Blinatumomab

1 Drug classified under this active ingredient

Monoclonal Antibody. Blinatumomab 12.5 mcg/ml.
VIAL (concentr. 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, dose is calc. using the pt’s. body surface area. (BSA).
Recommen. dose for adult pts. at least 45 kg in wt. (fixed-dose): 1^st 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).
2^nd 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. (do not exceed 9 mcg/day).
Days 8-28: 15 mcg/m²/d via contin.  infus. (do not exceed 28 mcg/d).
Subseq. Cycle Days 1-28: 15 mcg/m²/d via contin. infus. (do not exceed 28 mcg/d).
MRD posit. B-precursor ALL for Philadelphia chrom. negat.: pts. may receive 1 cycle of induct. tmt. follow. by up to 3 addit. cycles of consol. tmt. A sgle. cycle of tmt. induct. or consol. is 28 d. (4 wks.) of contin. IV infus. follow. by a 14 d. (2 wk.) tmt. -free interv. (total 42 d.). The major. of pts. who resp. to blinatumomab achieve a resp. aft. 1 cycle. Therefore, the potent. benefit and risks assoc. with contin. ther. in pts. who do not show haematolog. and/or clinic. improv. after 1 tmt. cycle should be assessed by treat. phys. See lit.

Monother. tmt. for adlts with CD19 posit. relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL). Pats with Philadelphia chromosome posit. B-precursor ALL should have failed tmt. with at least 2 tyrosine kinase inhib. (TKIs) and have no alternative tmt. options.

Monother. tmt. for adlts with Philadelphia chromosome negat. CD19 posit B-precursor ALL in first or second complete remission with minim. residual dis. (MRD) greater than or equal to 0.1%.

Monother. tmt. for ped. pats aged 1 year or older with Philadelphia chromosome neg. CD19 posit. B-precursor ALL which is refractory or in relapse after receiving at least two prior ther. or in relapse after receiving prior allogeneic hematopoietic stem cell transplant. Limitat. of use: After failure of two previous tmts. and with no CNS involvement.

Tmt. of CD19-posit. Philadelphia chromosome-negat. B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemother. in adult and ped. pts one month and older. Limitat. of use: with no CNS involvement.
C/I: Hypersens. Breastfeeding.