Aseptic technique must be strictly observed when preparing the solution for infusion since BLINCYTO vials do not contain antimicrobial preservatives. To prevent accidental contamination, prepare BLINCYTO according to aseptic standards, including but not limited to:
   

•Preparation must be done in a USP <797> compliant facility.
•Preparation must be done in an ISO Class 5 laminar flow hood or better.
•The admixing area should have appropriate environmental specifications, confirmed by periodic monitoring.
•Personnel should be appropriately trained in aseptic manipulations and admixing of oncology drugs.
•Personnel should wear appropriate protective clothing and gloves.
•Gloves and surfaces should be disinfected.
2.4.3    SPECIAL CONSIDERATIONS TO SUPPORT ACCURATE PREPARATION
    

A) IV Solution Stabilizer is provided with the BLINCYTO package and is used to coat the prefilled IV bag prior to addition of reconstituted BLINCYTO to prevent adhesion of BLINCYTO to IV bags and IV lines. Therefore, add IV Solution Stabilizer to the IV bag containing 0.9% Sodium Chloride. Do not use IV Solution Stabilizer for reconstitution of BLINCYTO.

B) The entire volume of the admixed BLINCYTO will be more than the volume administered to the patient (240 mL) to account for the priming of the IV line and to ensure that the patient will receive the full dose of BLINCYTO.

C) When preparing an IV bag, remove air from IV bag. This is particularly important for use with an ambulatory infusion pump.

D) Use the specific volumes described in the admixing instructions [see Dosage and Administration (2.4.4)] to minimize errors in calculation.

2.4.4    Preparation of BLINCYTO Solution for Infusion Using a Prefilled 250 mL 0.9% Sodium Chloride IV Bag

Specific admixing instructions are provided for each dose and infusion time.  Verify the prescribed dose and infusion time of BLINCYTO and identify the appropriate dosing preparation section listed below.  Follow the steps for reconstituting BLINCYTO and preparing the IV bag.

•See section 2.4.4.1 for 9 mcg/day infused over 24 hours at a rate of 10 mL/h.
•See section 2.4.4.2 for 9 mcg/day infused over 48 hours at a rate of 5 mL/h.
•See section 2.4.4.3 for 28 mcg/day infused over 24 hours at a rate of 10 mL/h.
•See section 2.4.4.4 for 28 mcg/day infused over 48 hours at a rate of 5 mL/h.
2.4.4.1 Preparation of BLINCYTO 9 mcg/day infused over 24 hours at a rate of 10 mL/h
    

1.Use a prefilled 250 mL 0.9% Sodium Chloride IV bag. 250 mL-prefilled bags typically contain overfill to a total volume of 265 to 275 mL. If necessary adjust the IV bag volume by adding or removing 0.9% Sodium Chloride to achieve a starting volume between 265 and 275 mL.
2.Using a 10 mL syringe, aseptically transfer 5.5 mL of IV Solution Stabilizer to the IV bag with 0.9% Sodium Chloride. Gently mix the contents of the bag to avoid foaming. Discard remaining IV Solution Stabilizer vial.
3.Using a 5 mL syringe, reconstitute one vial of BLINCYTO using 3 mL of preservative-free Sterile Water for Injection, USP. Direct preservative-free Sterile Water for Injection, USP, toward the side of the vial during reconstitution. Gently swirl contents to avoid excess foaming. Do not shake.
•Do not reconstitute BLINCYTO with IV Solu