GAZYVA preparation and storage for CLL 1

Prepare the GAZYVA solution for infusion using aseptic technique as follows:

STEP 1
  • Inspect visually for any particulate matter and discoloration prior to administration
STEP 2
  • Dilute into 0.9% sodium chloride PVC or non-PVC polyolefin infusion bag
  • Do not use other diluents such as dextrose (5%)
STEP 3
Preparation of solution for infusion on day 1 (100 mg) and day 2 (900 mg) of Cycle 1:
  • Withdraw 40 mL of GAZYVA solution from the vial
  • Dilute 4 mL (100 mg) of GAZYVA into a 100 mL 0.9% sodium chloride infusion bag for immediate administration
  • Dilute the remaining 36 mL (900 mg) into a 250 mL 0.9% sodium chloride infusion bag at the same time for use on day 2 and store at 2°C to 8°C (36°F to 46°F) for up to 24 hours. After allowing the diluted bag to come to room temperature, use immediately
  • Clearly label each infusion bag
Preparation of solution for infusion on day 8 and 15 of Cycle 1 and day 1 Cycles 2–6:
  • Withdraw 40 mL of GAZYVA solution from the vial
  • Dilute 40 mL (1000 mg) into a 250 mL 0.9% sodium chloride infusion bag
STEP 4
  • Mix diluted solution by gentle inversion
  • Do not shake or freeze

Additional preparation information

  • For microbiological stability, the diluted GAZYVA infusion solution should be used immediately
  • Dilute under appropriate aseptic conditions
  • If not used immediately, the solution may be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) for up to 24 hours prior to use
  • The product can be administered at a final concentration of 0.4 mg/mL to 4 mg/mL

Additional storage information

  • GAZYVA 1000 mg/40 mL (25 mg/mL) single-dose vials containing preservative-free solution (NDC 50242-070-01) are stable at 2°C to 8°C (36°F to 46°F)
  • Do not use beyond expiration date stamped on carton
  • Protect GAZYVA vials from light
  • DO NOT FREEZE
  • DO NOT SHAKE