Monograph Details
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Neoplasms
> Miscellaneous oncology agents
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ONTAK |
| Manufacturer |
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Eisai Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Interleukin 2-diphtheria toxin fusion protein. |
| Generic Name |
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Denileukin diftitox 150micrograms/mL; soln for IV infusion after thawing and dilution. |
| Indications |
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Persistent or recurrent cutaneous T-cell lymphoma in which malignant cells express the CD25 component of the IL-2 receptor. |
| Children |
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Not recommended. |
| Adults |
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Give by IV infusion over at least 15 minutes (max 80 minutes). 9 or 18micrograms/kg/day for 5 consecutive days every 21 days. Interrupt or decrease infusion rate if severe hypersensitivity reactions occur; may require IV antihistamine, corticosteroid and epinephrine. |
| Precautions |
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Ensure CD25 expression before starting therapy. Monitor for signs/symptoms of vascular leak syndrome (hypotension, edema, hypoalbuminemia), and for infections. Pre-existing cardiovascular disease. Monitor serum albumin level, blood counts and chemistry, renal and hepatic function prior to therapy and weekly thereafter; delay treatment until serum albumin ≥3g/dL. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Adverse Reactions |
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Hypersensitivity reactions (eg, hypotension, back pain, dyspnea, vasodilation, rash, chest pain, tachycardia, dysphagia, syncope, anaphylaxis), fever, hypoalbuminemia, GI upset, asthenia, infection, elevated transaminases, edema, headache, visual impairment, inj site reactions; vascular leak syndrome, thrombosis. |
| How Supplied |
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Single-use vials (2mL)—6 |
| Additional Resources |
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• Related Prescribing Note |
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