INDICATIONS AND USAGE（适应症）

MRD-positive B-cell Precursor ALL

BLINCYTO is indicated for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children.

This indication is approved under accelerated approval based on MRD response rate and hematological relapse-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Relapsed or Refractory B-cell Precursor ALL

BLINCYTO is indicated for the treatment of relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.

DOSAGE（服用剂量）

Treatment of MRD-positive B-cell Precursor ALL

A treatment course consists of 1 cycle of BLINCYTO for induction followed by up to 3 additional cycles for consolidation.

A single cycle of treatment of BLINCYTO induction or consolidation consists of 28 days of continuous intravenous infusion followed by a 14-day treatment-free interval (total 42 days).

Patients weighing 45 kg or more receive a fixed-dose. For patients weighing less than 45 kg, the dose is calculated using the patient's body surface area (BSA).

Hospitalization is recommended for the first 3 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiations (e.g., if treatment is interrupted for 4 or more hours), supervision by a healthcare professional or hospitalization is recommended.

Premedicate with prednisone or equivalent for MRD-positive B-cell Precursor ALL

For adult patients, premedicate with prednisone 100 mg intravenously or equivalent (e.g., dexamethasone 16 mg) 1 hour prior to the first dose of BLINCYTO in each cycle.

For pediatric patients, premedicate with 5 mg/m2 of dexamethasone, to a maximum dose of 20 mg, prior to the first dose of BLINCYTO in the first cycle and when restarting an infusion after an interruption of 4 or more hours in the first cycle.

Treatment of Relapsed or Refractory B-cell Precursor ALL

A treatment course consists of up to 2 cycles of BLINCYTO for induction followed by 3 additional cycles for consolidation and up to 4 additional cycles of continued therapy.

A single cycle of treatment of BLINCYTO induction or consolidation consists of 28 days of continuous intravenous infusion followed by a 14-day treatment-free interval (total 42 days).

A single cycle of treatment of BLINCYTO continued therapy consists of 28 days of continuous intravenous infusion followed by a 56-day treatment-free interval (total 84 days).

Patients weighing 45 kg or more receive a fixed-dose and for patients weighing less than 45 kg, the dose is calculated using the patient's BSA.

Hospitalization is recommended for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g., if treatment is interrupted for 4 or more hours), supervision by a healthcare professional or hospitalization is recommended.

Premedicate with dexamethasone:

For adult patients, premedicate with 20 mg of dexamethasone 1 hour prior to the first dose of BLINCYTO of each cycle, prior to a step dose (such as Cycle 1 Day 8), and when restarting an infusion after an interruption of 4 or more hours.

For pediatric patients, premedicate with 5 mg/m2 of dexamethasone, to a maximum dose of 20 mg, prior to the first dose of BLINCYTO in the first cycle, prior to a step dose (such as Cycle 1 Day 8), and when restarting an infusion after an interruption of 4 or more hours in the first cycle.

ADVERSE REACTIONS（不良反应）

Cytokine Release Syndrome

Neurological Toxicities

Infections

Tumor Lysis Syndrome

Neutropenia and Febrile Neutropenia

Effects on Ability to Drive and Use Machines

Elevated Liver Enzymes

Pancreatitis

Leukoencephalopathy

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/38b482a8-960b-4591-9857-5031ecb830aa/spl-doc?hl=Blincyto

Blincytoinformation