Special Instructions for Use, Handling and Disposal: Instructions for dilution: Perjeta is for single use only and is administered intravenously by infusion.
Perjeta does not contain any antimicrobial preservative. Therefore, care must be taken to ensure the sterility of the prepared solution for infusion and should be prepared by a healthcare professional.
Perjeta should be prepared by a healthcare professional using aseptic technique.
14 mL Perjeta liquid concentrate should be withdrawn from the vial using a sterile needle and syringe and diluted into a 250 mL PVC or non-PVC polyolefin 0.9% sodium chloride infusion bag. Do not withdraw saline out of the infusion bag.
After dilution, the solution should contain a nominal concentration of 3.0 mg/mL of pertuzumab for the initial dose where two vials are required and 1.6 mg/mL of pertuzumab for the subsequent dose where one vial is required.
Dextrose (5%) solution should not be used (see Incompatibilities as follows).
The bag should be gently inverted to mix the solution in order to avoid foaming.
Parenteral drug products should be inspected visually for particulates and discoloration prior to administration. Once the infusion is prepared it should be administered immediately (see Storage).
Incompatibilities: No incompatibilities between Perjeta and polyvinylchloride, polyethylene or non-PVC polyolefin bags have been observed.
Dextrose (5%) solution should not be used to dilute Perjeta since it was chemically and physically unstable in such solutions (dilute formulations of Perjeta liquid formulations in D5W IV bags did not maintain stable pH after storage at room temperature (27-33°C) for 24 hours followed by 24 hours at refrigerator temperature (2-8°C)).
Perjeta should not be mixed or diluted with other drugs.
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.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.