• Leukemias, lymphomas, and other hematologic cancers

Ontak Generic Name & Formulations

General Description

Denileukin diftitox 150mcg/mL; soln for IV infusion after thawing and dilution.

Pharmacological Class

Interleukin 2-diphtheria toxin fusion protein.

How Supplied

Single-use vials (2mL)—6


Ontak Indications


Persistent or recurrent cutaneous T-cell lymphoma in which malignant cells express the CD25 component of the IL-2 receptor.

Ontak Dosage and Administration


Premedicate with an antihistamine or acetaminophen prior to each infusion. Give by IV infusion over 30–60mins. 9 or 18mcg/kg per day for 5 consecutive days every 21 days for 8 cycles.


Not recommended.

Ontak Contraindications

Not Applicable

Ontak Boxed Warnings

Boxed Warning

Serious infusion reactions. Capillary leak syndrome. Loss of visual acuity.

Ontak Warnings/Precautions


Ensure CD25 expression before starting therapy. Have resuscitative equipment available during administration. Permanently discontinue if ≥Grade 3 infusion reactions occur. Monitor for capillary leak syndrome (eg, hypotension, edema, hypoalbuminemia) and weight gain. Monitor serum albumin levels prior to each treatment course; withhold treatment if serum albumin <3g/dL. Monitor visual acuity and color vision. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential to use effective contraception during and for ≥7 days after the last dose. Nursing mothers: not recommended (during and for 7 days after the last dose).

Ontak Pharmacokinetics

See Literature

Ontak Interactions

Ontak Adverse Reactions

Adverse Reactions

Pyrexia, fatigue, rigors, GI upset, headache, peripheral edema, cough, dyspnea, pruritus, rash, hypotension, back pain, myalgia, chest pain, tachycardia, hypoalbuminemia, asthenia, elevated transaminases.

Ontak Clinical Trials

See Literature

Ontak Note


Testing considerations: CD25 expression

Ontak Patient Counseling

See Literature