Special Instructions for Use, Handling and Disposal: The 1200 mg pertuzumab/600 mg trastuzumab and 600 mg pertzumab/600 mg trastuzumab solution are ready to use solutions for injection which does not need to be mixed with other drugs or diluted.
Phesgo should be inspected visually to ensure there is no particulate matter or discolouration prior to administration. Do not shake.
Phesgo solution for injection is for single use only and should be prepared by a healthcare professional using aseptic technique.
From a microbiological point of view, the medicine should be used immediately once transferred from the vial to the syringe since the medicine does not contain any antimicrobial-preservative. If not used immediately, preparation should take place in controlled and validated aseptic conditions. Once transferred from the vial to the syringe, the medicinal product is physically and chemically stable for 28 days at 2°C - 8°C or 24 hours at 9°C - 30°C.
After transfer of the solution to the syringe, it is recommended to replace the transfer needle by a syringe closing cap to avoid drying of the solution in the needle and not compromise the quality of the medicinal product. Label the syringe with the peel-off sticker. The hypodermic injection needle must be attached to the syringe immediately prior to administration followed by volume adjustment to 10 mL (600 mg pertuzumab/600 mg trastuzumab) or 15 mL (1200 mg pertuzumab/600 mg trastuzumab).
No incompatibilities between Phesgo and polypropylene, polycarbonate, polyurethane, polyethylene, polyvinyl chloride and fluorinated ethylene polypropylene have been observed.
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.
The following points should be strictly adhered to regarding the use and disposal of syringes and other medicinal sharps: Needles and syringes should never be reused.
Place all used needles and syringes into a sharps container (puncture-proof disposable container).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.