Vincristine sulfate liposomal injection is prepared from a kit containing single-use vials of vincristine sulfate solution (5 mg/5 mL), sphingomyelin-cholesterol liposome suspension (1 mL), and sodium phosphate solution (25 mL).3024 CAUTION: Care should be taken to ensure that the correct drug product, dose, and administration procedures are used and that no confusion with other products occurs.
When prepared as directed from the kit components, the resultant product is a white to off-white translucent suspension containing liposome-encapsulated vincristine sulfate 0.16 mg/mL (i.e., 5 mg in a total volume of 31 mL of suspension).3024 Each vial of vincristine sulfate liposomal injection prepared from the kit components also contains mannitol 500 mg, sphingomyelin 73.5 mg, cholesterol 29.5 mg, sodium citrate 36 mg, citric acid 38 mg, sodium phosphate 355 mg, and sodium chloride 225 mg in 31 mL of suspension.3024 Over 95% of the vincristine sulfate in the resulting liposomal suspension is provided inside liposome carriers (mean diameter 100 nm), which are composed of sphingomyelin and cholesterol.3024
To prepare vincristine sulfate liposomal injection, a water bath should be prepared and maintained outside of the sterile area using equipment provided by the manufacturer (i.e., water bath, calibrated thermometer and timer).3024 The depth of the water bath should be at least 8 cm and the temperature of the water bath should be maintained at 63 to 67°C throughout the preparation procedure.3024 All steps required to mix and dilute the product should be performed inside the sterile area.3024
Each vial of the kit should be visually inspected for particulate matter and discoloration prior to use whenever solution and container permit; vials should not be used if a precipitate or foreign matter is present.3024 A venting needle (or other suitable venting device) with a 0.2-µm filter should be inserted into the vial of sodium phosphate solution, taking care to position the venting needle well above the liquid level of the solution prior to addition of the other components.3024 One mL should be withdrawn from the vial of sphingomyelin-cholesterol liposome injection and transferred to the vial containing sodium phosphate solution.3024 Five mLs of solution should then be withdrawn from the vial containing vincristine sulfate and transferred to the vial containing the sodium phosphate and sphingomyelin-cholesterol liposome components.3024 The venting needle should then be removed from the sodium phosphate vial and the vial should be gently inverted 5 times to mix the 3 components; shaking should be avoided.3024
After confirming that the temperature of the water bath has warmed to 63 to 67°C, the neck of the sodium phosphate vial containing the mixture of the 3 components should be fitted with the flotation ring and transferred from the sterile area to the water bath.3024 The vial should remain in the water bath for 10 minutes; the temperature of the water bath and duration of flotation should be closely monitored using the manufacturer-provided calibrated thermometer and electronic timer.3024 After 10 minutes, the vial should be removed from the water bath using tongs to prevent burns, and the flotation ring should be removed from the vial.3024 The start time and temperature and the end time and temperature should be recorded on the provided vincristine sulfate liposomal injection overlabel immediately after the vial is placed into the water bath and upon removal, respectively.3024 The vial exterior should be dried with a clean paper towel upon removal from the water bath, and the vincristine sulfate liposomal injection overlabel should be affixed.3024 The vial should be gently inverted another 5 times to mix the contents; shaking should be avoided.3024 The resultant vincristine sulfate liposomal injection should be allowed to equilibrate to controlled room temperature (i.e., 15 to 30°C) for at least 30 minutes.3024
Vincristine sulfate liposomal injection must be diluted in an appropriate infusion solution (i.e., dextrose 5% or sodium chloride 0.9%) before administration.3024 A volume equivalent to the volume of the appropriate dose of vincristine sulfate liposomal should be withdrawn from a 100-mL infusion bag of dextrose 5% or sodium chloride 0.9% prior to addition of the drug.3024 The appropriate dose of vincristine sulfate liposomal injection should then be transferred to the infusion bag to yield a final volume of 100 mL; the infusion bag label supplied by the drug's manufacturer should be completed and affixed to the bag.3024
Specific product labeling should be consulted for additional details on the preparation process for liposomal vincristine sulfate injection.3024 Deviations from temperature control, timing, and preparation instructions may affect encapsulation of vincristine sulfate into the liposomes.3024 In the case of such deviations, the manufacturer recommends discarding the components of the kit and using a new kit to prepare vincristine sulfate liposomal injection.3024
Trade Name(s)
Marqibo
Vincristine sulfate liposomal injection is administered by intravenous infusion over 1 hour only after preparation of the liposomal suspension as directed (see Products), followed by dilution in dextrose 5% or sodium chloride 0.9%.3024 The manufacturer states that the drug is fatal if given by other routes.3024 Death has occurred with intrathecal use; such use is contraindicated.3024
CAUTION: Care should be taken to ensure that the correct drug product, dose, and administration procedures are used and that no confusion with other products occurs.
All intact vials of vincristine sulfate injection solution, sphingomyelin-cholesterol liposome injection suspension, and sodium phosphate injection solution contained in the kit used in the preparation of vincristine sulfate liposomal injection should be stored at 2 to 8°C and should not be frozen.3024
Following constitution, vincristine sulfate liposomal injection should be stored at 15 to 30°C for no more than 12 hours.3024 Once diluted in the infusion bag, administration of diluted vincristine sulfate liposomal injection should be completed within 12 hours of initiation of vincristine sulfate liposomal injection preparation.3024
Filtration
Although a venting needle (or other suitable venting device) with a 0.2-µm filter should be used in the preparation of vincristine sulfate liposomal injection, inline filters should not be used during administration.3024
For a list of references cited in the text of this monograph, search the monograph titled References.