Durvalumab is available as a 50-mg/mL concentrate for injection in 2.4- and 10-mL preservative-free, single-dose vials containing 120 and 500 mg, respectively, of the drug.3881 Each mL of the concentrate contains durvalumab 50 mg with L-histidine 2 mg, L-histidine hydrochloride monohydrate 2.7 mg, a,a-trehalose dihydrate 104 mg, and polysorbate 80 0.2 mg in water for injection.3881
The concentrate must be diluted prior to administration.3881 To prepare the drug for intravenous infusion, the appropriate dose of the concentrate should be withdrawn from the vial and added to an infusion bag containing dextrose 5% or sodium chloride 0.9% to yield a final durvalumab concentration between 1 and 15 mg/mL.3881 The solution should be mixed by gentle inversion and should not be shaken.3881 Any unused portion remaining in vials should be discarded.3881
Trade Name(s)
Imfinzi
Durvalumab is administered by intravenous infusion over 60 minutes only after dilution in dextrose 5% or sodium chloride 0.9%.3881 Diluted solutions for infusion should be administered through a 0.2- or 0.22-µm low protein-binding inline filter.3881
Other drugs should not be co-administered with durvalumab through the same infusion line.3881
Intact vials of durvalumab should be stored at 2 to 8°C in the original carton to protect from light and should not be shaken or frozen.3881 The concentrate for injection is a clear to opalescent, colorless to slightly yellow solution.3881 Vials should be visually inspected for particulate matter and discoloration prior to use; discard the solution if it is discolored, cloudy, or if particulate matter is present.3881
Stability of durvalumab concentrate for injection (AstraZeneca Canada) in opened vials was evaluated in a study using a variety of methods to assess physicochemical stability (visual inspection, spectrophotometry, pH and osmolality measurement, dynamic light scattering, steric exclusion high-performance liquid chromatography [HPLC], ion exchange HPLC, peptide mapping HPLC).4111 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, osmolality, 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.4111 Although not statistically significant, results from ion exchange HPLC revealed a slight increase in the formation of acidic variants, suggesting deamidation, on day 14 in vials stored at room temperature which was not observed in vials that were refrigerated.4111
The manufacturer states diluted solutions may be stored for no more than 8 hours at room temperature or 28 days at 2 to 8°C, including administration time.3881 Diluted solutions should not be frozen or shaken.3881
Filtration
Diluted solutions for infusion should be administered through a 0.2- to 0.22-µm low protein-binding inline filter.3881
For a list of references cited in the text of this monograph, search the monograph titled References.