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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
PACKAGE CONTENTS AND STORAGE
BLINCYTO® (blinatumomab) PACKAGE CONTENTS AND VIALS
BLINCYTO® (blinatumomab) Package Contents and Vials
Package and vials are not shown to scale
Each BLINCYTO® package contains1:
  • One BLINCYTO® 35 mcg single-dose vial containing a sterile, preservative free, white to off-white lyophilized powder

  • One IV Solution Stabilizer 10 mL single-dose glass vial containing a sterile, preservative free, colorless-to-slightly yellow, clear solution

    • The IVSS is injected into the IV bag prior to the addition of reconstituted BLINCYTO® to prevent adhesion of BLINCYTO® to the IV bags and IV tubing.

    • Do not use the IV Solution Stabilizer to reconstitute BLINCYTO®

NOTE:

The package does not include preservative-free Sterile Water for Injection, USP, which should be used to reconstitute the lyophilized BLINCYTO® powder.

Please see full Prescribing Information for complete reconstitution and preparation instructions.

STORAGE AND HANDLING OF BLINCYTO® AND IV SOLUTION
STABILIZER (IVSS) VIALS
BLINCYTO® (blinatumomab) Storage Instructions

Refrigerate at 2°C to 8°C (36°F to 46°F) in the original packaging.1

BLINCYTO® (blinatumomab) Storage Instructions

Do not freeze.1

BLINCYTO® (blinatumomab) Storage Instructions

Protect the vials of
BLINCYTO® and IVSS
from light until time
of use.1



Please see full Prescribing Information for complete Storage and Handling requirements, including those for reconstituted BLINCYTO® and IV Solution Stabilizer.

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