Blincyto

Blincyto

blinatumomab

Manufacturer:

Amgen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Blinatumomab
Indications/Uses
Minimal residual disease (MRD) +ve, 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 14-day treatment-free interval. MRD +ve B-cell precursor ALL Patient ≥45 kg Cycle 1 (fixed-dose): 28 mcg daily on days 1-28. Consolidation cycles 2-4: 28 mcg daily on days 1-28. Premed Adult Prednisolone 100 mg IV or equiv 1 hr prior to 1st dose in each cycle. Relapse or refractory B-cell precursor ALL Patient ≥45 kg Cycle 1 (fixed-dose): Initially 9 mcg daily on days 1-7 then 28 mcg daily on days 8-28. Cycle 2: 28 mcg daily for days 1-28. Consolidation cycles 3-5: 28 mcg daily on days 1-28. Continued therapy cycles 6-9: 28 mcg daily for days 1-28 followed by 56-day treatment-free interval. Patient <45 kg Cycle 1 (BSA-based dose): Initially 5 mcg/m2 daily (not to exceed 9 mcg daily) on days 1-7 then 15 mcg/m2 daily (not to exceed 28 mcg daily) on days 8-28. Cycle 2: 15 mcg/m2 daily (not to exceed 28 mcg daily) for days 1-28. Consolidation cycles 3-5: 15 mcg/m2 daily (not to exceed 28 mcg daily) on days 1-28. Continued therapy cycles 6-9: 28 mcg daily for days 1-28 followed by 56-day treatment-free interval. Premed Adult Dexamethasone 20 mg 1 hr prior to 1st dose of each cycle prior to step dose (eg, cycle 1 day 8) & when restarting after ≥4 hr interruption. Ped Dexamethasone 5 mg/m2 up to max: 20 mg prior to 1st dose in 1st cycle prior to step dose (eg, cycle 1 day 8) & when restarting after ≥4 hr interruption in 1st cycle.
Contraindications
Special Precautions
Monitor for signs & symptoms of cytokine release syndrome (CRS), neurological toxicities, infections & tumor lysis syndrome. History or presence of clinically relevant CNS pathology; neutropenia & febrile neutropenia; pancreatitis; leukoencephalopathy. Monitor lab parameters eg, WBC & ANC; ALT, AST, γ-glutamyl transferase & total bilirubin prior to & during treatment. Immunogenicity. Not recommended w/ live virus vaccines for at least 2 wk prior to, during & until immune recovery following last cycle. May affect ability to drive & use machines. Females of reproductive potential should use effective contraception during & at least 48 hr after last dose. Pregnancy. Not to be used during lactation & at least 48 hr after last dose. Ped patients. Elderly.
Adverse Reactions
Pyrexia, infusion-related reactions, headache, infections, neutropenia, overdose, device-related infection. MRD +ve B-cell precursor ALL: Tremor, chills; encephalopathy, aphasia, lymphopenia, seizure, staphylococcal infection. Relapsed or refractory B-cell precursor ALL: Anemia, febrile neutropenia, thrombocytopenia; sepsis, pneumonia, septic shock, CRS, bacterial sepsis, bacteremia.
Drug Interactions
Monitor for toxicity (eg, warfarin) or drug conc (eg, cyclosporine) w/ CYP450 substrates.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01FX07 - blinatumomab ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.
Presentation/Packing
Form
Blincyto powd for infusion 35 mcg
Packing/Price
((single-dose)) 1's
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