What is PROLEUKIN Therapy and How Does It Work?

PROLEUKIN (aldesleukin) for injection is a recombinant human interleukin-2 (rhIL-2) for treatment in adults with metastatic melanoma and metastatic kidney cancer. PROLEUKIN therapy is a form of immunotherapy that uses the body's natural immune system to fight cancer.

PROLEUKIN has been used for over 10 years in the treatment of metastatic melanoma and over 15 years in the treatment of metastatic kidney cancer (renal cell carcinoma). Studies have demonstrated that PROLEUKIN therapy offers the possibility of a complete and long-lasting response in these diseases.

In Metastatic Renal Cell Carcinoma: Overall response rate (out of 255 patients) = 15% (7% complete, 8% partial). Median duration of complete response (CR*) 6.7+ years (range 7 months - 10+ years).

In Metastatic Melanoma: Overall response rate (out of 270 patients) = 16% (6% complete, 10% partial). Median duration of complete response (CR*) 4.9= years (range 3 months - 10+ years).

What is Interleukin-2?

Interleukin-2 (IL-2) is a protein that occurs naturally in your body and plays an important role in activating your immune system. The immune system protects the body from foreign substances, cells, and tissues by responding to and resisting diseases. PROLEUKIN therapy is a genetically engineered or recombinant version of IL-2. PROLEUKIN therapy possesses the same properties as naturally occurring IL-2 and helps activate the immune system to recognize and eliminate certain kinds of cancer cells.

Your immune system is composed of various types of cells that kill and remove foreign substances from the body. IL-2 activates specialized defense cells called T cells and natural killer (NK) cells to help attack and destroy invading germs or diseases. IL-2 can also stimulate these cells to attack and destroy cancerous tumors.

PROLEUKIN therapy differs from other treatments for metastatic melanoma and metastatic kidney cancer because it's an immunotherapy. Instead of directly inhibiting cancer cells, it works to activate the body's immune system to help kill them.

* A complete response is defined as the disappearance of all signs of cancer in response to treatment.

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The Treatment Center Finder can help you locate an experienced PROLEUKIN treatment center in your area.

PROLEUKIN Product Information Line 1-877-378-4919.

PROLEUKIN (aldesleukin) is indicated for the treatment of adults with metastatic
renal cell carcinoma and metastatic melanoma.

Important Safety Information

Therapy with PROLEUKIN^® (aldesleukin) for injection 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.

IMPORTANT Side Effect Information

In clinical studies, the following life-threatening side effects were seen in >1% of 525 patients (255 with metastatic renal cell cancer and 270 with metastatic melanoma) treated with PROLEUKIN: decreased urine (6%), stopping of all urine (5%), low blood pressure (3%), breathing problems (3%), abnormal blood test (high bilirubin) for how the liver works (2%), coma (2%), diarrhea (2%), too many acid chemicals in the blood (1%), sudden kidney failure (1%), stopping breathing (1%), heart problems (1%), clotting problems (1%), confusion (1%), abnormal blood test (high creatinine) for how the kidney works (1%), shortness of breath (1%), fever (1%), heart attack (1%), infection (1%), severe mental illness (1%), infection in the blood (1%), abnormal blood test (high SGOT) for how the liver works (1%), severe sleepiness (1%), fast heartbeat (2%), low blood platelet count increasing the chance of bleeding (1%), and vomiting (1%).

From the same studies, the following side effects (Grades 1-4, meaning from mild to severe) were seen in >30% of 525 patients (255 with metastatic renal cell cancer and 270 with metastatic melanoma) treated with PROLEUKIN: low blood pressure (71%), diarrhea (67%), decreased urine (63%), chills (52%), vomiting (50%), shortness of breath (43%), rash (42%), abnormal blood test (high bilirubin) for how the liver works (40%), low blood platelet count increasing the chance of bleeding (37%), nausea (35%), confusion (34%), and abnormal blood test (high creatinine) for how the kidney works (33%).

In patients receiving PROLEUKINin these studies (255 with metastatic renal cell carcinoma and 270 with metastatic melanoma), 4% (11/255) of patients with metastatic renal cell cancer and 2% (6/270) of patients with metastatic melanoma died from treatment-related side effects of PROLEUKIN.

Please see complete prescribing information, including boxed warning.

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