PROLEUKIN in Metastatic Renal Cell Carcinoma

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Pooled data from 7 clinical studies carried out at 21 participating institutions have demonstrated that in some patients with metastatic renal cell carcinoma, PROLEUKIN therapy produced a complete and durable response. Similar to results observed among metastatic melanoma patients, the median duration for complete response was not reached during trial, and median duration for partial response was 19 months, with many clinical responses ongoing.

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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 trials, the following life-threatening (Grade 4) adverse events were seen in > 1 % of 525 patients (255 with metastatic renal cell cancer and 270 with metastatic melanoma) treated with PROLEUKIN: oliguria (6%), anuria (5%), hypotension (3%), respiratory disorder (3%), bilirubinemia (2%), coma (2%), diarrhea (2%), acidosis (1%), acute kidney failure (1 %), apnea (1 %), cardiovascular disorder (1%), coagulation disorders (1%), confusion (1%), creatinine increase (1%), dyspnea (1%), fever (1%), heart arrest (1%), infection (1%), myocardial infarct (1%), psychosis (1%), sepsis (1%), SGOT increase (1%), stupor (1%), supraventricular tachycardia (1%), thrombocytopenia (1%), ventricular tachycardia (1%), and vomiting (1%).

From the same trials, 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%).

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.

Please see complete prescribing information, including boxed warning.

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