Cemiplimab-rwlc is available as a 50-mg/mL concentrate for injection in 7-mL preservative-free, single-dose vials containing 350 mg of the drug.3883 Each mL of the concentrate contains cemiplimab 50 mg, L-histidine 0.74 mg, L-histidine monohydrochloride monohydrate 1.1 mg, sucrose 50 mg, L-proline 15 mg, and polysorbate 80 2 mg in water for injection.3883
The concentrate must be diluted prior to administration.3883 To prepare the drug for intravenous infusion, withdraw 7 mL of the concentrate from the vial and dilute in dextrose 5% or sodium chloride 0.9% to yield a final cemiplimab concentration between 1 and 20 mg/mL.3883 The solution should be mixed by gentle inversion and should not be shaken.3883 Any unused portion remaining in vials should be discarded.3883
pH
6.3883
Trade Name(s)
Libtayo
Cemiplimab is administered by intravenous infusion over 30 minutes only after dilution in dextrose 5% or sodium chloride 0.9%.3883 Diluted solutions for infusion should be administered through a 0.2- to 5-µm low protein-binding add-on or inline filter.3883
Intact vials of cemiplimab-rwlc should be stored at 2 to 8°C in the original carton to protect from light and should not be shaken or frozen.3883 The concentrate for injection is a clear to slightly opalescent, colorless to pale yellow solution that may contain trace amounts of translucent to white particles.3883 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 other than trace amounts of translucent to white particles is present.3883
The manufacturer states diluted solutions may be stored for no more than 8 hours at room temperature or 24 hours at 2 to 8°C, including administration time.3883 Refrigerated solutions should be allowed to come room temperature prior to administration.3883 Diluted solutions should not be frozen.3883
Filtration
Diluted solutions for infusion should be administered through a 0.2- to 5-µm low protein-binding add-on or inline filter.3883
For a list of references cited in the text of this monograph, search the monograph titled References.