Is Your Patient a Candidate for IV Bolus PROLEUKIN?
IV Bolus 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 IV Bolus PROLEUKIN therapy.
Eligibility requirements for IV Bolus PROLEUKIN therapy include:
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ECOG performance status 0-1 |
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Age over 18 years* |
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Good overall health |
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Normal heart, lungs, kidney, liver, and central nervous system function |
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No brain metastases |
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No evidence of infection |
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No organ allografts |
Careful Patient Selection is Crucial
Careful patient selection is mandatory prior to administration of IV Bolus PROLEUKIN therapy. See contraindications and warnings 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 IV Bolus 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 IV Bolus PROLEUKIN therapy (in order of frequency): hypotension, diarrhea, oliguria, chills, vomiting, dyspnea, rash, bilirubinemia, thrombocytopenia, nausea, confusion, and creatinine increase.
*IV Bolus 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 IV Bolus 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.
**IV Bolus PROLEUKIN therapy is contraindicated in patients with abnormal thallium stress test or abnormal pulmonary function tests, and in those with organ allografts.
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