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Indication

ONTAK® (denileukin difitox) 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.

Important Safety Information

The following adverse reactions have been reported:
  • Serious and fatal infusion reactions. Administer ONTAK® in a facility equipped and staffed for cardiopulmonary resuscitation. Immediately stop and permanently discontinue ONTAK® for serious infusion reactions.
  • Capillary leak syndrome resulting in death. Monitor weight, edema, blood pressure and serum albumin levels prior to and during ONTAK® treatment.
  • Loss of visual acuity and color vision.

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% of 234 ONTAK®-treated patients across 3 clinical studies. Serious infusion reactions were reported in 8.1% of patients. There have been post-marketing reports of infusion reactions resulting in death. For patients completing at least 4 courses of ONTAK® treatment in a placebo-controlled trial, the incidence of infusion reactions was lower in the third and fourth cycles as compared to the first and second cycles of ONTAK®.

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 in clinical studies; one-third required hospitalization or medical intervention to prevent hospitalization. There are 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 and hypotension (including orthostatic changes). Monitor serum albumin levels prior to each course of therapy and more often as clinically indicated. Withhold ONTAK® for serum albumin levels less than 3 g/dL.

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.

Hepatobilary Disorders

Increase in ALT/AST from baseline occurred in 84% of ONTAK®-treated patients. The majority of these elevations occurred during either the first or second cycle, resolved without medical intervention, and did not require discontinuation of ONTAK®.

Pregnancy and Lactation

ONTAK® should be given to a pregnant woman only if clearly needed and should not be used in women who are nursing.

Most Common Adverse Reactions

In clinical studies (n=234), the most common adverse reactions in ONTAK®-treated patients (≥20%) were pyrexia, nausea, fatigue, rigors, vomiting, diarrhea, headache, peripheral edema, cough, dyspnea and pruritus. The most common serious adverse reactions were capillary leak syndrome (11.1%), infusion reactions (8.1%), and visual changes including loss of visual acuity (4%). ONTAK® was discontinued in 28.2% of patients due to adverse reactions.

Please see the ONTAK® full Prescribing Information including Boxed WARNINGS and additional important safety information.



Eisai cannot guarantee payment of any claim. Coding, coverage, and reimbursement may vary significantly by payor, plan, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payors following the receipt of claims. For additional information, customers should consult with their payors for all relevant coding, reimbursement, and coverage requirements. It is the sole responsibility of the provider to select the proper code and ensure the accuracy of all claims used in seeking reimbursement. All services must be medically appropriate and properly supported in the patient medical record.

This information is intended for use by our healthcare professionals in the United States only. Eisai Inc. recognizes the Internet is a global communications medium; however, laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here is not appropriate for use outside the United States. This site contains information about products that may have different product labeling in different countries.

ONTAK® is a registered trademark of Eisai Inc.

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This site was last modified on : December 19, 2011 at 5:45pm ET