Incompatibilities: Tremelimumab: No incompatibilities between IMJUDO and 9 g/L (0.9%) sodium chloride or 50 g/L (5%) dextrose in polyvinylchloride or polyolefin intravenous (IV) bags have been observed.
This drug product must not be mixed with other drug products except those mentioned in Instructions for use, handling and disposal.
Do not co-administer other drugs through the same intravenous line.
Instructions for use, handling and disposal: Preparation of solution: IMJUDO is supplied as a single-dose vial and does not contain any preservatives, aseptic technique must be observed.
Visually inspect drug product for particulate matter and discolouration. IMJUDO is clear to slightly opalescent, colourless to slightly yellow solution. Discard the vial if the solution is cloudy, discoloured or visible particles are observed. Do not shake the vial.
Withdraw the required volume from the vial(s) of IMJUDO and transfer into an IV bag containing 0.9% Sodium Chloride Injection, or 5% Dextrose Injection. Mix diluted solution by gentle inversion. The final concentration of the diluted solution should be between 0.1 mg/mL and 10 mg/mL. Do not freeze or shake the solution.
Care must be taken to ensure the sterility of prepared solutions.
Do not re-enter the vial after withdrawal of drug.
Discard any unused portion left in the vial.
Administration: Administer infusion solution intravenously over 1 hour through an intravenous line containing a sterile, low-protein binding 0.2 or 0.22 micron filter.
Do not co-administer other drugs through the same infusion line.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.