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.
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