Preparation and Handling
2.3.1 Items Required by the Pharmacy to Prepare Marqibo
•Marqibo Kit
•Water bath1
•Calibrated thermometer1 (0°C to 100°C)
•Calibrated electronic timer1
•Sterile venting needle or other suitable device equipped with a sterile 0.2 micron filter
•1 mL or 3 mL sterile syringe with needle, and
•5 mL sterile syringe with needle.
1
The manufacturer will provide the water bath, calibrated thermometer, and calibrated electronic timer to the medical facility at the initial order of Marqibo and will replace them every 2 years.
2.3.2 Preparation Instructions for Marqibo (vinCRIStine sulfate LIPOSOME injection), 5 mg/31 mL (0.16 mg/mL)

Procedures for handling and disposal of anticancer drugs should be followed [see References (15)].

Call [1 888 292 9617] if you have questions about the preparation of Marqibo. Marqibo takes approximately 60 to 90 minutes to prepare. The preparer should have dedicated uninterrupted time to prepare Marqibo due to the extensive monitoring of temperature and time required for the preparation.

Aseptic technique must be strictly observed since no preservative or bacteriostatic agent is present in Marqibo. The preparation steps of Marqibo that involve mixing the Sodium Phosphate Injection, Sphingomyelin/Cholesterol Liposome Injection, and VinCRIStine Sulfate Injection must be done in a biological safety cabinet or by established pharmacy safety procedures for the preparation of sterile injectable formulations and hazardous drugs. However, the preparation steps that involve placement of the vial in the water bath must be done outside of the sterile area.
Do not use with in-line filters. Do not mix with other drugs.
1.Fill a water bath with water to a level of at least 8 cm (3.2 inches) measured from the bottom and maintain this minimum water level throughout the procedure. The water bath must remain outside of the sterile area.
2.Place a calibrated thermometer in the water bath to monitor water temperature and leave it in the water bath until the procedure has been completed.
3.Preheat water bath to 63°C to 67°C. Maintain this water temperature until completion of the procedure using the calibrated thermometer.
4.Visually inspect each vial in the Marqibo Kit for particulate matter and discoloration prior to preparation, whenever solution and container permit. Do not use if a precipitate or foreign matter is present.
5.Remove all the caps on the vials and swab the vials with sterile alcohol pads.
6.Vent the Sodium Phosphate Injection vial with a sterile venting needle equipped with a sterile 0.2 micron filter or other suitable venting device in the biological safety cabinet. Always position venting needle point well above liquid level before adding Sphingomyelin/Cholesterol Liposome Injection and VinCRIStine Sulfate Injection.
7.Withdraw 1 mL of Sphingomyelin/Cholesterol Liposome Injection.
8.Inject 1 mL of Sphingomyelin/Cholesterol Liposome Injection into the Sodium Phosphate Injection vial.
9.Withdraw 5 mL of VinCRIStine Sulfate Injection.
10.Inject 5 mL of VinCRIStine Sulfate Injection into the Sodium Phosphate Injection vial.
11.Remove the venting needle and gently invert the Sodium Phosphate Injection vial 5 times to mix. DO NOT SHAKE.
12.Fit Flotation Ring around the neck of the Sodium Phosphate Injection vial.
13.Confirm that the water bath temp