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Prometheus is dedicated to partnering with oncologists to provide exceptional therapeutic as well as diagnostic options for their patients.
Building on our success in gastroenterology, we have entered the field of oncology with a commitment to developing a portfolio of products and services to assist physicians in diagnosing and treating patients with complex malignant diseases. We focus on the person in every patient, seeking to strengthen our portfolio and our partnership with the oncology community to further personalized care.
Introducing microRNA-based cancer diagnostics
ProOnc TumorSourceDx™
Helps find the source of a tumor for patients with cancer of unknown primary
ProOnc SquamousDx™
Helps differentiate squamous from non-squamous non-small cell lung cancer
ProOnc MesotheliomaDx™
Helps identify malignant mesothelioma
The ProOncDx™ assays unlock the powerful diagnostic potential of microRNAs to help find the source of a tumor, differentiate squamous from non-squamous non-small cell lung cancer, and identify malignant mesothelioma.
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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