These highlights do not include all the information needed to use Ontak safely and effectively. See full prescribing information for Ontak. ONTAK (denileukin diftitox) Solution for Intravenous use Initial U.S.
WARNING: SERIOUS INFUSION REACTIONS, CAPILLARY LEAK SYNDROME AND LOSS OF VISUAL ACUITY.
The following adverse reactions have been reported:

1  INDICATIONS AND USAGE
Ontak is indicated for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor [see Warnings and Precautions ( 5.4 )].

2  DOSAGE AND ADMINISTRATION
2.1  Dosing Schedule and Administration
2.2  Preparation and Administration
3  DOSAGE FORMS AND STRENGTHS
Single-use vial containing 150 mcg/mL (300 mcg in 2 mL).

4  CONTRAINDICATIONS
None.

5  WARNINGS AND PRECAUTIONS
5.1  Infusion Reactions
Infusion reactions, defined as symptoms occurring within 24 hours of infusion and resolving within 48 hours of the last infusion in that course, were reported in 70.5% (165/234) of Ontak-treated patients across 3 clinical studies utilizing the approved doses and schedule. Serious infusion reactions were reported in 8.1% (19/234) of Ontak-treated patients. There have been post-marketing reports of infusion reactions resulting in death.

For patients completing at least 4 courses of Ontak treatment in Study 1 [see Clinical Studies ( 14.1 )], the incidence of infusion reactions was lower in the 3 and 4 cycles as compared to the 1 and 2 cycles of Ontak.

Resuscitative equipment should be available during Ontak administration. Immediately stop and permanently discontinue Ontak for serious infusion reactions.

5.2  Capillary Leak Syndrome
Capillary leak syndrome was defined as the occurrence of at least 2 of the following 3 symptoms (hypotension, edema, serum albumin <3.0 g/dL) at any time during Ontak therapy. These symptoms were not required to occur simultaneously to be characterized as capillary leak syndrome. As defined, capillary leak syndrome was reported in 32.5% (76/234) of Ontak-treated patients. Among these 76 patients with capillary leak syndrome, one-third required hospitalization or medical intervention to prevent hospitalization. There have been post-marketing reports of capillary leak syndrome resulting in death.

The onset of symptoms in patients with capillary leak syndrome may be delayed, occurring up to 2 weeks following infusion. Symptoms may persist or worsen after the cessation of Ontak.

Regularly assess patients for weight gain, new onset or worsening edema, hypotension (including orthostatic changes) and monitor serum albumin levels prior to the initiation of each course of therapy and more often as clinically indicated. Withhold Ontak for serum albumin levels of less than 3.0 g/dL [see Warnings and Precautions ( 5.5 )].

5.3  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.

5.4  CD25 Tumor Expression and eva luation
Confirm that the patient's malignant cells express CD25 prior to administration of Ontak. A testing service for the assay of CD25 expression in tumor biopsy samples is available