All the Active Ingredient Drugs
Monoclonal Antibody. Blinatumomab 12.5 mcg/ml. VIAL (concent. for sol. for infus.+ stabilizer sol. for infus.): 1×35mcg. Recommen. dly. dose is by pt. wt. Pts. greater than or equal to 45 kg receive a fixed-dose and for pts. less than 45 kg, the dose is calculate. using the pt’s. body surface area. (BSA).
Recommen. dose for adult pts. at least 45 kg in wt. (fixed-dose): 1st Cycle: Start. dose Days 1–7: 9 mcg/d via cont. infus.
Subseq. dose Days 8–28: 28 mcg/d via cont. infus. 2 week-tmt. free interval (Days 29 – 42).
2nd cycle & subseq. cycles (Days 1 – 28): 28 mcg/d via cont. infus.
Pts. Less than 45 kg (BSA-based dose): Days 1-7; 5 mcg/m²/day via cont. infus. Days 8-28: (not to exceed 9 mcg/day). Days 8-28 :15 mcg/m²/d via contin. infus. (not to exceed 28 mcg/d).
Days 1-28: 15 mcg/m²/d via contin. infus. (not to exceed 28 mcg/d). See lit.
Indicated as monother. for the tmt. of adults with Philadelphia chromosome neg. CD19 posit. relapsed or refract. B-precursor acute lymphoblast. leukemia (ALL).
Indicated as monother. for the tmt. of pediatr. pts. aged 1 year or older with Philadelphia chromosome neg. CD19 posit. B-cell precursor ALL which is refract. or in relapse after receiv. at least two prior therapies or in relapse after receiv. prior allogeneic hematopoiet. stem cell transplantat.
Limitations of use: After failure of two previous tmts. and with no CNS involvem.
C/I: Hyperses, lact.