Inotuzumab
Class: Antineoplastic Agents
- ADCs
- Antibody-drug Conjugates
Chemical Name: Immunoglobulin G4 (anti-(human CD22 (antigen)) (human-mouse monoclonal G544 heavy chain), disulfide with human-mouse monoclonal G544 κ-chain, dimer, methyl [(1R,4Z,8S,13E)-8-[[2-O-[4-(acetylethylamino)-2,4-dideoxy-3-O-methyl-α-l-threo-pentopyranosyl]-4,6-dideoxy-4-[[[2,6-dideoxy-4-S-[4-[(6-deoxy-3-O-methyl-α-l-mannopyranosyl)oxy]-3-iodo-5,6-dimethoxy-2-methylbenzoyl]-4-thio-β-d-ribo-hexopyranosyl]oxy]amino]-β-d-glucopyranosyl]oxy]-13-[2-[[3-[[1-[4-(4-amino-4-oxobutoxy)phenyl]ethylidene]hydrazino]-1,1-dimethyl-3-oxopropyl]dithio]ethylidene]-1-hydroxy-11-oxobicyclo[7.3.1]trideca-4,9-diene-2,6-diyn-10-yl]carbamate conjugate
Molecular Formula: C6518H10002N1738O2036S42
CAS Number: 635715-01-4
Brands: Besponsa
Warning
- Hepatotoxicity, including Hepatic Veno-occlusive Disease (VOD)
Hepatotoxicity, including fatal and life-threatening hepatic VOD (also known as sinusoidal obstruction syndrome), occurred in patients with relapsed or refractory acute lymphoblastic leukemia (ALL) treated with inotuzumab ozogamicin.
Elevated liver function values may necessitate interruption of therapy, dosage reduction, or permanent discontinuance of inotuzumab ozogamicin.
If hepatic VOD occurs, permanently discontinue drug.
If severe hepatic VOD occurs, treat according to standard medical practice. (See Hepatotoxicity under Dosage and Administration and also see Hepatotoxicity, including Hepatic VOD, under Cautions.)
- Increased Risk of Post-HSCT Non-relapse Mortality
Patients receiving inotuzumab ozogamicin had a higher post-HSCT non-relapse mortality rate, which resulted in a higher day 100 post-HSCT mortality rate. (See Increased Risk of Post-transplant Non-relapse Mortality under Cautions.)
Introduction
Antineoplastic agent; a CD22-directed antibody-drug conjugate consisting of a recombinant humanized IgG4 kappa monoclonal antibody (inotuzumab) covalently linked to a cytotoxic calicheamicin derivative (N-acetyl-γ-calicheamicin).
Uses for Inotuzumab
B-Cell Precursor Acute Lymphoblastic Leukemia
Treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (pre-B-ALL) (designated an orphan drug by FDA for treatment of pre-B-ALL).
Efficacy determined based on complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) in an open-label, randomized phase 3 study (INO-VATE ALL) in patients with relapsed or refractory pre-B-ALL.
Inotuzumab Dosage and Administration
General
To minimize risk of infusion-related reactions, premedicate with a corticosteroid, antipyretic, and antihistamine prior to each inotuzumab ozogamicin infusion. Observe patients for symptoms of infusion-related reactions during and for ≥1 hour after end of each infusion. (See Infusion-related Reactions under Cautions.)
If patient has circula
