Proleukin
From Kidney Cancer Resource
Contents |
Overview
Proleukin also called Aldesleukin is a Novartis product
PROLEUKIN® (aldesleukin) for injection therapy received FDA approval for treatment of metastatic renal cell carcinoma (metastatic kidney cancer) in 1992 and for treatment of metastatic melanoma (a type of skin cancer) in 1998. PROLEUKIN therapy is the first agent approved by the United States Food and Drug Administration (FDA) in over 20 years for patients with metastatic melanoma.
Details
For further details of Proleukin Therapy Click Here
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.
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