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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
DOSAGE AND TREATMENT CYCLES
BLINCYTO® (blinatumomab) IS ADMINISTERED AS A CONTINUOUS INTRAVENOUS INFUSION1 BLINCYTO® (blinatumomab)
IS ADMINISTERED
AS A CONTINUOUS
INTRAVENOUS INFUSION1

BLINCYTO® must be administered as a continuous intravenous infusion, delivered at a constant flow rate using an infusion pump. The infusion pump should be programmable, lockable, non-elastomeric, and have an alarm.1

In each treatment cycle, patients receive 28-day continuous BLINCYTO® infusion, followed by a 14-day treatment-free period. Patients may receive 2 cycles of induction treatment followed by 3 additional cycles of BLINCYTO® consolidation treatment (up to a total of 5 cycles).1

TREATMENT CYCLES1
Fixed Dosing for Patients Weighing ≥ 45 kg
BLINCYTO® (blinatumomab) Dosage and Treatment Cycles BLINCYTO® (blinatumomab) Dosage and Treatment Cycles

 

BSA-Based Dosing for Patients Weighing < 45 kg
BSA-Based Dosing for Patients Weighing under 45 kg BSA-Based Dosing for Patients Weighing under 45 kg
BSA, body surface area
Patients who achieved CR within 2 cycles of induction therapy were allowed to receive up to 3 additional cycles of consolidation therapy.
Hospitalization is recommended for the first 9 days of the first cycle and the first 2 days of the second cycle.1

For all subsequent cycle starts and reinitiation (eg, if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalization is recommended.1

IMPORTANT NOTE: Do not flush the BLINCYTO® infusion line or intravenous 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.

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).1

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