HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Ontak safely and effectively. See full prescribing information for Ontak.
ONTAK® (denileukin diftitox)
Injection for intravenous infusion
Initial U.S. Approval: 1999
WARNING: SERIOUS INFUSION REACTIONS, CAPILLARY LEAK SYNDROME AND LOSS OF VISUAL ACUITY.
See full prescribing information for complete boxed warning.
The following adverse reactions have been reported:
Serious and fatal infusion reactions. Administer Ontak in a facility equipped and staffed for cardiopulmonary resuscitation. (5.1)
Capillary leak syndrome resulting in death. (5.2)
Loss of visual acuity and color vision. (5.3)
INDICATIONS AND USAGE
Ontak is a CD25-directed cytotoxin 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. (1)
DOSAGE AND ADMINISTRATION
Premedicate with an antihistamine and acetaminophen prior to each Ontak infusion.
Administer at 9 or 18mcg/kg/day by intravenous infusion over 30 to 60minutes for 5consecutive days every 21days for 8cycles. (2.1, 2.2)
DOSAGE FORMS AND STRENGTHS
Solution in a single-use vial containing 150mcg/mL (300mcg in 2mL). (3)
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Infusion reactions: Immediately stop and permanently discontinue Ontak for serious infusion reactions. Monitor patients following infusion. (5.1)
Capillary leak syndrome: Monitor weight, edema, blood pressure and serum albumin levels. (5.2)
Loss of Visual Acuity and Color Vision: Monitor visual acuity and color vision. (5.3)
Laboratory Tests: Monitor serum albumin levels prior to the initiation of each treatment course. Delay administration of Ontak until serum albumin levels are at least 3.0g/dL. (5.5)
ADVERSE REACTIONS
The most common adverse reactions (≥20%) were pyrexia, nausea, fatigue, rigors, vomiting, diarrhea, headache, peripheral edema, cough, dyspnea and pruritus. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Eisai Inc. at 1-888-274-2378 (by fax 1-201-746-3207) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pregnancy: No human or animal data. Use only if clearly needed. (8.1)
Nursing Mothers: Discontinue drug or nursing taking into consideration importance of drug to mother. (8.3)
See 17 for PATIENT COUNSELING INFORMATION 
Revised: 08/2011
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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed 
WARNING: SERIOUS INFUSION REACTIONS, CAPILLARY LEAK SYNDROME AND LOSS OF VISUAL ACUITY.
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Schedule and Administration
2.2 Preparation and Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Infusion Reactions
5.2 Capillary Leak Syndrome
5.3 Visual Loss
5.4 CD25 Tumor Expression and eva luation
5.5 Laboratory Monitoring/Hypoalbuminemia
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
6.2 Immunogenicity
6.3 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregna