BLINCYTO 35 MCG/VIAL

BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory Bcell 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.

Dosage

Hospitalization is recommended for the first 9 days of the first cycle and the first 2 days of the second cycle.
A single cycle of treatment consists of 4 weeks of continuous intravenous infusion followed by a 2-week treatment-free interval.
For patients at least 45 kg in weight, in Cycle 1, administer BLINCYTO at 9 mcg/day on Days 1–7 and at 28 mcg/day on Days 8–28. For subsequent cycles, administer BLINCYTO at28 mcg/day on Days 1–28.

Administration

Premedicate with dexamethasone 20 mg intravenously 1 hour prior to the first dose of BLINCYTO of each cycle, prior to a step dose (such as Cycle 1 day 8), or when restarting an infusion after an interruption of 4 or more hours.
Administer as a continuous intravenous infusion at a constant flow rate using an infusion pump.

Each BLINCYTO package (NDC 55513-160-01) contains.

One BLINCYTO 35 mcg single-use vial containing a sterile, preservative-free, white to off-white lyophilized powder and

One IV Solution Stabilizer 10 mL single-use glass vial containing a sterile, preservative-free, colorless to slightly yellow, clear solution. Do not use the IV Solution Stabilizer to reconstitute BLINCYTO.

BLINCYTO is a prescription medicine used to treat a certain type of acute lymphoblastic leukemia (ALL). Acute lymphoblastic leukemia is a cancer of the blood in which a particular kind of white blood cell is growing out of control. There is limited experience in using BLINCYTO in children.