Zinplava

• Administer ZINPLAVA during antibacterial drug treatment for CDI. (
  2.1 Important Administration Instructions

  Administer ZINPLAVA during antibacterial drug treatment for CDI.
  )
• The recommended dose is a single dose of 10 mg/kg administered as an intravenous infusion over 60 minutes. (
  2.2 Dosing Recommendations in Adults and Pediatric Patients 1 year of age and older

  The recommended dose of ZINPLAVA is a single dose of 10 mg/kg administered as an intravenous infusion over 60 minutes. The safety and efficacy of repeat administration of ZINPLAVA in patients with CDI have not been studied.
  )
• Dilute prior to intravenous infusion. Administer via a low-protein binding 0.2 micron to 5 micron in-line or add-on filter. See Full Prescribing Information for dilution and administration instructions. (
  2.3 Preparation and Administration

  Preparation of Diluted Solution

  • ZINPLAVA must be diluted prior to intravenous infusion.
  • Prepare the diluted solution immediately after removal of the vial(s) from refrigerated storage, or the vial(s) may be stored at room temperature protected from light for up to 24 hours prior to preparation of the diluted solution.
  • Inspect vial contents for discoloration and particulate matter prior to dilution. ZINPLAVA is a clear to moderately opalescent, colorless to pale yellow solution. Do not use the vial if the solution is discolored or contains visible particles.
  • Do not shake the vial.
  • Withdraw the required volume from the vial(s) based on the patient's weight (in kg) and transfer into an intravenous bag containing either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP to prepare a diluted solution with a final concentration ranging from 1 mg/mL to 10 mg/mL. Mix diluted solution by gentle inversion. Do not shake.
  • Discard vial(s) and all unused contents.

  Storage of Diluted Solution

  • The product does not contain preservative. The diluted solution of ZINPLAVA may be stored either at room temperature for up to 16 hours or under refrigeration at 2°C to 8°C (36°F to 46°F) for up to 24 hours. If refrigerated, allow the intravenous bag to come to room temperature prior to use.
  • These time limits include storage of the infusion solution in the intravenous bag through the duration of infusion.
  • Do not freeze the diluted solution.

  Administration

  • Administer the diluted solution as an intravenous infusion over 60 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter.
  • The diluted solution can be infused via a central line or peripheral catheter. Do not administer ZINPLAVA as an intravenous push or bolus.
  • Do not co-administer other drugs simultaneously through the same infusion line.
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Injection: 1,000 mg/40 mL (25 mg/mL) clear to moderately opalescent, colorless to pale yellow solution in a single-dose vial.

Adequate and well controlled studies with ZINPLAVA have not been conducted in pregnant women. No animal reproductive and developmental studies have been conducted with bezlotoxumab.

The background risk of major birth defects and miscarriage for the indicated population is unknown; however, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.