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Ontak Generic Name & Formulations
Legal Class
Rx
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
Manufacturer
Ontak Indications
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
Adult
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.
Children
Not recommended.
Ontak Contraindications
Not Applicable
Ontak Boxed Warnings
Boxed Warning
Serious infusion reactions. Capillary leak syndrome. Loss of visual acuity.
Ontak Warnings/Precautions
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
Notes
Testing considerations: CD25 expression
Ontak Patient Counseling
See Literature
