Ravulizumab-cwvz is available as a 10-mg/mL concentrate for injection in 30-mL single-dose vials, and as a 100-mg/mL concentrate for injection in 3- and 11-mL single-dose vials.4018 The 10-mg/mL concentrate contains, in each 30-mL vial, ravulizumab 300 mg with polysorbate 80 0.2 mg, sodium chloride 8.77 mg, sodium phosphate dibasic 1.78 mg, and sodium phosphate monobasic 0.46 mg in water for injection.4018 The 100-mg/mL concentrate contains, in each 3- or 11-mL vial, ravulizumab 300 or 1100 mg with L-arginine 4.33 mg, polysorbate 80 0.5 mg, sodium phosphate dibasic 4.42 mg, sodium phosphate monobasic 4.57 mg, and sucrose 50 mg in water for injection.4018
The concentrate must be diluted prior to administration.4018 Do not mix the 100-mg/mL (3-mL and 11-mL vials) and 10-mg/mL (30-mL vial) concentrations together.4018 To prepare the drug for intravenous infusion, the appropriate dose of the concentrate should be withdrawn from the necessary number of vials and diluted in an infusion bag with an equivalent volume of sodium chloride 0.9% to achieve half the original concentration.4018 The 100-mg/mL concentrate in 3- or 11-mL vials should be diluted to a final ravulizumab concentration of 50 mg/mL.4018 The 10-mg/mL concentrate in 30-mL vials should be diluted to a final ravulizumab concentration of 5 mg/mL.4018 The solution should be mixed gently; do not shake.4018 Any unused portion remaining in vials should be discarded.4018
pH
10-mg/mL concentrate for injection: 7.4018
100-mg/mL concentrate for injection: 7.4.4018
Trade Name(s)
Ultomiris
Ravulizumab-cwvz is administered by intravenous infusion through a 0.2- or 0.22-µm filter.4018 The infusion rate and time depend on the dose; consult product labeling for additional details on minimum infusion times and maximum infusion rates.4018
Diluted solutions should be allowed to equilibrate with room temperature (18 to 25ºC) prior to administration; do not heat in a microwave or with any heat source other than ambient air temperature.4018 Following infusion, the administration line should be flushed with sodium chloride 0.9%.4018
Ravulizumab concentrate 10 mg/mL is a clear to translucent, slight whitish solution.4018 Ravulizumab concentrate 100 mg/mL is a translucent, clear to yellowish solution.4018 Intact vials should be stored at 2 to 8°C in the original carton to protect from light.4018 Do not shake or freeze.4018
Diluted solutions should be protected from light and may be stored at 2 to 8°C for no more than 24 hours (including expected infusion time).4018 Once removed from refrigeration, diluted solutions should be administered within 6 hours if prepared from the 10-mg/mL concentrate (30 mL vials) or within 4 hours if prepared from the 100-mg/mL concentrate (3 or 11 mL vials).4018
Filtration
Diluted solutions for infusion should be administered through a 0.2- or 0.22-µm filter.4018
For a list of references cited in the text of this monograph, search the monograph titled References.