Generic Name and Formulations:
Denileukin diftitox 150mcg/mL; soln for IV infusion after thawing and dilution.
Indications for ONTAK:
Persistent or recurrent cutaneous T-cell lymphoma in which malignant cells express the CD25 component of the IL-2 receptor.
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.
Serious infusion reactions. Capillary leak syndrome. Loss of visual acuity.
Ensure CD25 expression before starting therapy. Have resuscitative equipment available during administration. Permanently discontinue if serious infusion reactions occur. Monitor for signs/symptoms of capillary leak syndrome (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 (Cat.C). Nursing mothers: not recommended.
Interleukin 2-diphtheria toxin fusion protein.
Fever, fatigue, rigors, GI upset, headache, edema, cough, dyspnea, pruritus, rash, hypotension, back pain, myalgia, chest pain, tachycardia, hypoalbuminemia, asthenia, elevated transaminases; capillary leak syndrome (may be fatal), serious infusion reactions, visual impairment.
Testing considerations: CD25 expression
Single-use vials (2mL)—6