Eculizumab is available as a 10-mg/mL concentrate for injection in 30-mL preservative-free, single-dose vials containing 300 mg of the drug.4019 Each 30-mL vial contains eculizumab 300 mg, polysorbate 80 6.6 mg, sodium chloride 263.1 mg, sodium phosphate dibasic 53.4 mg, and sodium phosphate monobasic 13.8 mg in water for injection.4019
The concentrate must be diluted prior to administration.4019 To prepare the drug for intravenous infusion, the appropriate dose of the concentrate should be transferred to an infusion bag and diluted with an equivalent volume of a compatible infusion solution (sodium chloride 0.9%, sodium chloride 0.45%, dextrose 5%, or Ringer's injection) to yield a final eculizumab concentration of 5 mg/mL.4019 The solution should be inverted gently to mix.4019 Any unused portion remaining in vials should be discarded.4019
pH
Concentrate for injection: 7.4019
Trade Name(s)
Soliris
Eculizumab is administered by intravenous infusion over 35 minutes in adults or 1 to 4 hours in pediatric patients via gravity feed or infusion or syringe pump.4019
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.4019
Eculizumab concentrate for injection is a clear, colorless solution.4019 Intact vials should be stored at 2 to 8°C in the original carton to protect from light.4019 Do not shake or freeze.4019 Intact vials may be stored at controlled room temperature in the outer carton for a single period up to 3 days.4019
Diluted solutions are stated to be stable for 24 hours at 2 to 8°C or at room temperature.4019
For a list of references cited in the text of this monograph, search the monograph titled References.