Substance / Medication

Gemtuzumab ozogamicin

Overview

Active Ingredient
gemtuzumab ozogamicin
RxNorm CUI
1294580
Labeler: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.Updated: 2025-12-19T00:00:00.000ZFull label on DailyMed

Boxed Warning

FDA Black Box Warning

5.1 6.1 Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG as a single agent, and as part of a combination chemotherapy regimen. Monitor frequently for signs an

Contraindications

When this intervention should not be used

Warnings and Precautions (5.2) Adverse Reactions (6) [see,] MYLOTARG is contraindicated in patients with a history of hypersensitivity to the active substance in MYLOTARG or any of its components or to any of the excipients. Reactions have included anaphylaxis.

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Research Evidence

Published studies and systematic reviews

Sort:
Therapeutic plasma exchange as an intervention for gemtuzumab ozogamicin impaired hemoglobin scavenging: A case and systematic review.
Adkins Brian D, Noland Daniel K, Slone Tamra et al. · J Clin Apher · 2024
PMID: 38647036Meta-Analysis
Addition of single dose gemtuzumab ozogamicin to intensive induction chemotherapy in core-binding factor acute myeloid leukemia.
Bourne Garrett, Diebold Kendall, Espinoza-Gutarra Manuel et al. · Leuk Res · 2024
PMID: 38460432Meta-Analysis
Gemtuzumab ozogamicin for treatment of newly diagnosed CD33-positive acute myeloid leukemia.
Gbadamosi Mohammed, Meshinchi Soheil, Lamba Jatinder K · Future Oncol · 2018
PMID: 30039981Meta-AnalysisFull text (PMC)
Gemtuzumab ozogamicin in infants with AML: results from the Children's Oncology Group trials AAML03P1 and AAML0531.
Guest Erin M, Aplenc Richard, Sung Lillian et al. · Blood · 2017
PMID: 28674028Meta-AnalysisFull text (PMC)
Gemtuzumab ozogamicin for treatment of newly diagnosed acute myeloid leukaemia: a systematic review and meta-analysis.
Kharfan-Dabaja Mohamed A, Hamadani Mehdi, Reljic Tea et al. · Br J Haematol · 2013
PMID: 24033280Meta-Analysis

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type
Substance / Medication
Fully Specified Name
Gemtuzumab ozogamicin (substance)
SNOMED CT
127964000
UMLS CUI
C1533699
RxNorm CUI
1294580
Labeler
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

Clinical Data

This intervention maps to 2 entities in the Healos knowledge graph.

2
Conditions
0
Biomarkers
0
Specialists
0
Symptoms

Data is sourced from SNOMED CT, UMLS, and the Healos clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.