Vyloy Caution For Usage

Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Special precautions for disposal and other handling: Instructions for preparation and administration: Reconstitution in single-dose vial: Follow procedures for proper handling and disposal of anticancer medicinal products.
Use appropriate aseptic technique for reconstitution and preparation of solutions.
Calculate the recommended dose based on the patient's body surface area to determine the number of vials needed.
Reconstitute each vial as follows. If possible, direct the stream of sterile water for injections (SWFI) along the walls of the vial and not directly onto the lyophilized powder: a. 100 mg vial: Slowly add 5 mL of SWFI, resulting in 20 mg/mL zolbetuximab.
Slowly swirl each vial until the contents are completely dissolved. Allow the reconstituted vial(s) to settle. Visually inspect the solution until the bubbles are gone. Do not shake the vial.
Visually inspect the solution for particulate matter and discoloration. The reconstituted solution should be clear to slightly opalescent, colorless to slight yellow and free of visible particles. Discard any vial with visible particles or discoloration.
Based upon the calculated dose amount, the reconstituted solution from the vial(s) should be added to the infusion bag immediately. This product does not contain a preservative. If not used immediately, refer to Shelf life under Storage for storage of reconstituted vials.
Dilution in infusion bag: Withdraw the calculated dose amount of reconstituted solution from the vial(s) and transfer into an infusion bag.
Dilute with sodium chloride 9 mg/mL (0.9%) solution for infusion. The infusion bag size should allow enough diluent to achieve a final concentration of 2 mg/mL zolbetuximab.
The diluted dosing solution of zolbetuximab is compatible with intravenous infusion bags composed of polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC) with either plasticizer [Di-(2-ethylhexyl) phthalate (DEHP) or Trioctyl trimellitate (TOTM)], ethylene propylene copolymer, ethylene-vinyl acetate (EVA) copolymer, PP and styrene-ethylene-butylene-styrene copolymer, or glass (bottle for administration use), and infusion tubing composed of PE, PVC with either plasticizer [DEHP, TOTM or Di(2-ethylhexyl) terephthalate], polybutadiene (PB), or elastomer modified PP with in-line filter membranes (pore size 0.2 μm) composed of polyethersulfone (PES) or polysulfone.
Mix diluted solution by gentle inversion. Do not shake the bag.
Visually inspect the infusion bag for any particulate matter prior to use. The diluted solution should be free of visible particles. Do not use the infusion bag if particulate matter is observed.
Discard any unused portion left in the single-dose vials.
Administration: Do not co-administer other medicinal products through the same infusion line.
Administer the infusion immediately over a minimum of 2 hours through an intravenous line. Do not administer as an intravenous push or bolus.
No incompatibilities have been observed with closed system transfer device composed of PP, PE, stainless steel, silicone (rubber/oil/resin), polyisoprene, PVC or with plasticizer [TOTM], acrylonitrile-butadiene-styrene (ABS) copolymer, methyl methacrylate-ABS copolymer, thermoplastic elastomer, polytetrafluoroethylene, polycarbonate, PES, acrylic copolymer, polybutylene terephthalate, PB, or EVA copolymer.
No incompatibilities have been observed with central port composed of silicone rubber, titanium alloy or PVC with plasticizer [TOTM].
In-line filters (pore size of 0.2 μm with materials listed previously) are recommended to be used during administration.
If not administered immediately, refer to Shelf life under Storage for storage of the prepared infusion bag.
Disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.