Pembrolizumab is available as a 10-mg/mL concentrate for injection in 4-mL preservative-free, single-dose vials containing 100 mg of the drug.3877 Each mL of the concentrate contains pembrolizumab 25 mg with L-histidine 1.55 mg, polysorbate 20 0.2 mg, and sucrose 70 mg in water for injection.3877
The concentrate must be diluted prior to administration.3877 To prepare the drug for intravenous infusion, the appropriate dose of the concentrate should be withdrawn from the vial and diluted in dextrose 5% or sodium chloride 0.9% to yield a final pembrolizumab concentration between 1 and 10 mg/mL.3877 The solution should be mixed by gentle inversion and should not be shaken.3877 Any unused portion remaining in vials should be discarded.3877
Trade Name(s)
Keytruda
Pembrolizumab is administered by intravenous infusion over 30 minutes only after dilution in dextrose 5% or sodium chloride 0.9%.3877 Diluted solutions for infusion should be administered through a 0.2- or 5-µm low protein-binding add-on or inline filter.3877
Other drugs should not be co-administered with pembrolizumab through the same infusion line.3877
Intact vials of pembrolizumab should be stored at 2 to 8°C in the original carton to protect from light and should not be shaken or frozen.3877 The concentrate for injection is a clear to slightly opalescent, colorless to slightly yellow solution.3877 Vials should be visually inspected for particulate matter and discoloration prior to use; discard the solution if particulate matter is present.3877
Stability of pembrolizumab concentrate for injection (Merck Canada) in opened vials was evaluated in a study using a variety of methods to assess physicochemical stability (visual inspection, spectrophotometry, dynamic light scattering, pH measurement, size exclusion high-performance liquid chromatography [HPLC], ion exchange HPLC, peptide mapping HPLC).4112 Following puncture of and withdrawal of solution from the original vials with an 18-gauge, 1-inch needle on days 0, 7, and 14, no significant changes in visual appearance, pH, turbidity, charge distribution, or primary structure, or evidence of aggregation or fragmentation were observed in 14 days when stored at either room temperature or at 4°C.4112
The manufacturer states diluted solutions may be stored for no more than 6 hours at room temperature or 96 hours at 2 to 8°C, including administration time.3877 Diluted solutions should be discarded after 6 hours at room temperature or 96 hours at 2 to 8°C.3877 Refrigerated solutions should be allowed to come room temperature prior to administration.3877 Diluted solutions should not be shaken or frozen.3877
Filtration
Diluted solutions for infusion should be administered through a 0.2- to 5-µm low protein-binding add-on or inline filter.3877
For a list of references cited in the text of this monograph, search the monograph titled References.