Preparation and Administration: Protect from light. Do not freeze. Do not shake.
Equilibrate the vial of Pembrolizumab (KEYTRUDA) to room temperature.
Prior to dilution, the vial of liquid can be out of refrigeration (temperatures at or below 25°C) for up to 24 hours.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Pembrolizumab (KEYTRUDA) is a clear to slightly opalescent, colorless to slightly yellow solution. Discard the vial if visible particles are observed.
Withdraw the required volume up to 4 mL (100 mg) of Pembrolizumab (KEYTRUDA) and transfer into an intravenous bag containing 0.9% sodium chloride or 5% glucose (dextrose) to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL. Mix diluted solution by gentle inversion.
Do not freeze the infusion solution.
The product does not contain preservative. The diluted product should be used immediately. If not used immediately, diluted solutions of Pembrolizumab (KEYTRUDA) solutions may be stored at room temperature for a cumulative time of up to 6 hours. Diluted solutions of Pembrolizumab (KEYTRUDA) may also be stored under refrigeration at 2°C to 8°C; however, the total time from dilution of Pembrolizumab (KEYTRUDA) to completion of infusion should not exceed 24 hours. If refrigerated, allow the vials and/or IV bags to come to room temperature prior to use.
Administer infusion solution intravenously over 30 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 to 5 μm in-line or add-on filter.
Do not co-administer other drugs through the same infusion line.
Discard any unused portion left in the vial.