬆⬇
Zinplava
Code⬆
NDC Code
0006- Merck Sharp & Dohme LLC
0006-3025- ZINPLAVA
0006-3025-00- 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-3025-00) / 40 mL in 1 VIAL, SINGLE-DOSE (0006-3025-01)
