Identification

Name
Inotuzumab ozogamicin
Accession Number
DB05889
Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Monoclonal antibody (mAb)
Description

Inotuzumab ozogamicin is an antibody-drug conjugate using linker and cytotoxic drug technology similar to that developed for the ground-breaking treatment Mylotarg (Gemtuzumab ozogamicin), which was approved by the US FDA in 2000 for the treatment of acute myeloid leukaemia. Inotuzumab ozogamicin consists of a recombinant humanised IgG4 kappa CD22-targeting monoclonal antibody covalently attached to calicheamicin derivative, N-acetyl-gamma-calicheamicin dimethylhydrazide, which is a potent DNA-binding cytotoxic agent [4]. Developed by Pfizer and UCB, inotuzumab ozogamicin was granted approval by EU in June 2017 followed by FDA on August 17th, 2017 for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). ALL is a rapidly progressing cancer of the bone marrow that is associated with high mortality rates and low therapeutic response from standard chemotherapies in relasping conditions. In a randomized trial, inotuzumab ozogamicin displayed higher percentages of patients undergoing longer periods of complete remission with no evidence of disease in comparison to patients receiving alternative chemotherapy [5].

Protein structure
Db05889
Protein chemical formula
Not Available
Protein average weight
Not Available
Sequences
Not Available
Synonyms
  • CMC 544
  • WAY-207294
External IDs
CMC-544 / PF-05208773 / WAY-207294
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
BesponsaInjection, powder, lyophilized, for solution.25 mg/mLIntravenousWyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.2017-08-18Not applicableUs
Categories
UNII
P93RUU11P7
CAS number
635715-01-4

Pharmacology

Indication

Indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL).

Structured Indications
Not Available
Pharmacodynamics

Inotuzumab ozogamicin is an antineoplastic agent that targets CD22 antigen expressed on immature B-cell lymphocytes and blocks further growth of tumor cells. The drug aims to restore normal blood counts and achieve complete remission from the disease. QT interval prolongation was observed in patients receiving inotuzumab ozogamicin.

Mechanism of action

Inotuzumab ozogamicin is comprised of cytotoxic antibiotic N-acetyl-gamma-calicheamicin dimethylhydrazide attached to a humanized monoclonal IgG4 antibody via 4-(4 acetylphenoxy) butanoic acid (acetyl butyrate) linker. The drug exerts a potent cytotoxic effect against CD22+ B-cell lymphoma when the antibody binds to the CD22 receptor on the surface of B cells . The drug-CD22 complex is rapidly internalized into the cell, forming an endosome which subsequently fuses with lysosomes. N-acetyl-gamma-calicheamicin dimethylhydrazide is then intracellularly released into the acidic environment. N-acetyl-gamma-calicheamicin dimethylhydrazide is a calicheamicin derivative, which is naturally produced by the bacterium Micromonospora echinospora, and is toxic to the body when not bound to the antibody. It mediates apoptosis of the cell by binding to the minor groove of DNA in a sequence-specific manner and undergoing a structural change to generate diradicals [A20354]. These changes abstract hydrogen ions from the phosphodiester bonds of double-stranded DNA, resulting in breaks and cell apoptosis [1, 2, 4].

TargetActionsOrganism
AB-cell receptor CD22
antibody
Human
Absorption

Inotuzumab ozogamicin is intended to be administered in cycles that each run for 3 to 4 weeks. The steady state exposure of the drug is reached by Cycle 4. The mean (SD) maximum serum concentration (Cmax) of inotuzumab ozogamicin was 308 ng/mL (362) with patients receving the recommended dose of 1.8 mg/m^2/cycle [6].

Volume of distribution

The total volume of distribution of inotuzumab ozogamicin is approximately 12L [6].

Protein binding

In vitro studies show the binding of the N-acetyl-gamma-calicheamicin dimethylhydrazide to human plasma proteins to be approximately 97% [6].

Metabolism

N-acetyl-gamma-calicheamicin dimethylhydrazide primarily undergoes nonenzymatic reduction in vitro. The metabolism of N-acetyl-gamma-calicheamicin dimethylhydrazide in human serum is not clearly understood as the level of the drug is below the limit of quantification of 50 pg/mL [6]. The antibody portion of the drug is thought to undergo proteolytic degradation into amino acids then recycled into other proteins [3].

Route of elimination

The drug is disposited in the body after administration.

Half life

The elimination half life at the end of Cycle 4 of administration is approximately 12.3 days in a 2-compartment model [6].

Clearance

The clearance of inotuzumab ozogamicin at steady state is 0.0333 L/h [6].

Toxicity

Inotuzumab ozogamicin was shown to be clastogenic in vivo in the bone marrow of male mice but was not mutagenic in an* in vitro* bacterial reverse mutation (Ames) assay. In rat toxicity studies, rats developed oval cell hyperplasia, altered hepatocellular foci, and hepatocellular adenomas however the carcinogenic potential of inotuzumab ozogamicin on humans is undetermined. Based on reproductive toxicity studies involving female rats and non-clinical studies, inotuzumab ozogamicin has the potential to impair reproductive function and fertility in men and women [6].

Affected organisms
  • Humans and other mammals
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
DrugInteractionDrug group
AcetaminophenThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Acetaminophen.Approved
AfatinibThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Afatinib.Approved
AlbendazoleThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Albendazole.Approved, Vet Approved
AldosteroneThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Aldosterone.Experimental
AlectinibThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Alectinib.Approved
AlfentanilThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Alfentanil.Approved, Illicit
AmantadineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Amantadine.Approved
Aminohippuric acidThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Aminohippuric acid.Approved
AmiodaroneThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Amiodarone.Approved, Investigational
AmitriptylineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Amitriptyline.Approved
AmlodipineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Amlodipine.Approved
AmprenavirThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Amprenavir.Approved
AmsacrineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Amsacrine.Approved
AstemizoleThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Astemizole.Approved, Withdrawn
AtazanavirThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Atazanavir.Approved, Investigational
AtenololThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Atenolol.Approved
AtorvastatinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Atorvastatin.Approved
AzelastineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Azelastine.Approved
AzithromycinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Azithromycin.Approved
BCG vaccineThe therapeutic efficacy of BCG vaccine can be decreased when used in combination with Inotuzumab ozogamicin.Investigational
BelimumabThe risk or severity of adverse effects can be increased when Inotuzumab ozogamicin is combined with Belimumab.Approved
BenzocaineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Benzocaine.Approved
BepridilThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Bepridil.Approved, Withdrawn
BiperidenThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Biperiden.Approved
BoceprevirThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Boceprevir.Withdrawn
BosutinibThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Bosutinib.Approved
BromocriptineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Bromocriptine.Approved, Investigational
BuprenorphineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Buprenorphine.Approved, Illicit, Investigational, Vet Approved
BuspironeThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Buspirone.Approved, Investigational
CabazitaxelThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Cabazitaxel.Approved
CaffeineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Caffeine.Approved
CanagliflozinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Canagliflozin.Approved
CandesartanThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Candesartan.Approved
CaptoprilThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Captopril.Approved
CarbamazepineThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Carbamazepine.Approved, Investigational
CarvedilolThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Carvedilol.Approved, Investigational
CaspofunginThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Caspofungin.Approved
ChloroquineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Chloroquine.Approved, Vet Approved
ChlorpromazineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Chlorpromazine.Approved, Vet Approved
ChlorpropamideThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Chlorpropamide.Approved
ChlorprothixeneThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Chlorprothixene.Approved, Withdrawn
CholesterolThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Cholesterol.Experimental
Cholic AcidThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Cholic Acid.Approved
CilazaprilThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Cilazapril.Approved
CimetidineThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Cimetidine.Approved
CiprofloxacinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Ciprofloxacin.Approved, Investigational
CitalopramThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Citalopram.Approved
ClarithromycinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Clarithromycin.Approved
ClofazimineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Clofazimine.Approved, Investigational
ClomipramineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Clomipramine.Approved, Vet Approved
Clostridium tetani toxoid antigen (formaldehyde inactivated)The therapeutic efficacy of Clostridium tetani toxoid antigen (formaldehyde inactivated) can be decreased when used in combination with Inotuzumab ozogamicin.Approved
ClotrimazoleThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Clotrimazole.Approved, Vet Approved
CobicistatThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Cobicistat.Approved
ColchicineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Colchicine.Approved
ColforsinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Colforsin.Experimental
Corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated)The therapeutic efficacy of Corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) can be decreased when used in combination with Inotuzumab ozogamicin.Approved
CrizotinibThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Crizotinib.Approved
CyclophosphamideThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Cyclophosphamide.Approved, Investigational
CyclosporineThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Cyclosporine.Approved, Investigational, Vet Approved
DaclatasvirThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Daclatasvir.Approved
DactinomycinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Dactinomycin.Approved
DasatinibThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Dasatinib.Approved, Investigational
DaunorubicinThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Daunorubicin.Approved
DesipramineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Desipramine.Approved
DesloratadineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Desloratadine.Approved, Investigational
DexamethasoneThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Dexamethasone.Approved, Investigational, Vet Approved
DextromethorphanThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Dextromethorphan.Approved
DiclofenacThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Diclofenac.Approved, Vet Approved
DigoxinThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Digoxin.Approved
DihydroergotamineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Dihydroergotamine.Approved
DiltiazemThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Diltiazem.Approved
DipyridamoleThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Dipyridamole.Approved
DoxazosinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Doxazosin.Approved
DoxepinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Doxepin.Approved
DoxorubicinThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Doxorubicin.Approved, Investigational
DronabinolThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Dronabinol.Approved, Illicit
DronedaroneThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Dronedarone.Approved
ElbasvirThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Elbasvir.Approved
EnalaprilThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Enalapril.Approved, Vet Approved
EnasidenibThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Enasidenib.Approved
EnzalutamideThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Enzalutamide.Approved
ErgonovineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Ergonovine.Approved
ErgotamineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Ergotamine.Approved
ErythromycinThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Erythromycin.Approved, Vet Approved
EstramustineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Estramustine.Approved
EstriolThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Estriol.Approved, Vet Approved
EstroneThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Estrone.Approved
EtoposideThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Etoposide.Approved
EtravirineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Etravirine.Approved
FelodipineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Felodipine.Approved, Investigational
FentanylThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Fentanyl.Approved, Illicit, Investigational, Vet Approved
FexofenadineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Fexofenadine.Approved
FidaxomicinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Fidaxomicin.Approved
FluconazoleThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Fluconazole.Approved
FluoxetineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Fluoxetine.Approved, Vet Approved
FlupentixolThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Flupentixol.Approved, Withdrawn
FluphenazineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Fluphenazine.Approved
FlurazepamThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Flurazepam.Approved, Illicit
FluvoxamineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Fluvoxamine.Approved, Investigational
G17DTThe therapeutic efficacy of G17DT can be decreased when used in combination with Inotuzumab ozogamicin.Investigational
GefitinibThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Gefitinib.Approved, Investigational
GenisteinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Genistein.Investigational
GI-5005The therapeutic efficacy of GI-5005 can be decreased when used in combination with Inotuzumab ozogamicin.Investigational
GlecaprevirThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Glecaprevir.Approved
GlyburideThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Glyburide.Approved
GlycerinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Glycerin.Approved, Investigational
Gramicidin DThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Gramicidin D.Approved
GrepafloxacinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Grepafloxacin.Withdrawn
HaloperidolThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Haloperidol.Approved
HydrocortisoneThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Hydrocortisone.Approved, Vet Approved
IdelalisibThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Idelalisib.Approved
ImatinibThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Imatinib.Approved
ImipramineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Imipramine.Approved
IndinavirThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Indinavir.Approved
IndomethacinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Indomethacin.Approved, Investigational
INGN 201The therapeutic efficacy of INGN 201 can be decreased when used in combination with Inotuzumab ozogamicin.Investigational
INGN 225The therapeutic efficacy of INGN 225 can be decreased when used in combination with Inotuzumab ozogamicin.Investigational
IsavuconazoniumThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Isavuconazonium.Approved, Investigational
ItraconazoleThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Itraconazole.Approved, Investigational
IvacaftorThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Ivacaftor.Approved
IvermectinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Ivermectin.Approved, Vet Approved
KetamineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Ketamine.Approved, Vet Approved
KetoconazoleThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Ketoconazole.Approved, Investigational
LansoprazoleThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Lansoprazole.Approved, Investigational
LapatinibThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Lapatinib.Approved, Investigational
LevofloxacinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Levofloxacin.Approved, Investigational
LevothyroxineThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Levothyroxine.Approved
LidocaineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Lidocaine.Approved, Vet Approved
LiothyronineThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Liothyronine.Approved, Vet Approved
LiotrixThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Liotrix.Approved
LisinoprilThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Lisinopril.Approved, Investigational
LomitapideThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Lomitapide.Approved
LoperamideThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Loperamide.Approved
LopinavirThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Lopinavir.Approved
LoratadineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Loratadine.Approved
LosartanThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Losartan.Approved
LovastatinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Lovastatin.Approved, Investigational
MaprotilineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Maprotiline.Approved
MebendazoleThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Mebendazole.Approved, Vet Approved
MefloquineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Mefloquine.Approved
Megestrol acetateThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Megestrol acetate.Approved, Vet Approved
MeprobamateThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Meprobamate.Approved, Illicit
MethadoneThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Methadone.Approved
MetoprololThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Metoprolol.Approved, Investigational
MibefradilThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Mibefradil.Withdrawn
MiconazoleThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Miconazole.Approved, Investigational, Vet Approved
MidazolamThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Midazolam.Approved, Illicit
MifepristoneThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Mifepristone.Approved, Investigational
MitomycinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Mitomycin.Approved
MitoxantroneThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Mitoxantrone.Approved, Investigational
MorphineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Morphine.Approved, Investigational
NaltrexoneThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Naltrexone.Approved, Investigational, Vet Approved
NaringeninThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Naringenin.Experimental
NefazodoneThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Nefazodone.Approved, Withdrawn
NelfinavirThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Nelfinavir.Approved
NeostigmineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Neostigmine.Approved, Vet Approved
NicardipineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Nicardipine.Approved
NifedipineThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Nifedipine.Approved
NilotinibThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Nilotinib.Approved, Investigational
NisoldipineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Nisoldipine.Approved
NitrazepamThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Nitrazepam.Approved
NitrendipineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Nitrendipine.Approved
NorethisteroneThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Norethisterone.Approved
OmeprazoleThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Omeprazole.Approved, Investigational, Vet Approved
P-NitrophenolThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with P-Nitrophenol.Experimental
PaclitaxelThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Paclitaxel.Approved, Vet Approved
Palmitic AcidThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Palmitic Acid.Experimental
PantoprazoleThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Pantoprazole.Approved
ParoxetineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Paroxetine.Approved, Investigational
PerindoprilThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Perindopril.Approved
PhenobarbitalThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Phenobarbital.Approved
PibrentasvirThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Pibrentasvir.Approved
PimozideThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Pimozide.Approved
Platelet Activating FactorThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Platelet Activating Factor.Experimental
PonatinibThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Ponatinib.Approved
PosaconazoleThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Posaconazole.Approved, Investigational, Vet Approved
PravastatinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Pravastatin.Approved
PrazosinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Prazosin.Approved
PrednisoneThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Prednisone.Approved, Vet Approved
ProbenecidThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Probenecid.Approved
ProgesteroneThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Progesterone.Approved, Vet Approved
PromethazineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Promethazine.Approved
PropafenoneThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Propafenone.Approved
PropranololThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Propranolol.Approved, Investigational
ProtriptylineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Protriptyline.Approved
QuercetinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Quercetin.Experimental
QuinacrineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Quinacrine.Approved
QuinidineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Quinidine.Approved
QuinineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Quinine.Approved
Rabies virus inactivated antigen, AThe therapeutic efficacy of Rabies virus inactivated antigen, A can be decreased when used in combination with Inotuzumab ozogamicin.Approved
RanitidineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Ranitidine.Approved
RanolazineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Ranolazine.Approved, Investigational
ReboxetineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Reboxetine.Approved, Investigational
RegorafenibThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Regorafenib.Approved
ReserpineThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Reserpine.Approved
RifampicinThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Rifampicin.Approved
RilpivirineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Rilpivirine.Approved
RindopepimutThe therapeutic efficacy of Rindopepimut can be decreased when used in combination with Inotuzumab ozogamicin.Investigational
RitonavirThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Ritonavir.Approved, Investigational
RolapitantThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Rolapitant.Approved
Rotavirus VaccineThe therapeutic efficacy of Rotavirus Vaccine can be decreased when used in combination with Inotuzumab ozogamicin.Approved
Rubella virus vaccineThe therapeutic efficacy of Rubella virus vaccine can be decreased when used in combination with Inotuzumab ozogamicin.Approved
SaquinavirThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Saquinavir.Approved, Investigational
ScopolamineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Scopolamine.Approved
SelegilineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Selegiline.Approved, Investigational, Vet Approved
SertralineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Sertraline.Approved
SimeprevirThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Simeprevir.Approved
SimvastatinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Simvastatin.Approved
SirolimusThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Sirolimus.Approved, Investigational
SorafenibThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Sorafenib.Approved, Investigational
SpironolactoneThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Spironolactone.Approved
SRP 299The therapeutic efficacy of SRP 299 can be decreased when used in combination with Inotuzumab ozogamicin.Investigational
St. John's WortThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with St. John's Wort.Nutraceutical
StaurosporineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Staurosporine.Experimental
StreptozocinThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Streptozocin.Approved
SulfinpyrazoneThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Sulfinpyrazone.Approved
SumatriptanThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Sumatriptan.Approved, Investigational
SunitinibThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Sunitinib.Approved, Investigational
TacrineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Tacrine.Withdrawn
TacrolimusThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Tacrolimus.Approved, Investigational
TamoxifenThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Tamoxifen.Approved
Taurocholic AcidThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Taurocholic Acid.Experimental
TecemotideThe therapeutic efficacy of Tecemotide can be decreased when used in combination with Inotuzumab ozogamicin.Investigational
TelaprevirThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Telaprevir.Withdrawn
TelmisartanThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Telmisartan.Approved, Investigational
TemsirolimusThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Temsirolimus.Approved
TerazosinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Terazosin.Approved
TerfenadineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Terfenadine.Withdrawn
TesmilifeneThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Tesmilifene.Investigational
TestosteroneThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Testosterone.Approved, Investigational
TG4010The therapeutic efficacy of TG4010 can be decreased when used in combination with Inotuzumab ozogamicin.Investigational
TicagrelorThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Ticagrelor.Approved
TolvaptanThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Tolvaptan.Approved
TrazodoneThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Trazodone.Approved, Investigational
TrifluoperazineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Trifluoperazine.Approved
TriflupromazineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Triflupromazine.Approved, Vet Approved
TrimethoprimThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Trimethoprim.Approved, Vet Approved
TrimipramineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Trimipramine.Approved
TroleandomycinThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Troleandomycin.Approved
VelpatasvirThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Velpatasvir.Approved
VenlafaxineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Venlafaxine.Approved
VerapamilThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Verapamil.Approved
VinblastineThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Vinblastine.Approved
VincristineThe serum concentration of Inotuzumab ozogamicin can be decreased when it is combined with Vincristine.Approved, Investigational
VinorelbineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Vinorelbine.Approved, Investigational
VoxilaprevirThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Voxilaprevir.Approved
Yellow fever vaccineThe therapeutic efficacy of Yellow fever vaccine can be decreased when used in combination with Inotuzumab ozogamicin.Approved
ZimelidineThe serum concentration of Inotuzumab ozogamicin can be increased when it is combined with Zimelidine.Withdrawn
Zoster vaccineThe therapeutic efficacy of Zoster vaccine can be decreased when used in combination with Inotuzumab ozogamicin.Approved
Food Interactions
Not Available

References

Synthesis Reference
Not Available
General References
  1. DiJoseph JF, Goad ME, Dougher MM, Boghaert ER, Kunz A, Hamann PR, Damle NK: Potent and specific antitumor efficacy of CMC-544, a CD22-targeted immunoconjugate of calicheamicin, against systemically disseminated B-cell lymphoma. Clin Cancer Res. 2004 Dec 15;10(24):8620-9. [PubMed:15623646]
  2. Dijoseph JF, Dougher MM, Armellino DC, Evans DY, Damle NK: Therapeutic potential of CD22-specific antibody-targeted chemotherapy using inotuzumab ozogamicin (CMC-544) for the treatment of acute lymphoblastic leukemia. Leukemia. 2007 Nov;21(11):2240-5. Epub 2007 Jul 26. [PubMed:17657218]
  3. Han TH, Zhao B: Absorption, distribution, metabolism, and excretion considerations for the development of antibody-drug conjugates. Drug Metab Dispos. 2014 Nov;42(11):1914-20. doi: 10.1124/dmd.114.058586. Epub 2014 Jul 21. [PubMed:25048520]
  4. Yilmaz M, Richard S, Jabbour E: The clinical potential of inotuzumab ozogamicin in relapsed and refractory acute lymphocytic leukemia. Ther Adv Hematol. 2015 Oct;6(5):253-61. doi: 10.1177/2040620715596715. [PubMed:26425338]
  5. Kantarjian HM, DeAngelo DJ, Stelljes M, Martinelli G, Liedtke M, Stock W, Gokbuget N, O'Brien S, Wang K, Wang T, Paccagnella ML, Sleight B, Vandendries E, Advani AS: Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia. N Engl J Med. 2016 Aug 25;375(8):740-53. doi: 10.1056/NEJMoa1509277. Epub 2016 Jun 12. [PubMed:27292104]
  6. European Medicines Agency (EMA): BESPONSA Summary of Product Characteristics [Link]
External Links
Wikipedia
Inotuzumab_ozogamicin
ATC Codes
Not Available
AHFS Codes
Not Available
PDB Entries
Not Available
FDA label
Not Available
MSDS
Not Available

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1Active Not RecruitingTreatmentAcute Lymphoblastic Leukaemias (ALL)1
1CompletedTreatmentLymphoma, B-Cell4
1CompletedTreatmentRefractory Follicular Lymphoma1
1RecruitingTreatmentAcute Leukemias of Ambiguous Lineage / B-cell Adult Acute Lymphoblastic Leukemia / Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia / Recurrent Adult Acute Lymphoblastic Leukemia / Recurrent Adult Burkitt Lymphoma1
1, 2Active Not RecruitingTreatmentAcute Lymphocytic Leukemia (ALL)1
1, 2CompletedTreatmentLymphoma, B-Cell1
1, 2RecruitingTreatmentAcute Lymphoblastic Leukaemias (ALL) / Leukemias1
1, 2RecruitingTreatmentCD22-positive Acute Lymphoblastic Leukemia / Cluster of Differentiation Antigen (CD22)-Positive Acute Lymphoblastic Leukemia1
1, 2RecruitingTreatmentLeukemias1
1, 2RecruitingTreatmentLeukemias / Malignant Lymphomas1
2CompletedTreatmentLymphoma, B-Cell1
2CompletedTreatmentMalignant Lymphomas1
2Not Yet RecruitingTreatmentAcute Lymphocytic Leukemia (ALL)1
2RecruitingTreatmentChildhood B Acute Lymphoblastic Leukemia / Recurrent Childhood Acute Lymphoblastic Leukemia / Refractory Childhood Acute Lymphoblastic Leukemia1
2RecruitingTreatmentLymphoma, Large B-Cell, Diffuse (DLBCL)1
3Active Not RecruitingTreatmentAcute Lymphoblastic Leukaemias (ALL)1
3RecruitingTreatmentB Acute Lymphoblastic Leukemia1
3TerminatedHealth Services ResearchFollicular Lymphoma (FL)1
3TerminatedTreatmentNon-Hodgkin's Lymphoma (NHL)1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
Injection, powder, lyophilized, for solutionIntravenous.25 mg/mL
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Taxonomy

Description
Not Available
Kingdom
Organic Compounds
Super Class
Organic Acids
Class
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Peptides
Alternative Parents
Not Available
Substituents
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available

Targets

Kind
Protein
Organism
Human
Pharmacological action
Yes
Actions
Antibody
General Function
Carbohydrate binding
Specific Function
Mediates B-cell B-cell interactions. May be involved in the localization of B-cells in lymphoid tissues. Binds sialylated glycoproteins; one of which is CD45. Preferentially binds to alpha-2,6-link...
Gene Name
CD22
Uniprot ID
P20273
Uniprot Name
B-cell receptor CD22
Molecular Weight
95347.07 Da
References
  1. Thota S, Advani A: Inotuzumab ozogamicin in relapsed B-cell acute lymphoblastic leukemia. Eur J Haematol. 2017 May;98(5):425-434. doi: 10.1111/ejh.12862. Epub 2017 Mar 9. [PubMed:28152223]

Transporters

Kind
Protein
Organism
Human
Pharmacological action
Unknown
Actions
Substrate
General Function
Xenobiotic-transporting atpase activity
Specific Function
Energy-dependent efflux pump responsible for decreased drug accumulation in multidrug-resistant cells.
Gene Name
ABCB1
Uniprot ID
P08183
Uniprot Name
Multidrug resistance protein 1
Molecular Weight
141477.255 Da
References
  1. European Medicines Agency (EMA): BESPONSA Summary of Product Characteristics [Link]

Drug created on November 18, 2007 11:28 / Updated on August 18, 2017 11:46