Gemtuzumab ozogamicin 5mg powder for solution for infusion vials
Requires a prescription from a doctor or prescriber
Gemtuzumab ozogamicin is a recombinant humanized IgG4 kappa antibody which is conjugated with calicheamicin derivative, a cytotoxic antitumor antibiotic isolated from fermentation of Micromonospora echinospora ssp.
Official documents, adverse reaction reporting, and safety monitoring
Report a side effect
Submit a Yellow Card report to the MHRA
Official medicine documents
Yellow Card
Report side effects (MHRA)
Drug safety updates
MHRA alerts for Gemtuzumab ozogamicin
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
View Drug Analysis Profile
Browse all Drug Analysis Profiles A–Z
Browse all iDAP reports
Interactive Drug Analysis Profiles for all medicines
Report a side effect
Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
View EudraVigilance report
Suspected adverse reactions reported for Gemtuzumab ozogamicin
About EudraVigilance
Learn about EU pharmacovigilance and safety monitoring
EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
1 branded products available
MHRA licensed products
View all licensed products for Gemtuzumab ozogamicin on the MHRA register
Mylotarg 5mg powder for concentrate for solution for infusion vials
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(2)
Gemtuzumab ozogamicin for untreated acute myeloid leukaemia (TA545)
Ivosidenib with azacitidine for untreated acute myeloid leukaemia with an IDH1 R132 mutation (TA979)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
Pharmacy stock checkers
Search for this medicine at major UK pharmacy chains. These links open the retailer's own website — results depend on their current online catalogue.
Supply & safety information
Official UK regulator monitoring and safety alerts
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 26 · Randomised trials: 5 · 2004–2025
Showing the 50 most relevant studies, sorted by most relevant.
C. Godwin, R. Gale, Roland B. Walter
Leukemia, 2017
- Aminoglycosides
- Prognosis
- Genotype
J. Lamba, Lata Chauhan, Miyoung Shin, et al.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2017
Adkins BD, Noland DK, Slone T, et al.
2024
- Hemoglobins
- Plasma Exchange
- Gemtuzumab
Gemtuzumab ozogamicin (GO) is a CD33 monoclonal antibody-drug conjugate currently in use to treat myeloid malignancies. A unique adverse effect of this medication is destruction of CD33 positive macrophages resulting in reduced clearance of free hemoglobin leading to grossly red plasma. This build-up of free hemoglobin can potentially lead to end organ damage and prevent performance of clinically necessary laboratory evaluation. We present a case of a pediatric patient who developed this adverse effect and was successfully treated with therapeutic plasma exchange (TPE). We also present results from a systematic review of the medical literature and share data from a query of the United States Food and Drug Administration (FDA) Adverse Event Reporting system for GO-related hemoglobin scavenging impairment. Among reported cases, patients undergoing TPE and those receiving steroids had improved outcomes. Practitioners should be aware of this rare drug side-effect and the potential utility of TPE for these patients.
Abstract licence: CC BY-NC-ND
Awada H, Abdelmalek M, Cronin T, et al.
2023
- Leukemia, Myeloid, Acute
- Cytogenetic Analysis
- Gemtuzumab
Döhner H, Weber D, Krzykalla J, et al.
2023
- Neoplasm Recurrence, Local
- Leukemia, Myeloid, Acute
- Tretinoin
Garrett Bourne, Kendall Diebold, Manuel Espinoza-Gutarra, et al.
Leukemia research, 2024
- Leukemia, Myeloid, Acute
- Antibodies, Monoclonal, Humanized
- Aminoglycosides
Sahra Ali, Helen Dunmore, Dominik Karres, et al.
The oncologist, 2019
- Drug Approval
- Daunorubicin
- Cytarabine
Li J, Yin X
2022
- Leukemia, Myeloid, Acute
- Gemtuzumab
Guo Y, Deng L, Qiao Y, et al.
2022
- Recurrence
- Antineoplastic Combined Chemotherapy Protocols
- Prognosis
Nor Asiah Muhamad, N. S. Mohd Dali, Aliza Mohd Yacob, et al.
BMJ Open, 2020
- Research Design
- Leukemia, Myeloid, Acute
- Antineoplastic Agents, Immunological
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
44 h
Mechanism
Mylotarg is directed against the CD33 antigen expressed by hematopoietic cells.
Food interactions
None known
Human targets
4 targets
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
9mg/m
Half-life
9mg/m
[A20377]
Volume of distribution
5.5 L
[A20377]
Metabolism
Clearance
0.15 L/h
[A20377]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Marketing approval of gemtuzumab ozogamicin was granted on May 17, 2000 by FDA as a treatment for patients with CD33-positive AML in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy [A98]. However, it was voluntarily withdrawn from the market in 2010 due to safety concerns, increased patient deaths and insufficient evidence of clinical benefit during confirmatory trials [L941]. On September 1 2017, gemtuzumab ozogamicin was again approved for the treatment of adults with newly diagnosed CD33-positive acute myeloid leukemia but with a lower dosing regimen and a different schedule in combination with chemotherapy or on its own [L941]. It is also indicated for the treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial treatment (refractory) [L941].
Known interactions with other medicines. Always consult a healthcare professional.
Showing 50 of 853 interactions
How the body processes this drug — absorption, distribution, metabolism, and elimination
[A20377]
[A20377]
[A20377]
[A20377]
Proteins and enzymes this drug interacts with in the body
PMID:10611343 PMID:11320212 PMID:15597323
Preferentially recognizes and binds alpha-2,3- and more avidly alpha-2,6-linked sialic acid-bearing glycans .
PMID:7718872
Upon engagement of ligands such as C1q or syalylated glycoproteins, two immunoreceptor tyrosine-based inhibitory motifs (ITIMs) located in CD33 cytoplasmic tail are phosphorylated by Src-like kinases such as LCK .
PMID:10887109 PMID:28325905
These phosphorylations provide docking sites for the recruitment and activation of protein-tyrosine phosphatases PTPN6/SHP-1 and PTPN11/SHP-2 .
PMID:10206955 PMID:10556798 PMID:10887109
In turn, these phosphatases regulate downstream pathways through dephosphorylation of signaling molecules .
PMID:10206955 PMID:10887109
One of the repressive effect of CD33 on monocyte activation requires phosphoinositide 3-kinase/PI3K PMID:15597323
Contrary to III-A, is not capable to mediate antibody-dependent cytotoxicity and phagocytosis. May serve as a trap for immune complexes in the peripheral circulation which does not activate neutrophils
PMID:11711607 PMID:21768335 PMID:22023369 PMID:24412922 PMID:25786175 PMID:25816339 PMID:28652325 PMID:8609432 PMID:9242542
Mediates IgG effector functions on natural killer (NK) cells.
Binds antigen-IgG complexes generated upon infection and triggers NK cell-dependent cytokine production and degranulation to limit viral load and propagation. Involved in the generation of memory-like adaptive NK cells capable to produce high amounts of IFNG and to efficiently eliminate virus-infected cells via ADCC .
PMID:24412922 PMID:25786175
Regulates NK cell survival and proliferation, in particular by preventing NK cell progenitor apoptosis .
PMID:29967280 PMID:9916693
Fc-binding subunit that associates with CD247 and/or FCER1G adapters to form functional signaling complexes. Following the engagement of antigen-IgG complexes, triggers phosphorylation of immunoreceptor tyrosine-based activation motif (ITAM)-containing adapters with subsequent activation of phosphatidylinositol 3-kinase signaling and sustained elevation of intracellular calcium that ultimately drive NK cell activation.
The ITAM-dependent signaling coupled to receptor phosphorylation by PKC mediates robust intracellular calcium flux that leads to production of pro-inflammatory cytokines, whereas in the absence of receptor phosphorylation it mainly activates phosphatidylinositol 3-kinase signaling leading to cell degranulation .
PMID:1825220 PMID:23024279 PMID:2532305
Costimulates NK cells and trigger lysis of target cells independently of IgG binding .
PMID:10318937 PMID:23006327
Mediates the antitumor activities of therapeutic antibodies. Upon ligation on monocytes triggers TNFA-dependent ADCC of IgG-coated tumor cells .
PMID:27670158
Mediates enhanced ADCC in response to afucosylated IgGs PMID:34485821
ATC L01FX02
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Show
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Gemtuzumab ozogamicin
Additional database identifiers
Drugs Product Database (DPD)
23390
HUGO Gene Nomenclature Committee (HGNC)
HGNC:1659
GenAtlas
CD33
GeneCards
CD33
GenBank Gene Database
M23197
GenBank Protein Database
180098
Guide to Pharmacology
2601
UniProt Accession
CD33_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:3620
GenAtlas
FCGR3B
GeneCards
FCGR3B
GenBank Gene Database
X16863
GenBank Protein Database
31322
UniProt Accession
FCG3B_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:3619
GenAtlas
FCGR3A
GeneCards
FCGR3A
GenBank Gene Database
X52645
GenBank Protein Database
31324
Guide to Pharmacology
3017
UniProt Accession
FCG3A_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:3613
GenAtlas
FCGR1A
GeneCards
FCGR1A
GenBank Gene Database
X14356
GenBank Protein Database
31332
UniProt Accession
FCGR1_HUMAN
DrugBank citations
If you use DrugBank data in your research, please cite:
- DrugBank 6.02024Recommended citationKnox C., Wilson M., Klinger C.M., et alDrugBank 6.0: the DrugBank Knowledgebase for 2024Nucleic Acids Res. 2024 Jan 552(D1):D1265-D1275
- DrugBank 5.02018Wishart D.S., Feunang Y.D., Guo A.C., et alDrugBank 5.0: a major update to the DrugBank database for 2018Nucleic Acids Res. 2017 Nov 846(D1):D1074-D1082
- DrugBank 4.02014Law V., Knox C., Djoumbou Y., et alDrugBank 4.0: shedding new light on drug metabolismNucleic Acids Res. 2014 Jan 142(1):D1091-7
- DrugBank 3.02011Knox C., Law V., Jewison T., et alDrugBank 3.0: a comprehensive resource for 'omics' research on drugsNucleic Acids Res. 2011 Jan39(Database issue):D1035-41
- DrugBank 2.02008Wishart D.S., Knox C., Guo A.C., et alDrugBank: a knowledgebase for drugs, drug actions and drug targets.Nucleic Acids Research2008 Jan36(Database issue):D901-6
- DrugBank 1.02006Wishart D.S., Knox C., Guo A.C., et alDrugBank: a comprehensive resource for in silico drug discovery and exploration.Nucleic Acids Research2006 Jan 134(Database issue):D668-72