All the Active Ingredient Drugs
Monoclonal Antibody. Inotuzumab Ozogamicin 1 mg/vial. VIAL(pwdr. for concentrat. for sol. for infus.): 1. The drug should be admin. in 3- to 4-wk. cycles.
For pts. proceed. to haematopoietic stem cell transplant (HSCT), the recommend. duration of tmt. is 2 cycles. A 3rd cycle may be consid. for those pts. who do not achieve a complete remis. (CR) or complete remiss. with incomp. haematolog. recovery (CRi) and min. residual dis. (MRD) negative. after 2 cycles. For pts. not proceed. to HSCT, addit. cycles of tmt, up to a max. of 6 cycles, may be admin. Pts. who do not achieve a CR/CRi within 3 cycles should discont. tmt.
For the 1st t cycle, the recomm. total dose: Inotuzumab ozogamicin for all pts. is 1.8 mg/m² per cycle, given as 3 divid. doses on Days 1 (0.8 mg/m²), 8 (0.5 mg/m²), and 15 (0.5 mg/m²). Cycle 1 is 3 wks. in durat., but may be extend. to 4 wks. if the pt. achieves a CR or CRi, and/or to allow recovery from toxicity.
For subseq. cycles, the recomm. total dose: Inotuzumab ozogamicin is 1.5 mg/m² per cycle given as 3 divided doses on Days 1 (0.5 mg/m²), 8 (0.5 mg/m²), and 15 (0.5 mg/m²) for pts. who achieve a CR/CRi or 1.8 mg/m² per cycle given as 3 divided doses on Days 1 (0.8 mg/m²), 8 (0.5 mg/m²), and 15 (0.5 mg/m²) for pts. who do not achieve a CR/CRi. Subseq. cycles are 4 wks. in durat.
Dose modific. may be required based on individ. safety and tolerab. Manag. of some ADR's. See lit.
Indic. as monother. for the tmt. of adult. with relapsed or refract. CD22-posit. B cell precurs. acute lymphoblast. leuk. (ALL). Adult pts. with Philadelphia chromosome posit. (Ph+) relapsed or refract. B cell precursor ALL should have failed tmt. with at least 1 tyrosine kinase inhib.(TKI).
C/I: Hypersens. Pts. who have experienc. prior confirm. severe or ongoing venoocclusive hep. dis. /sinusoidal obstruct. syndr. (VOD/SOS). Pts. with serious ongoing hep. dis.e.g., cirrhosis, nodular regenerative hyperplasia, active hepatitis).
