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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® 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 4 weeks of continuous BLINCYTO® infusion, followed by a 2-week 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
For patients ≥ 45 kg (99 lbs) in weight
BLINCYTO® (blinatumomab) Dosage and Treatment Cycles BLINCYTO® (blinatumomab) Dosage and Treatment Cycles
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 especially when changing infusion bags. Flushing when changing bags or at completion of infusion can result in excess dosage. BLINCYTO® should be infused through a dedicated lumen.1

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

CYCLE 1
Starting Dose

The recommended initial dose of BLINCYTO® in the first cycle is 9 mcg/day for week 1 (first 7 days) of treatment.1

Dose Increase

Increase the dose to 28 mcg/day starting at week 2 through week 4 of the first cycle.1

Treatment-Free Intervals

Allow for at least 2 weeks treatment-free between cycles of BLINCYTO®.1

CYCLES 2-5

All subsequent cycles should be dosed at 28 mcg/day throughout the entire 4-week treatment period. Allow for at least 2 weeks treatment-free between cycles of BLINCYTO®.1

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