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Indication
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BLINCYTO® (blinatumomab) is indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials.
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Indication
BLINCYTO® (blinatumomab) for injection 35 mcg single-use vial
RECONSTITUTION AND PREPARATION FOR PATIENTS WEIGHING ≥ 45 KG

In order to prepare BLINCYTO® solution for infusion for patients weighing at least 45 kg, you will need to know:

  • The prescribed dose

  • The infusion duration

It is very important that the instructions for preparation (including admixing) and administration provided in the full Prescribing Information are strictly followed to minimize medication errors (including underdose and overdose).

RECONSTITUTION OF BLINCYTO®
  1. Add 3 mL of preservative-free Sterile Water for Injection, USP by directing the water along the walls of the BLINCYTO® vial and not directly on the lyophilized powder (resulting in a final BLINCYTO® concentration of 12.5 mcg/mL).

    • Do not reconstitute BLINCYTO® with IV Solution Stabilizer (IVSS).

  1. Gently swirl the contents to avoid excess foaming. Do not shake.

  1. 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.

PREPARATION OF THE BLINCYTO® INFUSION BAG

Verify the prescribed dose and infusion duration for each BLINCYTO® infusion bag. To minimize errors, use the specific volumes described in the table below to prepare the BLINCYTO® infusion bag.

  1. Aseptically add 270 mL of 0.9% Sodium Chloride Injection, USP to the IV bag prior to the addition of IVSS and reconstituted BLINCYTO®.

    • Use only PVC DEHP-free, polyolefin or EVA IV bags/pump cassettes.

  1. Aseptically transfer 5.5 mL of IVSS to the IV bag containing 0.9% Sodium Chloride Injection, USP.

    • Gently mix the contents of the bag to avoid foaming. Discard the vial containing the unused IVSS.

FOR PATIENTS WEIGHING GREATER THAN OR EQUAL TO 45 KG: VOLUMES OF 0.9% SODIUM CHLORIDE INJECTION, USP, IVSS, AND RECONSTITUTED BLINCYTO® TO ADD TO IV BAG
Dose Infusion Duration Infusion Rate 0.9%
Sodium Chloride Injection, USP
IVSS Reconstituted
BLINCYTO®
9 mcg/day
24 hours 10 mL/hour 270 mL 5.5 mL 0.83 mL
48 hours 5 mL/hour 270 mL 5.5 mL 1.7 mL
28 mcg/day
24 hours 10 mL/hour 270 mL 5.5 mL 2.6 mL
48 hours 5 mL/hour 270 mL 5.5 mL 5.2 mL*
FOR PATIENTS WEIGHING GREATER THAN OR EQUAL TO 45 KG: VOLUMES OF 0.9% SODIUM CHLORIDE INJECTION, USP, IVSS, AND RECONSTITUTED BLINCYTO® TO ADD TO IV BAG
Dose 9 mcg/day
Infusion Duration 24 hours 48 hours
Infusion Rate 10 mL/hour 5 mL/hour
0.9% Sodium Chloride Injection, USP 270 mL 270 mL
IVSS 5.5 mL 5.5 mL
Reconstituted
BLINCYTO®
0.83 mL 1.7 mL
Dose 28 mcg/day
Infusion Duration 24 hours 48 hours
Infusion Rate 10 mL/hour 5 mL/hour
0.9% Sodium Chloride Injection, USP 270 mL 270 mL
IVSS 5.5 mL 5.5 mL
Reconstituted
BLINCYTO®
2.6 mL 5.2 mL
*Two packages of BLINCYTO® are needed for preparation of 28 mcg/day dose infused over 48 hours at a rate of 5 mL/hour.
  1. Aseptically transfer _mL of reconstituted BLINCYTO® into the IV bag containing 0.9% Sodium Chloride Injection, USP and IVSS.

    • Use the table above to determine the specific volume of reconstituted BLINCYTO® required for the prescribed dose and duration.

    • Gently mix the contents of the bag to avoid foaming.

  1. Under aseptic conditions, attach the IV tubing to the IV bag with the sterile 0.2 micron in-line filter.

    • Use only PVC DEHP-free, polyolefin or EVA IV tubing with a sterile, non-pyrogenic, low protein-binding 0.2 micron in-line filter.

    • Ensure that the IV tubing is compatible with the infusion pump.

  1. Remove air from the IV bag. This is particularly important for use with anambulatory infusion pump.

    • Prime the IV tubing only with the prepared solution for infusion. Do not prime with 0.9% Sodium Chloride Injection, USP.

  1. Store at 2°C to 8°C (36°F to 46°F) if not used immediately.

IMPORTANT NOTE: Do not flush the BLINCYTO® infusion line or IV catheter, especially when changing infusion bags. Flushing when changing bags or at completion of infusion can result in excess dosage and complications thereof. When administering via a multi-lumen venous catheter, BLINCYTO® should be infused through a dedicated lumen.

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Reference:
  1. BLINCYTO® (blinatumomab) Prescribing Information, Amgen.