HOW TO USE Pemaxa

How to use Pemaxa:

  • PEMAXA is a cytotoxic drug. Follow applicable special handling and disposal procedures.
  • Calculate the dose of PEMAXA and determine the number of vials needed.
  • Reconstitute PEMAXA to achieve a concentration of 25 mg/mL as follows:
  • Reconstitute each 100-mg vial with 4.2 mL of 0.9% Sodium Chloride Injection, USP (preservative-free)
  • Reconstitute each 500-mg vial with 20 mL of 0.9% Sodium Chloride Injection, USP (preservative-free)
  • Do not use calcium-containing solutions for reconstitution.
  • Gently swirl each vial until the powder is completely dissolved. The resulting solution is clear and ranges in color from colorless to yellow or green-yellow. FURTHER DILUTION IS REQUIRED prior to administration.
  • Store reconstituted, preservative-free product under refrigerated conditions [2-8 °C (36-46 °F)] for no longer than 24 hours from the time of reconstitution. Discard vial after 24 hours.
  • Inspect reconstituted product visually for particulate matter and discoloration prior to further dilution. If particulate matter is observed, discard vial.
  • Withdraw the calculated dose of PEMAXA from the vial(s) and discard vial with any unused portion.
  • Further, dilute PEMAXA with 0.9% Sodium Chloride Injection (preservative-free) to achieve a total volume of 100 mL for intravenous infusion.
  • Store diluted, reconstituted product under refrigerated conditions [2-8 °C (36-46 °F)] for no more than 24 hours from the time of reconstitution. Discard after 24 hours.