Chemical: Drug
denileukin diftitox
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1. Annotation of FDA Label for denileukin diftitox and IL2RA
Summary
The FDA-approved drug label for denileukin diftitox (Ontak) notes that it is indicated for patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor. Confirmation of malignant cells expressing CD25 is necessary prior to administration of the drug.
Annotation
Denileukin diftitox (Ontak) is indicated for patients with persistent or recurrent cutaneous T-cell lymphoma. The FDA-approved drug label for denileukin diftitox states that confirmation that a patient's malignant cells express CD25 is necessary prior to beginning treatment with the drug.
Excerpts from the denileukin diftitox (Ontak) label:
Ontak is a CD25-directed cytotoxin indicated for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor.
CD25 Tumor Expression and Evaluation...Confirm that the patient's malignant cells express CD25 prior to administration of Ontak. A testing service for the assay of CD25 expression in tumor biopsy samples is available.
For the complete drug label text with sections containing pharmacogenetic information highlighted, see the denileukin diftitox drug label.
*Disclaimer: The contents of this page have not been endorsed by the FDA and are the sole responsibility of PharmGKB.
Genes and/or phenotypes found in this label
-
IL2RA
- efficacy, Indications & usage section, Description section, Clinical pharmacology section, Warnings and precautions section
- source: U.S. Food and Drug Administration
PharmGKB contains no Clinical Variants that meet the highest level of criteria.
Disclaimer: The PharmGKB's clinical annotations reflect expert consensus based on clinical evidence and peer-reviewed literature available at the time they are written and are intended only to assist clinicians in decision-making and to identify questions for further research. New evidence may have emerged since the time an annotation was submitted to the PharmGKB. The annotations are limited in scope and are not applicable to interventions or diseases that are not specifically identified.
The annotations do not account for individual variations among patients, and cannot be considered inclusive of all proper methods of care or exclusive of other treatments. It remains the responsibility of the health-care provider to determine the best course of treatment for a patient. Adherence to any guideline is voluntary, with the ultimate determination regarding its application to be made solely by the clinician and the patient. PharmGKB assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of the PharmGKB clinical annotations, or for any errors or omissions.
Overview
- DT
- Diphtheria toxin precursor
- NAD(+--diphthamide ADP- ribosyltransferase)
- denileukin diftitox
- Ontak
- Ontak (Seragen Inc)
PharmGKB Accession Id
PA164750594
Type(s):
Drug
Description
Source: Drug Bank
Other Vocabularies
- ATC: Other antineoplastic agents (L01XX)
- UMLS: denileukin diftitox (C0717670)
- RxNorm: denileukin diftitox (214470)
Information pulled from DrugBank has not been reviewed by PharmGKB.
Pharmacology, Interactions, and Contraindications
Mechanism of Action
Source: Drug Bank
Pharmacology
Source: Drug Bank
Absorption, Distribution, Metabolism, Elimination & Toxicity
Chemical Properties
Genes that are associated with this drug in PharmGKB's database based on (1) variant annotations, (2) literature review, (3) pathways or (4) information automatically retrieved from DrugBank, depending on the "evidence" and "source" listed below.
Curated Information ?
Drug Targets
| Gene | Description |
|---|---|
| IL2RA | (source: Drug Bank ) |
| IL2RB | (source: Drug Bank ) |
| IL2RG | (source: Drug Bank ) |
Publications related to denileukin diftitox: 2
|
Denileukin Diftitox (Ontak) as Maintenance Therapy for Peripheral T-Cell Lymphomas: Three Cases with Sustained Remission. Case reports in oncological medicine. 2015. Fuentes Alejandra C, et al.
|
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|
Interleukin 2 (IL-2) receptor expression and sensitivity to diphteria fusion toxin DAB389IL-2 in cultured hematopoietic cells. Cancer research. 1996. Re G G, et al.
|
LinkOuts
- UniProtKB:
- P00587
- National Drug Code Directory:
- 62856-603-01
- DrugBank:
- DB00004
- Therapeutic Targets Database:
- DAP001098
- FDA Drug Label at DailyMed:
- 42dfffb1-d0f3-42d5-944c-64f092fc436e
Clinical Trials
These are trials that mention denileukin diftitox and are related to either pharmacogenetics or pharmacogenomics.
NURSA Datasets
No NURSA datasets available.