Each vial is reconstituted and diluted for intravenous infusion. Each 2 mL of reconstituted solution contains 50 mg of pembrolizumab and is formulated in L-histidine (3.1 mg), polysorbate-80 (0.4 mg), sucrose (140 mg). May contain hydrochloric acid/sodium hydroxide to adjust pH to 5.5 14.1.6 Storage and Stability KEYTRUDA is supplied in a carton containing one 50 mg single-use vial (NDC 0006-3029-02). Store vials under refrigeration at 2°C to 8°C (36°F to 46°F). 14.1.7 Supplier Pharmacy will receive Merck Marketed Drug (MMD) (i.e., commercial supply) of pembrolizumab for use after 30 April 2020. This will replace the previous arrangement in which Merck was providing Pembrolizumab Lot R022867, which expires on 30 Apr 2020. 14.1.8 Mechanism of Action Pembrolizumab (previously known as SCH 900475) is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumor regression and ultimately immune rejection. 14.1.9 Administration for this study Intravenous 94 Abbreviated Title: GBM Pembro HSPPC Version Date: 03/26/2024 14.1.10 Preparation Product Name & Potency Dosage Form Pembrolizumab 50 mg Lyophilized Powder for Injection Pembrolizumab 100 mg/ 4mL Solution for Injection Drug will be supplied either as powder for injection, 50 mg single-use vial, or a liquid, DP 100 mg/vial (25 mg/mL), both in Type I glass vials intended for single use only. Reconstitution of Pembrolizumab Lyophilized Powder for Injection: Add 2.3 mL of Sterile Water for Injection, USP by injecting the water along the walls of the vial and not directly on the lyophilized powder (resulting concentration 25 mg/mL). Slowly swirl the vial.