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Does Proleukin cause side effects?
Proleukin stimulates your body’s own immune system to attack metastatic kidney cancer—a process that produces some side effects. Nearly all drugs can produce side effects, which generally occur when a person has a reaction to a drug or its ingredients. Like most immunotherapies, some side effects can be serious and sometimes life-threatening. If necessary, Proleukin can be stopped at any time to help manage them.
Every person with metastatic kidney cancer has a unique experience, and most treatment-related side effects should resolve 2 to 3 days after stopping treatment.
Everyone is different, and side effects during treatment can be mild, moderate, or severe. With Proleukin, common side effects that may occur during treatment include*:
The most serious (life-threatening severity) adverse drug reactions can include decreased or no amount of urine production, low blood pressure, breathing problems, abnormal liver function tests, coma, diarrhea, and fast heartbeat.
During treatment at the hospital that specializes in Proleukin treatment, healthcare professionals will monitor your vital signs, heart rate, blood tests, oxygen in the lungs, fluid intake and output—and your overall well-being—in an effort to limit the severity of the side effects.
Looking for signs of a rapid or irregular heart rate, or high blood pressure.
Checking that these organs are working properly.
Watching for shortness of breath.
Monitoring to check function of your organs, check for infection, as well as other components in the blood.
The experienced healthcare professionals will follow treatment-specific guidelines for managing the side effects you experience, and will do everything they can to keep you as comfortable as possible throughout treatment. They can also stop your treatment with Proleukin, if needed. Every person with metastatic kidney cancer has a unique experience and most treatment-related side effects should resolve 2 to 3 days after stopping treatment.
Talk with your healthcare professional
If you have additional questions or concerns about potential side effects, you can talk to your healthcare professional about whether Proleukin may be right for you. You can also ask about what to expect at the hospital that specializes in Proleukin treatment, including:
*These are not all of the possible side effects associated with Proleukin. Ask your healthcare professional for more information.
Proleukin® (aldesleukin) is indicated for the treatment of adults with metastatic melanoma (mM) and metastatic renal cell carcinoma (mRCC).
Summary of Important Safety Information for Proleukin® (aldesleukin) for injection, for intravenous infusion.
Proleukin® (aldesleukin) is indicated for the treatment of adults with metastatic renal cell carcinoma (mRCC) and metastatic melanoma (mM).
Summary of Important Safety Information for Proleukin® (aldesleukin) for injection, for intravenous infusion.
WARNINGS
Therapy with Proleukin® (aldesleukin) should be restricted to patients with normal cardiac and pulmonary functions as defined by thallium stress testing and formal pulmonary function testing. Extreme caution should be used in patients with a normal thallium stress test and a normal pulmonary function test who have a history of cardiac or pulmonary disease.
Proleukin should be administered in a hospital setting under the supervision of a qualified physician experienced in the use of anticancer agents. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available.
Proleukin administration has been associated with capillary leak syndrome (CLS) which is characterized by a loss of vascular tone and extravasation of plasma proteins and fluid into the extravascular space. CLS results in hypotension and reduced organ perfusion which may be severe and can result in death. CLS may be associated with cardiac arrhythmias (supraventricular and ventricular), angina, myocardial infarction, respiratory insufficiency requiring intubation, gastrointestinal bleeding or infarction, renal insufficiency, edema, and mental status changes.
Proleukin treatment is associated with impaired neutrophil function (reduced chemotaxis) and with an increased risk of disseminated infection, including sepsis and bacterial endocarditis. Consequently, preexisting bacterial infections should be adequately treated prior to initiation of Proleukin therapy. Patients with indwelling central lines are particularly at risk for infection with gram positive microorganisms. Antibiotic prophylaxis with oxacillin, nafcillin, ciprofloxacin, or vancomycin has been associated with a reduced incidence of staphylococcal infections.
Proleukin administration should be withheld in patients developing moderate to severe lethargy or somnolence; continued administration may result in coma.
INDICATIONS AND USAGE
Proleukin® (aldesleukin) is indicated for the treatment of adults with metastatic renal cell carcinoma (metastatic RCC).
Proleukin is indicated for the treatment of adults with metastatic melanoma.
Careful patient selection is mandatory prior to the administration of Proleukin.
Evaluation of clinical studies to date reveals that patients with more favorable ECOG performance status (ECOG PS 0) at treatment initiation respond better to Proleukin, with a higher response rate and lower toxicity. Therefore, selection of patients for treatment should include assessment of performance status.
Experience in patients with ECOG PS > 1 is extremely limited.
CONTRAINDICATIONS
Proleukin® (aldesleukin) is contraindicated in patients with a known history of hypersensitivity to interleukin-2 or any component of the Proleukin formulation.
Proleukin is contraindicated in patients with an abnormal thallium stress test or abnormal pulmonary function tests and those with organ allografts. Retreatment with Proleukin is contraindicated in patients who have experienced the following drug-related toxicities while receiving an earlier course of therapy: sustained ventricular tachycardia (≥ 5 beats), cardiac arrhythmias not controlled or unresponsive to management, chest pain with ECG changes, consistent with angina or myocardial infarction, cardiac tamponade, intubation for > 72 hours, renal failure requiring dialysis > 72 hours, coma or toxic psychosis lasting > 48 hours, repetitive or difficult to control seizures, bowel ischemia/perforation, GI bleeding requiring surgery.
WARNINGS
Because of the severe adverse events which generally accompany Proleukin therapy at the recommended dosages, a thorough clinical evaluation should be performed to identify patients with significant heart, lung, kidney, liver or central nervous system impairment in whom Proleukin is not indicated for use. Patients with normal heart, lung, liver and central nervous system function may experience serious, life-threatening or fatal adverse events.
Should adverse events, requiring dose modification occur, dosage should be withheld rather than reduced.
Proleukin has been associated with exacerbation of preexisting autoimmune disease and inflammatory disorders. In some cases, the onset of new autoimmune diseases, such as vitiligo, may occur. Symptomatic hyperglycemia and/or diabetes mellitus have been reported during Proleukin therapy.
All patients should have thorough evaluation and treatment of CNS metastases and have a negative scan prior to receiving Proleukin therapy. New neurologic signs, symptoms, and anatomic lesions following Proleukin therapy have been reported in patients without evidence of CNS metastases. Neurologic signs and symptoms associated with Proleukin therapy usually improve after discontinuation of Proleukin therapy; however, there are reports of permanent neurologic defects. In patients with known seizure disorders, extreme caution should be exercised as Proleukin may cause seizures.
PRECAUTIONS
Patients should have normal cardiac, pulmonary, hepatic, and CNS function at the start of therapy. Capillary leak syndrome (CLS) begins immediately after Proleukin® (aldesleukin) treatment starts and is marked by increased capillary permeability to protein and fluids and reduced vascular tone.
Proleukin® (aldesleukin) treatment should be withheld for failure to maintain organ perfusion as demonstrated by altered mental status, reduced urine output, a fall in the systolic blood pressure below 90 mm Hg or onset of cardiac arrhythmias.
Recovery from CLS begins soon after cessation of Proleukin therapy. Usually, within a few hours, the blood pressure rises, organ perfusion is restored and reabsorption of extravasated fluid and protein begins.
Kidney and liver function are impaired during Proleukin treatment. Use of concomitant nephrotoxic or hepatotoxic medications may further increase toxicity to the kidney or liver.
Mental status changes including irritability, confusion, or depression which occur while receiving Proleukin may be due to bacteremia or early bacterial sepsis, hypoperfusion, occult CNS malignancy, or direct Proleukin-induced CNS toxicity. Patients should be evaluated for these and other causes of mental status changes. Alterations in mental status due solely to Proleukin therapy may progress for several days before recovery begins. Rarely, patients have sustained permanent neurologic deficits.
Proleukin enhancement of cellular immune function may increase the risk of allograft rejection in transplant patients.
Serious manifestations of eosinophilia involving eosinophilic infiltration of cardiac and pulmonary tissues can occur following Proleukin.
ADVERSE REACTIONS
The rate of drug-related deaths in the 255 metastatic RCC patients who received single-agent Proleukin® (aldesleukin) was 4% (11/255); the rate of drug-related deaths in the 270 metastatic melanoma patients who received single-agent Proleukin was 2% (6/270).
Adverse events are frequent, often serious, and sometimes fatal. The following adverse events (Grades 1-4) were seen in ≥ 30% of 525 patients (255 with metastatic kidney cancer and 270 with metastatic melanoma) treated with Proleukin: low blood pressure (71%), diarrhea (67%), low urine output (63%), chills (52%), vomiting (50%), shortness of breath (43%), rash (42%), increased bilirubin in blood (40%), decreased clotting of blood (37%), nausea (35%), confusion (34%), and decreased kidney function (33%).
Please see the full Prescribing Information, including Boxed Warning, for Proleukin® (aldesleukin) for injection, for intravenous infusion.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
The content contained in this website is not intended to be a substitute for professional medical advice related to any topic discussed. Patients are urged to consult with their treating physicians or other professionals. Never disregard professional, medical, or legal advice or delay seeking such advice because of something you have read on this website.
