Dosing and uses of Ontak (denileukin)
Adult dosage forms and strengths
injectable solution
- 150mcg/mL
Cutaneous T-Cell Lymphoma
This product was discontinued in January 2014
Malignant cells express CD25 component of IL-2 receptor
9-18 mcg/kg IV (infuse over 30-60 minutes) qDay x 5 days; repeat q21Days
Peripheral T-Cell Lymphoma (Orphan)
Orphan indication sponsor: Eisai, Inc; 155 Tice Blvd; Woodcliff Lake, NJ 5271
Monitor
CBC, LFTs, albumin
Renal Impairment
Not studied
Hepatic Impairment
Not studied
Pediatric dosage forms and strengths
Safety and efficacy not established
Ontak (denileukin) adverse (side) effects
>10%
Flu-like syndrome (85%)
Inc AST/ALT (84%)
Hypoalbuminemia (83%)
Fever/chills (81%)
Asthenia (66%)
N/V (64%)
Infection (48%)
Edema (47%)
Anorexia (36%)
Rash (34%)
Capillary leak syndrome (33%)
Dyspnea (29%)
Headache (26%)
Chest pain (24%)
Diarrhea (22%)
Vasodilation (22%)
Myalgia (20%)
Cough (18%)
Hypocalcemia (17%)
Hypotension (16%)
Pain (13%)
URI (13%)
Dyspnea (11%)
Tachycardia (12%)
Hematuria (10%)
1-10%
Constipation (9%)
Thrombocytopenia (8%)
Injection site reaction (8%)
Dyspepsia (7%)
Arrhythmia (6%)
Dysphagia (6%)
Hypertension (6%)
Loss of visual acuity (4%)
Creatinine increased (3%)
Postmarketing Reports
Acute renal insufficiency
Hyper/hypothyroidism
Pancreatitis
Toxic epidermal necrolysis
Warnings
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
Contraindications
Hypersensitivity to denileukin, aldesleukin, or diphtheria toxin
Cautions
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 and 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
Pregnancy categories
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.
Pharmacology of Ontak (denileukin)
Mechanism of action
Recombinant chimeric diphtheria toxin/interleukin-2 protein with affinity for IL-2 receptors
Pharmacokinetics
Half-Life: 70-80 min
Vd: 0.06-0.09 L/kg
Metabolism: Liver
Clearance: 1.5-2.0 mL/min/kg
Administration
IV Incompatibilities
Do not use glass syringes or containers
IV Preparation
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
IV Administration
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
Storage
Store frozen; cannot be refrozen
