Do not prime with 0.9% Sodium Chloride.
Store at 2°C to 8°C if not used immediately.
2.4.4.4 Preparation of BLINCYTO 28 mcg/day infused over 48 hours at a rate of 5 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 5.6 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 vials.
Use two vials of BLINCYTO. Using a 5 mL syringe, reconstitute each 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 3 mL syringe, aseptically transfer 5.2 mL of reconstituted BLINCYTO into the IV bag (2.7 mL from one vial and the remaining 2.5 mL from the second vial). 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 used immediately.
2.5 Storage RequirementsThe information in Table 1 indicates the storage time for the reconstituted BLINCYTO vial and prepared IV bag containing BLINCYTO solution for infusion. Lyophilized BLINCYTO vial and IV Solution Stabilizer may be stored for a maximum of 8 hours at room temperature.
Table 1. Storage Time for Reconstituted BLINCYTO and IV Solution Stabilizer * While stored, protect BLINCYTO and IV Solution Stabilizer vials from light. † Storage time includes infusion time. If IV bag containing BLINCYTO solution for infusion is not administered within the time frames and temperatures indicated, it must be discarded; it should not be refrigerated again.
Maximum Storage Time
of Reconstituted BLINCYTO Vial*
Maximum Storage Time
of Prepared IV Bag Containing
BLINCYTO Solution for Infusion
Room Temperature
23°C to 27°C
(73°F to 81°F)
Refrigerated
2°C to 8°C
(36°F to 46°F)
Room Temperature
23°C to 27°C
(73°F to 81°F)
Refrigerated
2°C to 8°C
(36°F to 46°F)
4 hours
24 hours
48 hours†
8 days
3. DOSAGE FORMS AND STRENGTHS
For injection: 35 mcg of lyophilized powder in a single-use vial for reconstitution.
4. CONTRAINDICATIONS
BLINCYTO is contraindicated in patients with known hypersensitivity to blinatumomab or to any c |
