( r. The safety andefficacy of denileuki...)Ontak (denileukin diftitox) Achieves 49.1% Overall Response Rate in,Phase III Trial of Cutaneous T-Cell Lymphoma (CTCL),Health

Important Safety Information

WARNING: Only physicians experienced in the use of antineoplastic therapy and management of patients with cancer should use ONTAK (denileukin diftitox). Patients treated with denileukin diftitox must be managed in a facility equipped and staffed for cardiopulmonary resuscitation and where the patient can be closely monitored for an appropriate period based on his or her health status.

    WARNINGS

    Acute Hypersensitivity-type Reactions:


    -- Acute hypersensitivity reactions were reported in 98 of 143 patients

       (69%) during or within 24 hours of ONTAK infusion; approximately half

       of the events occurred on the first day of dosing regardless of the

       treatment cycle.

    -- The constellation of symptoms included one or more of the following,

       defined as the incidence (%) in these 98 patients: hypotension (50%),

       back pain (30%), dyspnea (28%), vasodilation (28%), rash (25%), chest

       pain or tightness (24%), tachycardia (12%), dysphagia or laryngismus

       (5%), syncope (3%), allergic reaction (1%) or anaphylaxis (1%).

    -- These events were severe in 2% of patients. Death during infusion has

       been reported.


    Vascular Leak Syndrome:


    -- This syndrome, characterized by 2 or more of the following 3 symptoms

       (hypotension, edema, hypoalbuminemia) was reported in 27% (38/143) of

       patients in the clinical studies.

    -- Six percent (8/143) of 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
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