ate 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
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.
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.
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 Solution Stabilizer.
The addition of preservative-free Sterile Water for Injection, USP, to the lyophilized powder results in a final BLINCYTO concentration of 12.5 mcg/mL.
Visually inspect the reconstituted solution for particulate matter and discoloration during reconstitution and prior to infusion. The resulting solution should be clear to slightly opalescent, colorless to slightly yellow. Do not use if solution is cloudy or has precipitated.
Using a 1 mL syringe, aseptically transfer 0.83 mL of reconstituted BLINCYTO into the IV bag. Gently mix the contents of the bag to avoid foaming.
Under aseptic conditions, attach the IV tubing to the IV bag with the sterile 0.2 micron in-line filter.
Remove air from the IV bag and prime the IV line only with the prepared solution for infusion. Do not prime with 0.9% Sodium Chloride.
Store at 2°C to 8°C if not |
