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FDA Files Application To Convert ONTAK(R) (Denileukin Diftitox) to Full Approval for Use in Cutaneous T-Cell Lymphoma (CTCL)
Date:6/26/2008

patients were hospitalized for the management of these symptoms.

-- The onset of symptoms in patients with vascular leak syndrome was delayed, usually occurring within the first two weeks of infusion; symptoms may persist or worsen after the cessation of denileukin diftitox.

-- Cases of vascular (capillary) leak with a fatal outcome have been reported.

-- Special caution should be taken in patients with preexisting cardiovascular disease (See ADVERSE REACTIONS, Cardiovascular System).

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. Pre-existing 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.

PRECAUTIONS:

General

Patients should be monitored carefully for infection since patients with CTCL have a predisposition to cutaneous infection.

Pregnancy Category C

Animal reproduction studies have not been conducted with ONTAK. It is also not known whether ONTAK can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. ONTAK should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, patients receiving ONTAK should discontinue nursing.

ADVERSE
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SOURCE Eisai Corporation of North America
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