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(Interleukin-2; IL-2)

Aldesleukin (Proleukin)
Interleukin-2 (Proleukin)
IL-2 (Proleukin)
(al-des- LOO-kin)
Pregnancy Category: C Proleukin (Rx)

Classification: Antineoplastic, miscellaneous

See Also: See also Antineoplastic Agents.

Action/Kinetics: Is a human interleukin-2 (IL-2) product produced by recombinant DNA technology, The recombinant form differs from natural IL-2 in that aldesleukin is not glycosylated, the molecule has no N-terminal alanine, the molecule has serine substituted for cysteine at amino acid position 125, and the aggregation state of aldesleukin may be different from that of native IL-2. However, aldesleukin possesses the biologic activity of human native IL-2. Drug effects include activation of cellular immunity with profound lymphocytosis, eosinophilia, and thrombocytopenia; the production of cytokines, including tumor necrosis factor, IL-1, and gamma-interferon; and inhibition of tumor growth. The exact mechanism of action of aldesleukin is not known but may induce the proliferation of natural killer and cytotoxic T cells, which recognize and fight tumor-specific antigens located on the surface of malignant cells. High plasma levels reached after a short IV infusion; rapidly distributed to the extravascular, extracellular space. Rapidly cleared from the circulation by both glomerular filtration and peritubular extraction; metabolized in the kidneys with little or no active form excreted through the urine. t 1/2, distribution: 13 min; t 1/2, elimination: 85 min.

Uses: Metastatic renal cell carcinoma in adults 18 years of age and older. Metastatic melanona. Investigational: Kaposi's sarcoma in combination with AZT, metastatic melanoma in combination with low-dose cyclophosphamide, colorectal cancer and non-Hodgkin's lymphoma often in combination with lymphokine-activated killer cells.

Contraindications: Hypersensitivity to IL-2 or any components of the product. Abnormal thallium stress test or pulmonary function tests. Organ allografts. Use in either men or women not practicing effective contraception. Lactation.
Retreatment is contraindicated in those who have experienced the following during a previous course of therapy: sustained ventricular tachycardia; uncontrolled or unresponsive cardiac rhythm disturbances; recurrent chest pain with ECG changes that are consistent with angina or MI; intubation required for more than 72 hr; pericardial tamponade; renal dysfunction requiring dialysis for more than 72 hr; coma or toxic psychosis lasting more than 48 hr; seizures that are repetitive or difficult to control; ischemia or perforation of the bowel; and GI bleeding requiring surgery.

Special Concerns: Symptoms may worsen in clients with unrecognized or untreated CNS metastases. Use of medications known to be nephrotoxic or hepatotoxic may further increase toxicity to the kidney and liver caused by aldesleukin. May increase the risk of allograft rejection in transplant clients. Safety and efficacy have not been established in children less than 18 years of age.

Side Effects: Side effects are frequent, often serious, and sometimes fatal. Most clients will experience fever, chills, rigors, pruritus, and GI side effects. The frequency and severity of side effects are usually dose-related and schedule-dependent. Incidence of side effects is greater in PS 1 clients than in PS 0 clients. The side effects listed have an incidence of 1% or greater.
Capillary leak syndrome (CLS): Results from extravasation of plasma proteins and fluid into the extracellular space with loss of vascular tone. This results in a drop in mean arterial BP within 2-12 hr after the start of treatment and reduced organ perfusion that may be severe and result in death. CLS causes hypotension, hypoperfusion, and extravasation that leads to edema and effusion. CLS may be associated with supraventricular and ventricular arrhythmias, MI angina, respiratory insufficiency requiring intubation, GI bleeding or infarction, renal insufficiency, and changes in mental status.

CV: Hypotension (sometimes requiring vasopressor therapy), sinus tachycardia, arrhythmias (atrial, junctional, supraventricular, ventricular), bradycardia, PVCs, premature atrial contractions, myocardial ischemia, MI, cardiac arrest, CHF myocarditis, endocarditis, gangrene, stroke, pericardial effusion, thrombosis. Respiratory: Pulmonary congestion, dyspnea, pulmonary edema, respiratory failure tachypnea, pleural effusion, wheezing, apnea, pneumothorax, hemoptysis. GI: N&V, diarrhea, stomatitis, anorexia, GI bleeding (sometimes requiring surgery), dyspepsia, constipation, intestinal perforation intestinal ileus, pancreatitis. CNS: Changes in mental status (may be an early indication of bacteremia or early bacterial sepsis), dizziness, sensory dysfunction, disorders of special senses (speech, taste, vision), syncope, motor dysfunction, coma, seizure. GU: Oliguria or anuria, proteinuria, hematuria, dysuria, impaired renal function requiring dialysis, urinary retention, urinary frequency. Hepatic: Jaundice, ascites, hepatomegaly. Hematologic: Anemia, thrombocytopenia, leukopenia, coagulation disorders, leukocytosis, eosinophilia. Dermatologic: Pruritus, erythema, rash, dry skin, exfoliative dermatitis, purpura, petechiae, urticaria, alopecia. Musculoskeletal: Arthralgia, myalgia, arthritis, muscle spasm. Electrolyte and other disturbances: Hypomagnesemia, acidosis, hypocalcemia, hypophosphatemia, hypokalemia, hyperuricemia, hypoalbuminemia, hypoproteinemia, hyponatremia, hyperkalemia, alkalosis, hypoglycemia, hyperglycemia, hypocholesterolemia, hypercalcemia, hypernatremia, hyperphosphatemia. Miscellaneous: Fever, chills, pain (abdominal, chest, back), fatigue, malaise, weakness, edema, infection (including the injection site, urinary tract, catheter tip, phlebitis, sepsis), weight gain or weight loss, headache, conjunctivitis, reactions at the injection site, allergic reactions, hypothyroidism.

Laboratory Test Alterations: BUN, bilirubin, serum creatinine, transaminase, alkaline phosphatase. See also Electrolyte and other disturbances under Side Effects.

Overdose Management: Symptoms: See Side Effects. Treatment: Side effects will usually reverse if the drug is stopped, especially because the serum half-life is short. Continuing toxicity is treated symptomatically. Life-threatening side effects have been treated by the IV administration of dexamethasone (which may result in loss of the therapeutic effectiveness of aldesleukin).

Drug Interactions: Aminoglycosides / Risk of kidney toxicity Antihypertensives / Potentiate hypotension seen with aldesleukin Asparaginase / Risk of hepatic toxicity Cardiotoxic agents / Risk of cardiac toxicity Corticosteroids / Concomitant use may antitumor effectiveness of aldesleukin (although corticosteroids aldesleukin side effects) Cytotoxic chemotherapy / Risk of myelotoxicity Doxorubicin / Risk of cardiac toxicity Hepatotoxic drugs / Risk of liver toxicity Indinavir / Plasma levels of indinavir due to breakdown by liver Indomethacin / Risk of kidney toxicity Methotrexate / Risk of hepatic toxicity Myelotoxic agents / Risk of myelotoxicity Nephrotoxic agents / Risk of kidney toxicity

How Supplied: Powder for injection: 22 million IU

?Intermittent IV Infusion Metastatic renal cell carcinoma in adults.
Each course of treatment consists of two 5-day treatment cycles separated by a rest period. Adults: 600,000 IU/kg (0.037 mg/kg) given q 8 hr by a 15-min IV infusion for a total of 14 doses. Following 9 days of rest, repeat schedule for another 14 doses, for a maximum of 28 doses per course. NOTE: Due to toxicity, clients may not be able to receive all 28 doses (median number of doses given is 20).
Retreatment for metastatic renal cell carcinoma.
Evaluate for a response about 4 weeks after completion of a course of therapy and again just prior to the start of the next treatment course. Give additional courses only if there is evidence of some tumor shrinkage following the last course and retreatment is not contraindicated (see preceding Contraindications). Separate each treatment course by at least 7 weeks from the date of hospital discharge.

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