Generic Name and Formulations:
Blinatumomab 35mcg; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
Indications for BLINCYTO:
B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) ≥0.1%. Relapsed or refractory B-cell precursor ALL.
Adults and Children:
Strictly follow preparation and administration instructions. Give by continuous IV infusion at a rate of 10mL/hr over 24hrs, 5mL/hr over 48hrs, or 0.6mL/hr over 7 days (not recommended for patients <22kg). MRD-positive: pre-medicate with prednisone 100mg IV or equivalent (adults) 1hr prior to 1st dose of each cycle, or dexamethasone 5mg/m2 to max 20mg (pediatrics) prior to 1st dose in the 1st cycle, and when restarting infusion after interruption (≥4hrs). Treat up to 4 cycles (1 cycle for induction, followed by 3 cycles for consolidation). One single cycle = 28 days of continuous IV infusion followed by a 14-day treatment-free interval (during Cycles 1–4). Hospitalization recommended for first 3 days of Cycle 1 and first 2 days of Cycle 2. <45kg (Cycles 1–4): 15mcg/m2/day (max 28mcg/day) on Days 1–28. ≥45kg (Cycles 1–4): 28mcg/day on Days 1–28. Relapsed/refractory: pre-medicate with dexamethasone 20mg (adults) 1hr prior to 1st dose of each cycle, or dexamethasone 5mg/m2 to max 20mg (pediatrics) prior to 1st dose in the 1st cycle, plus prior to a step dose, and when restarting infusion after interruption (≥4hrs) for both adults and pediatrics. Treat up to 9 cycles (2 cycles for induction, followed by 3 cycles for consolidation, and up to 4 additional cycles of continued therapy). One single cycle = 28 days of continuous IV infusion followed by a 14-day treatment-free interval (during Cycles 1–5) and 56-day treatment-free interval (during Cycles 6–9). Hospitalization recommended for first 9 days of Cycle 1 and first 2 days of Cycle 2. <45kg (Cycle 1): 5mcg/m2/day (max 9mcg/day) on Days 1–7 and 15mcg/m2/day (max 28mcg/day) on Days 8–28; (Cycles 2–9): 15mcg/m2/day (max 28mcg/day) on Days 1–28. ≥45kg (Cycle 1): 9mcg/day on Days 1–7 and 28mcg/day on Days 8–28; (Cycles 2–9): 28mcg/day on Days 1–28. Dose adjustments or using 7-day infusion of Blincyto (with preservative): see full labeling.
Cytokine release syndrome. Neurological toxicities.
Monitor for cytokine release syndrome or neurological toxicities; interrupt or discontinue as recommended (see full labeling). Monitor for infections; give antibiotic prophylaxis as appropriate. Monitor for tumor lysis syndrome; interrupt or discontinue as needed. Obtain lab tests (including WBC, ANC) during infusion; interrupt if prolonged neutropenia occurs. Monitor ALT, AST, GGT, and total bilirubin prior to and during treatment; interrupt if transaminases rise >5XULN or if bilirubin rises >3XULN. Evaluate if signs/symptoms of pancreatitis develop; interrupt or discontinue as appropriate. Risk of leukoencephalopathy, esp. in those with prior treatment with cranial irradiation and antileukemic chemotherapy (including high-dose methotrexate or intrathecal cytarabine). Elderly. Neonates/infants: risk of gasping syndrome (due to benzyl alcohol preservative). Pregnancy; verify status prior to initiation. Females of reproductive potential should use effective contraception during and for at least 48hrs after last dose. Nursing mothers: not recommended (during and for at least 48hrs after last dose).
Bispecific CD19-directed CD3 T-cell engager.
Concomitant live vaccines: not recommended (for at least 2 weeks prior to initiation, during treatment, and until immune recovery after last cycle). Caution with concomitant CYP450 substrates esp. drugs with narrow therapeutic index (eg, warfarin, cyclosporine); monitor and adjust dose as needed.
Infections, pyrexia, headache, infusion-related reactions, anemia, febrile neutropenia, thrombocytopenia, neutropenia.
Pack—1 (single-use vial + IV solution stabilizer)