Brand and Other Names:Ontak
- Classes: Antineoplastics, Other
Dosing & Uses
Dosage Forms & Strengths
Cutaneous T-Cell Lymphoma
This product was discontinued in January 2014
Malignant cells express CD25 component of IL-2 receptor
Peripheral T-Cell Lymphoma (Orphan)
Orphan indication sponsor: Eisai, Inc; 155 Tice Blvd; Woodcliff Lake, NJ 5271
CBC, LFTs, albumin
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Flu-like syndrome (85%)
Inc AST/ALT (84%)
Capillary leak syndrome (33%)
Chest pain (24%)
Injection site reaction (8%)
Loss of visual acuity (4%)
Creatinine increased (3%)
Acute renal insufficiency
Toxic epidermal necrolysis
Black Box Warnings
Serious and fatal infusion reactions may occur. Administer denileukin diftitox in a facility equipped and staffed for cardiopulmonary resuscitation. Immediately stop and permanently discontinue the drug for serious infusion reactions.
Capillary leak syndrome resulting in death may occur. Monitor weight, edema, blood pressure, and serum albumin levels prior to and during denileukin diftitox treatment.
Loss of visual acuity and color vision reported
Hypersensitivity to denileukin, aldesleukin, or diphtheria toxin
Risk of potentially irreversible visual impairment (loss of visual acuity & color vision)
Risk of potentially fatal capillary leak syndrome
May develop immunogenicity
Monitor for infection (may inhibit immune function)
Risk of hypoalbuminemia-do not administer until serum albumin at least 3 g/day
Incidence of adverse events decreases after first 2 treatment courses
Pregnancy & Lactation
Pregnancy Category: Not available. It is not known whether denileukin can cause fetal harm when administered to a pregnant woman.
Lactation: excretion in milk unknown/not recommended
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Recombinant chimeric diphtheria toxin/interleukin-2 protein with affinity for IL-2 receptors
Half-Life: 70-80 min
Vd: 0.06-0.09 L/kg
Clearance: 1.5-2.0 mL/min/kg
Do not use glass syringes or containers
Must be brought to room temp before preparing the dose
Do not heat vials
Thaw in refrigerator not to exceed 24 hr or at room temp for 1-2 hr
Avoid vigorous agitation
Solution may be mixed by gentle swirling
Use within 6 hr
Infuse over at least 15 min, do not infuse through filter
Do not give as bolus
Observe patient closely for symptoms of hypersensitivity
If a patient experiences a reaction, evaluate severity of reaction & either reduce the rate or discontinue the infusion
Resuscitation equipment must be readily available
Delay therapy if serum albumin is <3 g/dL
Store frozen; cannot be refrozen