Blincyto

Blincyto

blinatumomab

Manufacturer:

Amgen

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Blinatumomab
Indications/Uses
Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Dosage/Direction for Use
Single cycle treatment: Continuous IV infusion for 28 days followed by a 14-day treatment-free interval. Patient ≥45 kg Cycle 1: 9 mcg/day on days 1-7; 28 mcg/day on days 8-28. Allow a 14-day treatment-free between cycles. Subsequent cycles: 28 mcg/day on days 1-28, followed by a 14-day treatment-free interval on days 29-42. <45 kg (BSA-based dose) Cycle 1: 5 mcg/m2/day (not to exceed 9 mcg/day) on days 1-7; 15 mcg/m2/day (not to exceed 28 mcg/day) on days 8-28. Allow a 14-day treatment-free between cycles. Subsequent cycles: 15 mcg/m2/day (not to exceed 28 mcg/day) on days 1-28. Allow 14-day treatment-free interval on days 29-42. A treatment course consists of up to 2 cycles of Blincyto for induction followed by 3 additional cycles for consolidation treatment (up to a total of 5 cycles). Adult Premed w/ dexamethasone 20 mg 1 hr prior to 1st dose of each cycle, prior to step dose (eg, cycle 1 day 8), & when restarting an infusion after an interruption of ≥4 hr. Ped patient Premed w/ dexamethasone 5 mg/m2 to a max dose of 20 mg prior to 1st dose of Blincyto (cycle 1), prior to step dose (eg, cycle 1 day 8), & when restarting an infusion after an interruption of ≥4 hr in the 1st cycle.
Contraindications
Special Precautions
Discontinue use if serious adverse events that may be associated w/ cytokine release syndrome occurs. Monitor patients for signs & symptoms of neurological toxicities & interrupt or discontinue treatment as recommended. Monitor patients for signs & symptoms of infection, tumor lysis syndrome, or pancreatitis. Cases of neutropenia & febrile neutropenia have been observed. Interrupt treatment if prolonged neutropenia occurs. Monitor ALT, AST, γ-glutamyl transferase & total blood bilirubin prior to the start of & during treatment. Interrupt treatment if transaminases rise to >5 x ULN or if bilirubin rises to >3 x ULN. Cranial MRI changes showing leukoencephalopathy have been observed. Not recommended for vaccination w/ live virus vaccine for at least 2 wk prior to start of treatment, during treatment, & until immune recovery following the last cycle. May affect ability to drive & use machines. Pregnancy & lactation. Elderly ≥65 yr.
Adverse Reactions
Pyrexia, headache, nausea, edema, hypokalemia, anemia, febrile neutropenia, neutropenia, thrombocytopenia, abdominal pain.
Drug Interactions
Risk of drug-drug interaction during the 1st 9 days of the 1st cycle & 1st 2 days of the 2nd cycle in concomitant w/ CYP450 substrates.
ATC Classification
L01XC19 - blinatumomab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Blincyto powd for infusion 35 mcg
Packing/Price
1's
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