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Blincyto

Blincyto

blinatumomab

Manufacturer:

Amgen

Distributor:

Zuellig Pharma

Marketer:

Amgen
Concise Prescribing Info
Contents
Blinatumomab
Indications/Uses
B-cell precursor acute lymphoblastic leukemia (ALL) in 1st or 2nd complete remission w/ minimal residual disease (MRD) ≥0.1% in adults & childn. Relapsed or refractory B-cell precursor ALL in adults & childn.
Dosage/Direction for Use
MRD-positive B-cell precursor ALL 1 cycle for induction followed by up to 3 additional cycles for consolidation. Single induction or consolidation cycle: 28 days of continuous IV infusion followed by 14 days treatment-free interval (total of 42 days). Patient weighing ≥45 kg Induction cycle 1 & consolidation cycles 2-4 (fixed-dose): 28 mcg/day on days 1-28; 14-day treatment-free interval on days 29-42. Patient weighing <45 kg Induction cycle 1 & consolidation cycles 2-4 (BSA-based dose): 15 mcg/m2/day (Max: 28 mcg/day) on days 1-28; 14-day treatment-free interval on days 29-42. Premed: Adult Prednisone 100 mg IV or equiv (eg, dexamethasone 16 mg) 1 hr prior to 1st dose in each cycle. Ped Dexamethasone 5 mg/m2 (Max dose: 20 mg) prior to 1st dose in 1st cycle & when restarting infusion after ≥4 hr interruption in 1st cycle. Relapsed or refractory B-cell precursor ALL 2 induction cycles followed by 3 additional cycles for consolidation & up to 4 additional cycles of continued therapy. Single induction or consolidation cycle: 28 days continuous IV infusion followed by 14 days treatment-free interval (total of 42 days). Single cycle of continued therapy: 28 days of continuous IV infusion followed by 56 days treatment-free interval (total of 84 days). Patient weighing ≥45 kg Induction cycle 1 (fixed-dose): 9 mcg/day on days 1-7; 28 mcg/day on days 8-28; 14-day treatment-free interval on days 29-42. Induction cycle 2 & consolidation cycles 3-5 (fixed dose): 28 mcg/day on days 1-28; 14-day treatment-free interval on days 29-42. Continued therapy cycles 6-9 (fixed dose): 28 mcg/day on days 1-28; 56-day treatment free interval on days 29-84. Patient weighing <45 kg Induction cycle 1 (BSA-based dose): 5 mcg/m2/day (Max: 9 mcg/day) on days 1-7; 15 mcg/m2/day (Max: 28 mcg/day) on days 8-28; 14-day treatment-free interval on days 29-42. Induction cycle 2 & consolidation cycles 3-5 (BSA-based dose): 15 mcg/m2/day (Max: 28 mcg/day) on days 1-28; 14-day treatment-free interval on days 29-42. Continued therapy cycles 6-9 (BSA-based dose): 15 mcg/m2/day (Max: 28 mcg/day) on days 1-28; 56-day treatment-free interval on days 29-84. Premed: Adult Dexamethasone 20 mg 1 hr prior to 1st dose of each cycle, prior to a step dose (eg, cycle 1 day 8) & when restarting an infusion after an interruption of ≥4 hr. Ped Dexamethasone 5 mg/m2 (Max dose: 20 mg) prior to 1st dose in the 1st cycle, prior to a step dose (eg, cycle 1 day 8), & when restarting an infusion after an interruption of ≥4 hr in the 1st cycle.
Contraindications
Special Precautions
Monitor for signs & symptoms of cytokine release syndrome (CRS), neurological toxicities, infections, tumor lysis syndrome (TLS), pancreatitis. Discontinue permanently in life-threatening CRS. Administer corticosteroids for severe or life-threatening CRS; antibiotics for serious infections; pretreatment nontoxic cytoreduction & on treatment hydration during treament for prevention of TLS. Interrupt or discontinue use if neurological toxicities or TLS occurs. Interrupt treatment if prolonged neutropenia occurs; if transaminases >5 x ULN or bilirubin >3 x ULN. Monitor laboratory parameters (eg, WBC & absolute neutrophil count) during infusion; alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-glutamyl transferase & total blood bilirubin prior to start of & during treatment. Leukoencephalopathy, especially in patients w/ prior treatment w/ cranial irradiation & antileukemic chemotherapy including systemic high-dose methotrexate or intrathecal cytarabine. Vaccination w/ live virus is not recommended for at least 2 wk prior to start of & during treatment, & until immune recovery following last cycle. Refrain from driving & engaging in hazardous occupations or activities eg, operating heavy or potentially dangerous machinery. Females of reproductive potential should use contraception during treatment & at least 48 hr after the last dose. Pregnancy. Do not breastfeed during & for at least 48 hr after treatment. Ped patients. Elderly.
Adverse Reactions
Neutropenia, leukopenia, thrombocytopenia, anemia; arrhythmia; pyrexia, chills, edema; cytokine release syndrome; unspecified pathogen infections, bacterial/viral/fungal infectious disorders; infusion-related reaction; decreased Ig, increased wt, hypertransaminasemia; back pain; headache, tremor, aphasia, dizziness, encephalopathy; insomnia; cough; rash; hypotension. Fatal pancreatitis.
Drug Interactions
Risk w/ CYP450 substrates, particularly those w/ a narrow therapeutic index.
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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