BLINCYTO(BLINATUMOMAB)INJECTABLE;INJECTION 治疗急性淋巴膜细胞白血病一种的罕见形式
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use BLINCYTOTM safely and effectively.  See full prescribing information for BLINCYTO. 
BLINCYTO (blinatumomab) for injection, for intravenous use
Initial U.S. Approval: 2014
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES
See full prescribing information for complete boxed warning.
Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO as recommended. (2.3), (5.1)
Neurological toxicities, which may be severe, life-threatening, or fatal, occurred in patients receiving BLINCYTO. Interrupt or discontinue BLINCYTO as recommended. (2.3), (5.2)
INDICATIONS AND USAGE
BLINCYTO is a bispecific CD19-directed CD3 T-cell engager 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. (1)
DOSAGE AND ADMINISTRATION
Dosage
    -  Hospitalization is recommended for the first 9 days of the first cycle and the first 2 days of the second cycle. (2)
    -  A single cycle of treatment consists of 4 weeks of continuous intravenous infusion followed by a 2-week treatment-free interval. (2.1)
    -  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 at 28 mcg/day on Days 1–28. (2.1)
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. (2.2)
    -  Administer as a continuous intravenous infusion at a constant flow rate using an infusion pump. (2.2)
    -  The IV bag should be infused over 24 hours or 48 hours. (2.2)
    -  BLINCYTO should be infused through a dedicated lumen. (2.2)
Preparation
    -  IV Solution Stabilizer is provided and is used to coat the prefilled IV bag prior to addition of reconstituted BLINCYTO. (2.4)
    -  Reconstitute BLINCYTO with Sterile Water for Injection, USP, only. (2.4)
    -  Aseptic technique must be strictly observed when preparing the solution for infusion since BLINCYTO does not contain antimicrobial preservatives. (2.4)
    -  Use the specific volumes described in the admixing instructions. (2.4)
DOSAGE FORMS AND STRENGTHS
For injection: 35 mcg of lyophilized powder in a single-use vial for reconstitution. (3)
CONTRAINDICATIONS
Known hypersensitivity to blinatumomab or to any component of the product formulation. (4)
WARNINGS AND PRECAUTIONS
Infections: Monitor patients for signs or symptoms and treat appropriately. (5.3)
Effects on Ability to Drive and Use Machines: Advise patients to refrain from driving and en