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

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

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            Contraindicated (0)

              Serious - Use Alternative (17)

              • bacitracin

                aldesleukin and bacitracin both increase nephrotoxicity and/or ototoxicity. Avoid or Use Alternate Drug. Avoid concurrent use of bacitracin with other nephrotoxic drugs

              • beclomethasone, inhaled

                beclomethasone, inhaled decreases effects of aldesleukin by Other (see comment). Avoid or Use Alternate Drug. Comment: Cordicosteroids may interfere with antitumor effects of biological response modulators.

              • budesonide

                budesonide decreases effects of aldesleukin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid combination because corticosteroids can potentially diminish the antineoplastic effects of aldesleukin.

              • cortisone

                cortisone decreases effects of aldesleukin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid combination because corticosteroids can potentially diminish the antineoplastic effects of aldesleukin.

              • deferiprone

                deferiprone, aldesleukin. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.

              • dexamethasone

                dexamethasone decreases effects of aldesleukin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid combination because corticosteroids can potentially diminish the antineoplastic effects of aldesleukin.

              • fludrocortisone

                fludrocortisone decreases effects of aldesleukin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid combination because corticosteroids can potentially diminish the antineoplastic effects of aldesleukin.

              • hydrocortisone

                hydrocortisone decreases effects of aldesleukin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid combination because corticosteroids can potentially diminish the antineoplastic effects of aldesleukin.

              • methylprednisolone

                methylprednisolone decreases effects of aldesleukin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid combination because corticosteroids can potentially diminish the antineoplastic effects of aldesleukin.

              • metoclopramide intranasal

                aldesleukin, metoclopramide intranasal. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid use of metoclopramide intranasal or interacting drug, depending on importance of drug to patient.

              • mometasone inhaled

                mometasone inhaled decreases effects of aldesleukin by Other (see comment). Avoid or Use Alternate Drug. Comment: Corticosteroids may interfere with antitumor effects of aldesleukin.

              • mometasone topical

                mometasone topical decreases effects of aldesleukin by unspecified interaction mechanism. Avoid or Use Alternate Drug.

              • palifermin

                palifermin increases toxicity of aldesleukin by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

              • prednisolone

                prednisolone decreases effects of aldesleukin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid combination because corticosteroids can potentially diminish the antineoplastic effects of aldesleukin.

              • prednisone

                prednisone decreases effects of aldesleukin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid combination because corticosteroids can potentially diminish the antineoplastic effects of aldesleukin.

              • selinexor

                selinexor, aldesleukin. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.

              • triamcinolone acetonide injectable suspension

                triamcinolone acetonide injectable suspension decreases effects of aldesleukin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid combination because corticosteroids can potentially diminish the antineoplastic effects of aldesleukin.

              Monitor Closely (95)

              • acebutolol

                aldesleukin increases effects of acebutolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • alfuzosin

                aldesleukin increases effects of alfuzosin by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • amifostine

                amifostine, aldesleukin. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration with blood pressure lowering agents may increase the risk and severity of hypotension associated with amifostine. When amifostine is used at chemotherapeutic doses, withhold blood pressure lowering medications for 24 hr prior to amifostine; if blood pressure lowering medication cannot be withheld, do not administer amifostine.

              • amiloride

                aldesleukin increases effects of amiloride by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • amlodipine

                aldesleukin increases effects of amlodipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • asenapine

                aldesleukin increases effects of asenapine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • atenolol

                aldesleukin increases effects of atenolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • benazepril

                aldesleukin, benazepril. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Increases risk of hypotension.

              • betaxolol

                aldesleukin increases effects of betaxolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • bisoprolol

                aldesleukin increases effects of bisoprolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • bosentan

                aldesleukin increases effects of bosentan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • bumetanide

                aldesleukin increases effects of bumetanide by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • candesartan

                aldesleukin increases effects of candesartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • captopril

                aldesleukin, captopril. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs lower blood pressure. Monitor blood pressure.

              • carvedilol

                aldesleukin increases effects of carvedilol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • cenobamate

                cenobamate, aldesleukin. Either increases effects of the other by sedation. Use Caution/Monitor.

              • chlorothiazide

                aldesleukin increases effects of chlorothiazide by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • chlorthalidone

                aldesleukin increases effects of chlorthalidone by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • cholera vaccine

                aldesleukin decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

              • clevidipine

                aldesleukin increases effects of clevidipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • clobazam

                aldesleukin, clobazam. Other (see comment). Use Caution/Monitor. Comment: Concomitant administration can increase the potential for CNS effects (e.g., increased sedation or respiratory depression).

              • clonidine

                aldesleukin increases effects of clonidine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • contrast media (iodinated)

                aldesleukin increases toxicity of contrast media (iodinated) by unknown mechanism. Use Caution/Monitor. Risk of atypical adverse reactions.

              • dichlorphenamide

                dichlorphenamide, aldesleukin. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Both drugs can cause metabolic acidosis.

              • dienogest/estradiol valerate

                aldesleukin will increase the level or effect of dienogest/estradiol valerate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor for potential adverse effects such as nausea, irregular uterine bleeding, breast tenderness and headache.

              • diltiazem

                aldesleukin increases effects of diltiazem by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • doxazosin

                aldesleukin increases effects of doxazosin by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • drospirenone

                aldesleukin increases effects of drospirenone by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • enalapril

                aldesleukin increases effects of enalapril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • eplerenone

                aldesleukin increases effects of eplerenone by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • epoprostenol

                aldesleukin increases effects of epoprostenol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • eprosartan

                aldesleukin increases effects of eprosartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • esmolol

                aldesleukin increases effects of esmolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • ethacrynic acid

                aldesleukin increases effects of ethacrynic acid by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • felodipine

                aldesleukin increases effects of felodipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • fenoldopam

                aldesleukin increases effects of fenoldopam by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • fosinopril

                aldesleukin increases effects of fosinopril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • furosemide

                aldesleukin increases effects of furosemide by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • guanfacine

                aldesleukin increases effects of guanfacine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • hydralazine

                aldesleukin increases effects of hydralazine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • hydrochlorothiazide

                aldesleukin increases effects of hydrochlorothiazide by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • hydroxyurea

                aldesleukin, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.

              • iloprost

                aldesleukin increases effects of iloprost by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • indapamide

                aldesleukin increases effects of indapamide by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • interferon alfa n3

                interferon alfa n3 increases toxicity of aldesleukin by pharmacodynamic synergism. Use Caution/Monitor. Interferon (alfa) may enhance adverse effects which can include risk of myocardial and renal toxicity with concomitant use. Advisable to consider alternative therapy.

              • ioversol

                aldesleukin increases toxicity of ioversol by unknown mechanism. Use Caution/Monitor. Risk of atypical adverse reactions.

              • irbesartan

                aldesleukin increases effects of irbesartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • isradipine

                aldesleukin increases effects of isradipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • labetalol

                aldesleukin increases effects of labetalol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • lisinopril

                aldesleukin increases effects of lisinopril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • losartan

                aldesleukin increases effects of losartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • lurasidone

                aldesleukin increases levels of lurasidone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Concurrent use of weak CYP3A4 inhibitors can theoretically lead to an increased risk of lurasidone-related adverse reactions.

              • maraviroc

                maraviroc, aldesleukin. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of hypotension.

              • methotrexate

                aldesleukin increases levels of methotrexate by decreasing renal clearance. Use Caution/Monitor. May increase myelosupression and hepatotoxicity.

              • metolazone

                aldesleukin increases effects of metolazone by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • metoprolol

                aldesleukin increases effects of metoprolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • midazolam intranasal

                midazolam intranasal, aldesleukin. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.

              • minoxidil

                aldesleukin increases effects of minoxidil by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • moexipril

                aldesleukin increases effects of moexipril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • nadolol

                aldesleukin increases effects of nadolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • nebivolol

                aldesleukin increases effects of nebivolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • nicardipine

                aldesleukin increases effects of nicardipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • nifedipine

                aldesleukin increases effects of nifedipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • nisoldipine

                aldesleukin increases effects of nisoldipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • nitroglycerin rectal

                nitroglycerin rectal, aldesleukin. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Observe for possible additive hypotensive effects during concomitant use. .

              • olmesartan

                aldesleukin increases effects of olmesartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • peginterferon alfa 2b

                peginterferon alfa 2b increases toxicity of aldesleukin by unknown mechanism. Use Caution/Monitor. Interferons may enhance the adverse effects of aldesleukin including myocardial and renal toxicity.

              • penbutolol

                aldesleukin increases effects of penbutolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • peramivir

                aldesleukin increases levels of peramivir by decreasing renal clearance. Use Caution/Monitor. Caution when peramivir coadministered with nephrotoxic drugs.

              • perindopril

                aldesleukin increases effects of perindopril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • phenoxybenzamine

                aldesleukin increases effects of phenoxybenzamine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • phentolamine

                aldesleukin increases effects of phentolamine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • pindolol

                aldesleukin increases effects of pindolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • ponesimod

                ponesimod and aldesleukin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • prazosin

                aldesleukin increases effects of prazosin by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • propranolol

                aldesleukin increases effects of propranolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • quinapril

                aldesleukin increases effects of quinapril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • ramipril

                aldesleukin increases effects of ramipril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • sacubitril/valsartan

                aldesleukin increases effects of sacubitril/valsartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • silodosin

                aldesleukin increases effects of silodosin by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • siponimod

                siponimod and aldesleukin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • sotalol

                aldesleukin increases effects of sotalol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • spironolactone

                aldesleukin increases effects of spironolactone by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • telmisartan

                aldesleukin increases effects of telmisartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • tenofovir DF

                aldesleukin, tenofovir DF. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Use Caution/Monitor.

                aldesleukin increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor.

              • terazosin

                aldesleukin increases effects of terazosin by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • timolol

                aldesleukin increases effects of timolol by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • torsemide

                aldesleukin increases effects of torsemide by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • trandolapril

                aldesleukin increases effects of trandolapril by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • treprostinil

                aldesleukin increases effects of treprostinil by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • triamterene

                aldesleukin increases effects of triamterene by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • valsartan

                aldesleukin increases effects of valsartan by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • verapamil

                aldesleukin increases effects of verapamil by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

              • vilazodone

                aldesleukin increases levels of vilazodone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. No dose adjustment needed with mild CYP3A4 inhibitors.

              • voclosporin

                voclosporin, aldesleukin. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.

              Minor (2)

              • methyclothiazide

                aldesleukin increases effects of methyclothiazide by pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypotension.

              • taurine

                aldesleukin decreases levels of taurine by unspecified interaction mechanism. Minor/Significance Unknown.

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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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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Proleukin intravenous
              -
              22 million unit vial

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              aldesleukin intravenous

              ALDESLEUKIN - INJECTION

              (AL-des-LOO-kin)

              COMMON BRAND NAME(S): Proleukin

              WARNING: Aldesleukin must be given in a hospital setting by a health care professional. It must be used with extreme caution in patients with heart or lung problems.Rarely, this medication can cause capillary leak syndrome (CLS), a serious condition that can sometimes be fatal. If you develop any of the following signs of CLS, tell your doctor right away: swelling, severe dizziness, fainting, irregular heartbeat, chest pain (angina), trouble breathing, signs of kidney problems (such as change in the amount of urine), mental/mood changes, severe stomach/abdominal pain, black stools.Aldesleukin can also make you more likely to get serious infections. Before using this drug, tell your doctor if you currently have any infections. Also, tell your doctor right away if you develop any of the following signs of infection: persistent sore throat, fever.Rarely, this drug may cause a loss of consciousness. If this drug makes you unusually sleepy, stop using it and tell your doctor right away.

              USES: Aldesleukin is used to treat kidney or skin cancer. This medication is the same as a substance that your body normally makes (interleukin-2). In the body, this drug is thought to work by affecting the body's natural defenses (immune system). This effect slows or stops cancer cell growth.

              HOW TO USE: This medication is given by injection into a vein over 15 minutes by a health care professional. It may also be given in other ways as directed by your doctor.This medication is usually given every 8 hours for 5 days in a row. However, your doctor may decide to delay or stop your treatment depending on how you respond to this drug. After this treatment period, you will be given time to rest and recover before getting more of this medication. A course of therapy may include up to 28 doses of this medication. To make sure that you receive each scheduled dose as directed, it is important to keep all of your medical appointments while receiving this medication. Depending on your response, your doctor may decide that a second course would be helpful.Dosage is based on your medical condition, weight, response to treatment, and your side effects.

              SIDE EFFECTS: See also Warning section.Fever, chills, stomach upset, dry skin, muscle stiffness, diarrhea, mouth sores, dizziness, drowsiness, headache, weight gain, nausea, vomiting, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Tell your doctor right away if any of these unlikely but serious side effects occur: swollen belly, muscle pain/weakness, confusion, difficulty speaking, trouble walking, vision changes (including temporary blindness), mental/mood changes (e.g., depression, agitation, hallucinations), unusual bleeding/bruising, thirst, flushing, rapid breathing, symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).Tell your doctor right away if any of these rare but very serious side effects occur: fast heartbeat, yellowing eyes/skin, dark urine, vomit that looks like coffee grounds.Seek immediate medical attention if any of these rare but very serious side effects occur: chest/jaw/left arm pain, seizures.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: See also Warning section.Before using aldesleukin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, heart disease (e.g., fast/irregular heartbeat, recent heart attack, angina), liver disease, lung disease, stomach problems (e.g., ischemic bowel, perforation, bleeding ulcers), high levels of calcium (hypercalcemia), history of organ transplant, seizures.This medication may worsen certain types of immune system disorders (autoimmune and inflammatory type). Before using this medication, tell your doctor or pharmacist if you have any of the following disorders: a certain bowel disease (Crohn's disease), a certain connective tissue disease (scleroderma), thyroid disorders, arthritis, diabetes, a certain muscle/nerve disease (myasthenia gravis), a certain kidney disorder (glomerulonephritis), gallbladder problems (cholecystitis), a certain disease of blood vessels in the brain (cerebral vasculitis).This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).If you are scheduled to have any X-ray or scanning procedure using injectable dye (e.g., iodinated contrast), tell your doctor that you are using this medication.Kidney function declines as you grow older. This medication is removed by the kidneys. Elderly people may be at a greater risk for kidney effects or shortness of breath while using this drug.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Women who may become pregnant should use an effective form of birth control while using this medication. Discuss the use of birth control and the risks and benefits of using this medication with your doctor.It is unknown if this medication passes into breast milk. Because of possible harm to a nursing infant, breast-feeding is not recommended while using this medication. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: blood pressure drugs (including beta blockers such as metoprolol), corticosteroids (e.g., hydrocortisone, methylprednisolone, prednisone), interferon alfa, tamoxifen, drugs that can cause kidney problems (including indomethacin, aminoglycosides such as gentamicin), other anti-cancer medication (e.g., asparaginase, cisplatin, dacarbazine, methotrexate).Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Because there may be breaks in treatment, it is important to keep all medical/infusion appointments.Your doctor should check your heart, lungs, kidneys, liver, and mental state before you start treatment with this medication. Laboratory and/or medical tests (e.g., complete blood counts, kidney/liver/lung function, chest X-ray, blood pressure, pulse, mental status, weight, urine output) should also be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

              MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

              STORAGE: Not applicable. This medication is given in a hospital and will not be stored at home.

              MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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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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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.