aldesleukin (Rx)

Brand and Other Names:Interleukin 2, Proleukin
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 22M International Units/vial
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Metastatic Renal Cell Carcinoma

600,000 International Units/kg (0.037 mg/kg) IV q8hr infused over 15 minutes for a maximum 14 doses, THEN 

9 days of rest, followed by a maximum of 14 more doses

Retreatment: Evaluate after 4 weeks, advisable only if tumor shrinkage and no retreatment contraindications (see package insert for details)

Metastatic Melanoma

600,000 International Units/kg (0.037 mg/kg) IV q8hr infused over 15 minutes for a maximum of 14 doses, THEN 

9 days of rest, followed by a maximum of 14 more doses

Retreatment: Evaluate after 4 weeks, advisable only if tumor shrinkage and no retreatment contraindications (see package insert for details)

Non-Hodgkin Lymphoma (Orphan)

Designated orphan indication for treatment of non-Hodgkin lymphoma

Orphan indication sponsor

  • Prometheus Laboratories, Inc; 9410 Carroll Park Drive; San Diego, CA 92121

Primary Immunodeficiency (Orphan)

Designated orphan indication for treatment of primary immunodeficiency disease associated with T-cell defects

Orphan indication sponsor

  • Prometheus Laboratories, Inc; 9410 Carroll Park Drive; San Diego, CA 92121

Monitor

CBC, chemistries, ABGs, pulmonary function

Safety and efficacy not established

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Interactions

Interaction Checker

and aldesleukin

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Hypotension (71%)

            Diarrhea (67%)

            Oliguria (63%)

            Chills (52%)

            Vomiting (50%)

            Dyspnea (43%)

            Rash (42%)

            Bilirubinemia (40%)

            Thrombocytopenia (37%)

            Nausea (35%)

            Confusion (34%)

            Increased creatinine (33%)

            Fever (29%)

            Anemia (29%)

            Peripheral Edema (28%)

            Malaise (27%)

            Pruritus (24%)

            Asthenia (23%)

            Respiratory/lung disorders (11-24%)

            Increased hepatic enzymes (10-23%)

            Tachycardia (23%)

            Somnolence (22%)

            Stomatitis (22%)

            Anorexia (20%)

            Nausea and vomiting (19%)

            Exfoliative dermatitis (18%)

            Leukopenia (16%)

            Weight gain (16%)

            Edema (15%)

            Infection (13%)

            Vasodilation (13%)

            Supraventricular tachycardia (12%)

            Pain (12%)

            Acidosis (12%)

            Anxiety (12%)

            Dizziness (11%)

            Hypocalcemia (11%)

            Abdominal pain (11%)

            Cough (11%)

            1-10%

            Arrhythmia (10%)

            Rhinitis (10%)

            <1%

            Immunogenicity: Low titers of anti-aldesleukin antibodies were detected in 66-74% of patients; neutralizing antibodies detected in 1 patient

            Postmarketing Reports

            Blood and lymphatic system: neutropenia, febrile neutropenia, eosinophilia, lymphocytopenia

            Cardiac: Cardiomyopathy, cardiac tamponade Endocrine: hyperthyroidism

            Gastrointestinal: Gastritis, intestinal obstruction, colitis

            General and administration site conditions: Injection site necrosis

            Hepatobiliary: Hepatitis, hepatosplenomegaly, cholecystitis

            Immune system: Anaphylaxis, angioedema, urticaria

            Infections and infestations: Pneumonia (bacterial, fungal, viral), fatal endocarditis, cellulitis

            Musculoskeletal and connective tissue: Myopathy, myositis, rhabdomyolysis

            Nervous system: Cerebral lesions, encephalopathy, extrapyramidal syndrome, neuralgia, neuritis, demyelinating neuropathy

            Psychiatric: Insomnia

            Vascular: Hypertension, fatal subdural and subarachnoid hemorrhage, cerebral hemorrhage, retroperitoneal hemorrhage

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            Warnings

            Black Box Warnings

            The drug should be administered under the supervision of an experienced cancer chemotherapy health care provider in a hospital setting with ICU care

            High-dose aldesleukin therapy has been associated with capillary leak syndrome (CLS), resulting in hypotension and reduced organ perfusion, which may be severe and can result in death

            Use with extreme caution in patients with history of prior cardiac or pulmonary disease

            Impaired neutrophil function is associated with treatment. Patients are at risk for sepsis, bacterial endocarditis, and central line-related gram-positive infections.

            Withhold therapy for patients developing moderate-to-severe lethargy or somnolence. Continued treatment may result in coma.

            Contraindications

            Hypersensitivity, abnormal thallium stress test or pulmonary function test

            Organ allografts

            Retreatment for those who experienced complications of drug-induced capillary leak syndrome

            • Sustained VTach (=5 beats), Cardiac arrhythmias not controlled or unresponsive to management
            • Chest pain with ECG changes, consistent with angina/MI; Cardiac tamponade
            • Intubation for >72 hr; renal failure requiring dialysis >72 hr
            • Coma or toxic psychosis lasting >48 hours
            • Repetitive or difficult to control seizures
            • Bowel ischemia/perforation; GI bleeding requiring surgery

            Cautions

            History of cardiac or pulmonary disease

            See Package Insert for retreatment guidelines & contraindications

            May exacerbate autoimmune disease

            Risk of capillary leak syndrome

            Risk of reduced neutrophil chemotaxis, resulting in sepsis/infection risk, use prophylaxis if warranted

            Hypotension is dose-limiting

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            Pregnancy & Lactation

            Pregnancy Category: C

            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 human interleukin-2; stimulates lymphokines-activated killer cells and tumor-infiltrating lymphocytes cells following the interaction between malignant cells and the immune system

            Cytolytic for a subset of lymphocytes; promotes differentiation, proliferation and recruitment of B and T cells, thymocytes and natural killer cells

            Metabolism

            Kidneys

            Distribution

            Vd: 4-7 L

            Elimination

            Half-Life: 85 minutes

            Clearance: 268 mL/min

            Excretion: Urine

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            Administration

            IV Incompatibilities

            Additive: NS

            Y-site: dopamine(?), fluorouracil, ganciclovir, KCl(?), lorazepam, pentamidine, prochlorperazine, promethazine

            IV Compatibilities

            Y-site: amikacin, amphotericin B, Ca-gluconate, diphenhydramine, fluconazole, foscarnet, gentamicin, heparin, MgSO4, metoclopramide, morphine SO4, ondansetron, piperacillin, ranitidine, thiethylperazine, ticarcillin, tobramycin, TMP-SMX, vancomycin

            IV Preparation

            Concentrations <30 mcg/mL OR concentrations between 30-70 mcg/mL for infusion via ambulatory infusion pump require addition of albumin

            Reconstitute/dilute in D5W only; incompatible with sodium chloride solutions or BWI

            Gently swirl, do not shake

            IV Administration

            Infuse over 15 minutes

            Do not use in-line filter

            Vascular Leak Syndrome Management

            If actual body weight increases 10% above baseline, or rales or rhonchi are audible

            • Administer furosemide at dosage determined by patient response
            • Administer dopamine 2-4 mcg/kg/min to maintain renal blood flow and urine output
            • If patient has dyspnea at rest, give supplemental oxygen by face-mask

            If patient has severe respiratory distress: intubate patient and provide mechanical ventilation; give ranitidine 50 mg IV q8-12hr as prophylaxis against stress ulcers

            Storage

            Store lyophilized powder at 2-8°C (36-46°F)

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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