Is Your Patient a Candidate for Proleukin®?

Proleukin(aldesleukin) for injection therapy is not appropriate for all patients. Overall health status has been shown to correlate to how a patient will respond to Proleukin therapy.

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

Careful Patient Selection is Crucial

Careful patient selection is mandatory prior to administration of Proleukin therapy. See contraindications and warnings and Precautions and complete prescribing information sections of this website, including the prescribing information regarding patient screening, including recommended cardiac and pulmonary function tests and laboratory tests.**

In the majority of patients receiving Proleukin therapy, most adverse reactions are self-limiting and usually, but not invariably, reverse or improve within 2 to 3 days of discontinuation of therapy. (See Treating with Proleukin for more information. In clinical trials, the following adverse events occurred in greater than 30% of patients receiving Proleukin therapy (in order of frequency): hypotension, diarrhea, oliguria, chills, vomiting, dyspnea, rash, bilirubinemia, thrombocytopenia, nausea, confusion, and creatinine increase.

* Proleukin therapy is indicated for patients 18 years of age or older. Age alone is not an indicator of response to therapy. Early clinical trials evaluating Proleukin therapy included a small number of patients aged 65 and over (experience is limited to 27 patients; 8 with metastatic melanoma and 19 with metastatic renal cell carcinoma), with results demonstrating similar response rates in patients 65 years of age and older compared to those less than 65 years. There was a trend, however, towards an increased incidence of severe urognital toxicities and dyspnea in older patients.

** Proleukin therapy is contraindicated in patients with abnormal thallium stress test or abnormal pulmonary function tests, and in those with organ allografts.

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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