( vascular (capillary) leak with a fatal...)Ontak (denileukin diftitox) Achieves 49.1% Overall Response Rate in,Phase III Trial of Cutaneous T-Cell Lymphoma (CTCL),Health

Weight, edema, blood pressure and serum albumin levels should be carefully monitored on an outpatient basis. This syndrome is usually self-limited and treatment should be used only if clinically indicated. The type of treatment will depend on whether edema or hypotension is the primary clinical problem. Preexisting low serum albumin levels appear to predict and may predispose patients to the syndrome (see PRECAUTIONS, Laboratory Tests).

    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.

ADVERSE REACTIONS

The most commonly reported adverse events associated with the use of ONTAK therapy (n=143 patients) include hypoalbuminemia (83%), chills/fever (81%), asthenia (66%), nausea/vomiting (64%), transaminase increase (61%), infection (48%), pain (48%), edema (47%), hypotension (36%), anorexia (36%), and rash (34%).

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 relation to drug exposure.

Special Senses: See WARNINGS: Visual Loss

For detailed safety information and full prescribing information about ONTAK(R) (denileukin diftitox), please see attached prescribing information or visit www.eisai.com.

About Eisai Inc.

Eisai Inc. is a U.S.
'"/>