Denileukin diftitox: Difference between revisions

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| IUPAC_name = Diphtheria toxin-Interleukin-2 fusion protein
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==Overview==
<!--Drug Shortage Status-->
'''Denileukin diftitox''', otherwise known as '''Ontak''' is an antineoplastic agent, an engineered protein combining [[Interleukin-2]] and [[Diphtheria toxin]].  This can bind to [[IL2 receptor|Interleukin-2 receptors]]<ref name="pmid17187516">{{cite journal |author=Turturro F |title=Denileukin diftitox: a biotherapeutic paradigm shift in the treatment of lymphoid-derived disorders |journal=Expert Rev Anticancer Ther |volume=7 |issue=1 |pages=11-7 |year=2007 |pmid=17187516 |doi=10.1586/14737140.7.1.11}}</ref> and introduce the diphtheria toxin into cells that express those receptors, killing the cells.  In some [[Leukemia]]s and [[Lymphoma]]s malignant cells express these receptors, so denileukin diftitox can target these.


A recent study at the [[University of Louisville]] found the drug caused many stage IV [[malignant melanoma]] tumors to regress and even stabilize, extending patient life expectancy from about eight months to, as of now, more than a year- which is significant given metastatic malignant melanoma's grave prognosis and poor treatment response.   
|drugShortage=
}}


There is some evidence tying it to vision loss.<ref name="pmid17454642">{{cite journal |author=Park M, Liu GT, Piltz-Seymour J, ''et al'' |title=Vision loss following denileukin diftitox treatment: a case report of possible posterior ischemic optic neuropathy |journal=Leuk. Lymphoma |volume=48 |issue=4 |pages=808-11 |year=2007 |pmid=17454642 |doi=10.1080/10428190701268783}}</ref>
<!--Pill Image-->


==References==
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==External links==
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[http://www.fda.gov/medwatch/safety/2006/ONTAK_PI_3-1-06.pdf FDA Safety Alert]


{{Chemotherapeutic agents}}
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{{WikiDoc Sources}}

Revision as of 13:52, 4 February 2015

Denileukin diftitox
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Black Box Warning

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Denileukin diftitox is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Denileukin diftitox in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Denileukin diftitox in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Denileukin diftitox in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Denileukin diftitox in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Denileukin diftitox in pediatric patients.

Contraindications

  • Condition1

Warnings

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Denileukin diftitox in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Denileukin diftitox in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Denileukin diftitox in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Denileukin diftitox during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Denileukin diftitox with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Denileukin diftitox with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Denileukin diftitox with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Denileukin diftitox with respect to specific gender populations.

Race

There is no FDA guidance on the use of Denileukin diftitox with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Denileukin diftitox in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Denileukin diftitox in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Denileukin diftitox in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Denileukin diftitox in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Denileukin diftitox in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Denileukin diftitox in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Denileukin diftitox in the drug label.

Pharmacology

There is limited information regarding Denileukin diftitox Pharmacology in the drug label.

Mechanism of Action

Structure

File:Denileukin diftitox01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Denileukin diftitox in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Denileukin diftitox in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Denileukin diftitox in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Denileukin diftitox in the drug label.

How Supplied

Storage

There is limited information regarding Denileukin diftitox Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

{{#ask: Label Page::Denileukin diftitox |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Denileukin diftitox in the drug label.

Precautions with Alcohol

  • Alcohol-Denileukin diftitox interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)


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