Carfilzomib is available as a lyophilized powder in single-dose vials containing 10, 30, or 60 mg of carfilzomib.4072 Each 10-, 30-, or 60-mg vial contains sulfobutylether ß-cyclodextrin 500-, 1500, or 3000-mg, respectively, with citric acid and sodium hydroxide for pH adjustment.4072
Reconstitute each 10, 30, or 60 mL vial with 5, 15, or 29 mL of sterile water for injection to yield a 2-mg/mL solution.4072 Direct the stream of diluent along the vial wall to minimize foaming.4072 After adding the diluent, the vial should be gently swirled and/or inverted slowly for about 1 minute, or until complete dissolution occurs.4072 Do not shake.4072 If foaming occurs, allow the solution to rest until foaming subsides (approximately 5 minutes) and the solution is clear.4072
The reconstituted solution may be further diluted in dextrose 5% in a 50- to 100-mL infusion bag.4072
The manufacturer states there is no data to support the use of closed system transfer devices with carfilzomib.4072
The manufacturer states that unused portions from the vials should not be pooled and that a vial should not be used for more than 1 dose.4072
pH
3.5.4072
Trade Name(s)
Kyprolis
Carfilzomib is administered by intravenous infusion following reconstitution, either undiluted or diluted in dextrose 5%.4072 Do not administer by intravenous push or bolus injection.4072
The administration line should be flushed with normal saline or dextrose 5% immediately before and after carfilzomib administration.4072
Intact vials should be stored at 2 to 8°C in the original package to protect from light.4072
Carfilzomib is a white to off-white lyophilized powder that forms a clear, colorless solution upon reconstitution.4072
Reconstituted solutions in the vial or a syringe, or further diluted in dextrose 5% in an infusion bag are stated to be stable for 24 hours at 2 to 8°C or for 4 hours at room temperature (15 to 30°C).4072 Product labeling states the total time from reconstitution to administration should not exceed 24 hours.4072 However, in one study, carfilzomib (Amgen) reconstituted as recommended in the original vials and stored at 2 to 8°C was stable for 28 days with 2% loss.4073 Reconstituted solutions transferred to syringes (BD Luer-Lok) and stored at 25°C were stable for 14 days with 12.6% loss by day 28.4073
For a list of references cited in the text of this monograph, search the monograph titled References.