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denileukin diftitox (Ontak, Lymphir)
Tradenames: Ontak, Lymphir.
Cytotoxic recombinant protein consisting of diphtheria toxin combined with fragments of human interleukin-2 (IL-2).
Indications:
1) FDA approved for treatment of patients with persistent or recurrent CD25 positive cutaneous T-cell lymphoma
- relapsed/refractory cutaneous T-cell lymphoma [3]
2) B-cell lymphoma (in clinical trials)
3) Hodgkin's disease (in clinical trials)
Dosage:
1) 9-18 ug/kg/day
2) 6 cycles of treatment (4 months)
Monitor:
1) testing for CD25 antigen
2) complete blood count (CBC) weekly
3) chemistry panel including:
a) renal function tests
b) liver function tests
c) serum albumin
Adverse effects:
1) 21% of patients require hospitalization due to adverse effects
2) fever
3) vascular leak syndrome
- pre-existing cardiovascular disorder & low serum albumin predispose
4) gastrointestinal toxicity
5) acute hypersensitivity (69%)
6) flu-like syndrome (91%)
7) infection (48%)
8) loss of visual acuity [3]
a) usually with loss of color vision
b) persistent visual impairment
Mechanism of action:
1) binds to activated lymphocytes & macrophages
2) may compromise immune function
General
recombinant protein; chimer
antineoplastic immunomodulator
References
- Kaiser Permanente Northern California Regional Drug
Formulary, Update 9/99
- Frankel AE et al, Clin Cancer Res 9:3555, 2003
PMID: 14506141
- FDA Medwatch
http://www.fda.gov/medwatch/safety/2006/safety06.htm#ontak
- Bankhead C
IL-2 Receptor-Targeted Therapy Approved for Relapsed/Refractory CTCL.
New iteration of denileukin diftitox led to objective responses in 36%
of pretreated patients.
MedPage Today, August 8, 2024
https://www.medpagetoday.com/hematologyoncology/lymphoma/111426