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 calculat. 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).
MRD positive B-precursor ALL for Philadelphia chromosome negat.: Pts. may receive 1 cycle of induct. tmt. follow. by up to 3 addit. cycles of consolidation tmt. A single cycle of tmt. induct. or consolidation is 28 d. (4 wks.) of contin. IV infus. follow. by a 14 d. (2 wk.) tmt. -free interv. (total 42 d.). The majority of pts. who respond to blinatumomab
achieve a response after 1 cycle. Therefore, the potent. benefit and risks assoc. with contin. ther. in pts. who do not show haematolog. and/or clinical improve. after 1 tmt. cycle should be assessed by the treating physician. 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 adults with Philadelphia chromosome neg. CD19 positive B-precursor ALL in first or second complete remiss. with minimal residual dis. (MRD) greater than or equal to 0.1%.
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.