Gazyva Caution For Usage

Special Instructions for Use, Handling and Disposal: Instructions for dilution: GAZYVA should be prepared by a healthcare professional using aseptic technique.
For CLL cycles 2-6 and all FL cycles: Withdraw 40 mL of GAZYVA liquid concentrate from the vial and dilute in PVC or non-PVC polyolefin infusion bags containing sterile, non-pyrogenic 0.9% aqueous sodium chloride solution.
For preparation of infusion bags for CLL only Cycle 1, Day 1 dose administered over 2 days: To ensure differentiation of the two infusion bags for the initial 1000 mg dose, the recommendation is to utilise bags of different sizes to distinguish between the 100 mg dose for Cycle 1 Day 1 and the 900 mg dose for Cycle 1 Day 1 (continued) or Day 2. To prepare the 2 infusion bags, withdraw 40 mL of GAZYVA liquid concentrate from vial and dilute 4mL into a 100 mL infusion bag and the remaining 36mL in a 250 mL PVC or non-PVC polyolefin infusion bags containing sterile, non-pyrogenic 0.9% aqueous sodium chloride solution. Clearly label each infusion bag. (See Table 9.)

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Do not use other diluents such as Dextrose (5%) solution (see Incompatibilities as follows).
The bag should be gently inverted to mix the solution in order to avoid excessive foaming.
Parenteral drug products should be inspected visually for particulates and discoloration prior to administration.
Incompatibilities: No incompatibilities between GAZYVA and polyvinyl chloride or polyethylene or polypropylene or polyolefine bags or polyvinyl chloride (PVC) or polyurethane (PUR) or polyethylene (PE) infusion sets as well as optional inline filters with product contact surfaces of polyethersulfon (PES), a 3-way stopcock infusion aid made from polycarbonate (PC), and catheters made from polyetherurethane (PEU) have been observed in concentration ranges from 0.4 mg/mL to 20.0 mg/mL after dilution of GAZYVA with 0.9% sodium chloride. Diluted product should not be shaken or frozen.
Do not use other diluents such as Dextrose (5%) solution to dilute GAZYVA since its use has not been tested.
Disposal of unused/expired medicines: The release of pharmaceuticals in the environment should be minimized. Medicines should not be disposed of via wastewater and disposal through household waste should be avoided. Use established "collection systems", if available in location.