Blincyto Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Blincyto Indications
Indications
Blincyto Dosage and Administration
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: premedicate 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: premedicate 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, using 24-hr, 48-hr, or 7-day infusion of Blincyto: see full labeling.
Other Modifications
Females and Males of Reproductive Potential
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May cause fetal harm when administered to a pregnant woman
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Pregnancy Testing: Verify the pregnancy status of females of reproductive potential prior to initiating treatment.
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Contraception: Advise females of reproductive potential to use effective contraception during treatment and for 48 hours after the last dose.
Blincyto Contraindications
Not Applicable
Blincyto Boxed Warnings
Boxed Warning
Blincyto Warnings/Precautions
Warnings/Precautions
REMS
Blincyto Pharmacokinetics
Distribution
The estimated mean (SD) volume of distribution based on terminal phase (Vz) was 4.35 (2.45) L with continuous intravenous infusion of blinatumomab.
Elimination
The estimated mean (SD) systemic clearance with continuous intravenous infusion in patients receiving blinatumomab in clinical studies was 3.11 (2.98) L/hour. The mean (SD) half-life was 2.10 (1.41) hours. Negligible amounts of blinatumomab were excreted in the urine at the tested clinical doses.
Blincyto Interactions
Interactions
Blincyto Adverse Reactions
Adverse Reactions
Blincyto Clinical Trials
Blincyto Note
Not Applicable
Blincyto Patient Counseling
Cost Savings Program
Blincyto Support and Resources: https://www.blincyto.com/relapsed-refractory/support-and-resources