AHFS Class:
90:20 Complement Inhibitor Agents
Generic Name
Crovalimab-akkz is available as a 170-mg/mL injection solution in 2-mL preservative-free, single-dose vials containing 340 mg of the drug.4026 Each 2-mL vial contains crovalimab 340 mg, arginine hydrochloride 42.2 mg, histidine 9.4 mg, and poloxamer 188 1 mg in water for injection; aspartic acid may have been added for pH adjustment.4026
To prepare a solution for intravenous infusion, the appropriate volume of the injection solution should be withdrawn from the necessary number of vials and diluted in 100 or 250 mL of sodium chloride 0.9% to yield a final crovalimab concentration of 4 to 15 mg/mL.4026 The solution should be mixed by gentle inversion; do not shake.4026 Any unused portion remaining in vials should be discarded.4026
pH
5.8.4026
Trade Name(s)
Piasky
Crovalimab-akkz is administered by intravenous infusion (first dose) or subcutaneous injection (subsequent doses).4026 The first dose is administered by intravenous infusion following dilution.4026 Subsequent doses are administered undiluted by subcutaneous injection.4026
For intravenous infusion, the appropriate dose should be diluted in 100 or 250 mL of sodium chloride 0.9% and administered through a dedicated infusion line with a 0.2-µm inline filter over 60 or 90 minutes, depending on the dose.4026 Following infusion, the administration line should be flushed with a compatible infusion solution to ensure delivery of the entire dose.4026
For subcutaneous injection, the drug is administered undiluted as a 2-mL (340 mg) injection.4026 A dose of 680 or 1020 mg is administered as 2 or 3 consecutive subcutaneous injections, respectively, of 340 mg each.4026 The manufacturer recommends using a 2- or 3-mL polypropylene or polycarbonate syringe with Luer-lock or Luer-slip tip for each injection.4026
Crovalimab-akkz is a clear to opalescent, almost colorless to brownish-yellow solution.4026 Visually inspect vials prior to use; do not use the solution if cloudiness, discoloration, or particulate matter is present.4026
Intact vials should be stored at 2 to 8°C in the outer carton to protect from light and should not be shaken or frozen.4026 Intact vials may be stored at room temperature up to 30°C in the outer carton for no longer than 7 days and may be returned to refrigeration; however the total combined time at room temperature should not exceed 7 days.4026
Diluted solutions prepared in infusion bags composed of polyolefins, polyethylene, or polypropylene may be stored at 2 to 8°C protected from light for up to 64 hours and up to an additional 6 hours (including infusion time) at room temperature up to 30°C in ambient light.4026 Protect from direct sunlight.4026
Diluted solutions prepared in PVC infusion bags may be stored at 2 to 8°C protected from light for up to 12 hours and up to an additional 6 hours (including infusion time) at room temperature up to 30°C in ambient light.4026 Protect from direct sunlight.4026
Syringes prepared for subcutaneous injection should be used immediately.4026 If immediate use is not possible, the capped syringes may be stored at 2 to 8°C for up to 64 hours protected from light and up to 5 hours at room temperature up to 30°C in ambient light.4026 Protect from direct sunlight.4026
Sorption
The manufacturer states no incompatibilities have been observed between crovalimab-akkz and infusion bags containing PVC or polyolefins such as polyethylene and polypropylene.4026
In addition, no incompatibilities have been observed between crovalimab-akkz with infusion sets or infusion aids containing PVC, polyethylene, polyurethane, polybutadiene, acrylonitrile butadiene styrene, polycarbonate, or polytetrafluorethylene.4026
Filtration
Diluted solutions for infusion should be administered through a 0.2-µm inline filter.4026
For a list of references cited in the text of this monograph, search the monograph titled References.