Proleukin® FAQs

The Proleukin FAQs questions and answers provide a framework for discussing Proleukin therapy with your metastatic melanoma and metastatic renal cell carcinoma patients.

1. Is your patient a candidate for Proleukin therapy?

Proleukin therapy has produced the best results in patients with metastatic melanoma or metastatic renal cell carcinoma who are in good overall health. In part, this is because Proleukin therapy is a form of immunotherapy that depends on a healthy immune system to fight cancer.

If your patients with metastatic renal cell carcinoma and metastatic melanoma have the following characteristics, consider giving them the chance for a complete and durable response with Proleukin:

  • ECOG performance status (PS) 0/1 or an equivalent Karnofsky score
  • Normal CNS function and absence of CNS metastases
  • Normal cardiac function as measured by an electrocardiogram and thallium stress test
  • Normal pulmonary and hepatic function
  • No organ allografts

2. What are the potential benefits of Proleukin therapy?

For some patients, Proleukin therapy has provided a chance for complete and long-lasting response. However, Proleukin therapy is not successful in every patient with metastatic melanoma or metastatic renal cell carcinoma. Nearly all patients treated with Proleukin therapy experience side effects, some of which may require that therapy be discontinued.

Clinical Response Metastatic Melanoma

Clinical Response Carcinoma

3. What are the possible side effects associated with Proleukin therapy?

Proleukin administration has been associated with capillary leak syndrome (CLS). CLS is associated with swelling that is caused by fluids leaking out of blood vessels into surrounding tissues. If CLS is not treated promptly, it may cause a drop in blood pressure and decreased flow of blood to the organs, and subsequently, changes in heart beat rhythms, severe chest pain, difficulty breathing, heart attack, decreased kidney function, and possibly coma. Other side effects that may occur include sudden low blood pressure, diarrhea, chills, nausea, confusion, scanty urination, and rash. In general, adverse events are frequent, often serious, and sometimes fatal.

Please see full Prescribing Information, including boxed warning for further details.

Side effects associated with Proleukin therapy vary, and rarely if ever do individual patients experience every potential side effect associated with treatment.

4. How are side effects managed? Are they reversible?

Most side effects that occur during Proleukin therapy do so during treatment and may improve or disappear entirely within 2 to 3 days of discontinuing therapy. Proleukin therapy must be administered in a hospital setting where physicians and nurses are experienced in administering this therapy.

5. Can anyone treat patients with Proleukin therapy?

Proleukin therapy should be administered in a hospital setting at experienced treatment centers. A regional treatment center can be found through the Proleukin Treatment Center Finder Tool.

6. Will insurance pay for Proleukin?

Proleukin is an FDA-approved treatment for metastatic melanoma and metastatic renal cell carcinoma. Most private insurance will pay for treatment, although the precise amount covered may vary by plan.


Proleukin® (aldesleukin) is indicated for the treatment of adults with metastatic renal cell carcinoma or metastatic melanoma.

IMPORTANT Safety Information

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.

Proleukin® (aldesleukin) Side Effects

The following adverse events (Grades 1-4) were seen in ≥30% of 525 patients (255 with metastatic renal cell cancer and 270 with metastatic melanoma) treated with Proleukin®: hypotension (71%), diarrhea (67%), oliguria (63%), chills (52%), vomiting (50%), dyspnea (43%), rash (42%), bilirubinemia (40%), thrombocytopenia (37%), nausea (35%), confusion (34%), and creatinine increase (33%).

Because of the severe adverse events which generally accompany Proleukin therapy at the recommended dosages, thorough clinical evaluation should be performed to identify patients with significant cardiac, pulmonary, renal, hepatic, or CNS impairment in whom Proleukin is contraindicated. Patients with normal cardiovascular, pulmonary, hepatic, and CNS function may experience serious, life threatening or fatal adverse events. Adverse events are frequent, often serious, and sometimes fatal.

In patients receiving single-agent Proleukin (255 with metastatic renal cell carcinoma and 270 with metastatic melanoma), the rate of drug related deaths was 4% (11/255) in mRCC patients and 2% (6/270) in mM patients.

Survival benefit has not been demonstrated.

Please see complete prescribing information, including BOXED WARNING.

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.

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