denileukin (Discontinued)Brand and Other Names:Ontak

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 150mcg/mL
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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

Safety and efficacy not established

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Interactions

Interaction Checker

denileukin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse 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

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            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

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            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

            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.

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            Pharmacology

            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

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            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

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