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U.S. Department of Health and Human Services

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Changes in the Ontak (denileukin diftitiox) Package Insert to Include a Description of Ophthalmologic Adverse Events

On March 3, 2006, the Division of Biologic Oncology Products in FDA's Office of Oncology Drug Products (OODP) approved changes to the product labeling for denileukin diftitox (Ontak) to include a new warning on ophthalmologic adverse events. This information is based on post-marketing studies and spontaneous reports.

Ontak (denileukin diftitox) was approved in February 1999 to be used for the treatment of persistent or recurrent cutaneous T-cell lymphoma (orphan indication).

The following statement has been added to the WARNINGS section of the Ontak label:

“Visual Loss: Loss of visual acuity usually with loss of color vision with or without retinal pigment mottling has been reported following administration of Ontak. Recovery was reported in some of the affected patients; however, most patients reported persistent visual impairment.”

The following statement has been added to the ADVERSE REACTIONS section of the Ontak label as follows:

Post-Marketing"

The following adverse reactions have been identified during post approval use of ONTAK. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.”

“Special Senses: See WARNINGS: Visual Loss

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interaction, contraindications is available at: Drugs@FDA.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by phone at 1-800-FDA-1088; by facsimile 1-800-FDA-0178 by mail using the Form 3500