Facts About Melanoma

More than 53,000 people in the United States are diagnosed with melanoma every year. It is currently the fastest growing cancer, both in the U.S. and worldwide, especially among young adults between the ages of 20 and 30. While melanoma is very treatable when caught in the early stages, it is the cause of almost 8,000 deaths annually.

Melanoma risk factors: Individuals are at a higher risk of developing cancer if they have certain characteristics called risk factors. A risk factor is a specific trait or behavior that increases the chance of developing a disease. Melanoma risk factors include the following:

Sensitivity to the sun: Melanoma occurs most often in people with fair, freckled skin who sunburn easily and have red or blond hair with blue eyes. People who have had one or more blistering sunburns before the age of sixteen are also at greater risk. Melanoma is not common in people with dark skin. However, dark skinned people are not immune to melanoma and tend to develop the cancer on the palms of the hands, soles of the feet, in their eyes and under the fingernails and toenails.

Personal and family history: People who have had cancer in the past have a greater risk of developing melanoma. People with a family history of melanoma are also more likely to develop the disease. Ten percent of all melanoma patients have family members who also have had melanoma.

Abnormal moles: A dysplastic nevus can increase the risk of melanoma. These moles can appear anywhere on the body. To learn more about abnormal moles, please read Melanoma Symptoms.

Note that people with multiple risk factors for melanoma should undergo a full body examination by their doctor at least once a year to avoid missing any signs on their own. Please contact your physician if you suspect that you might have melanoma.

* For more information on melanoma please refer to the National Cancer Institute and National Institute of Health website at http://www.cancer.gov/cancerinfo/types/melanoma or our Additional Resources and Links Section.

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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 studies, the following life-threatening side effects were seen in >1% of 525 patients (255 with metastatic renal cell cancer and 270 with metastatic melanoma) treated with PROLEUKIN: decreased urine (6%), stopping of all urine (5%), low blood pressure (3%), breathing problems (3%), abnormal blood test (high bilirubin) for how the liver works (2%), coma (2%), diarrhea (2%), too many acid chemicals in the blood (1%), sudden kidney failure (1%), stopping breathing (1%), heart problems (1%), clotting problems (1%), confusion (1%), abnormal blood test (high creatinine) for how the kidney works (1%), shortness of breath (1%), fever (1%), heart attack (1%), infection (1%), severe mental illness (1%), infection in the blood (1%), abnormal blood test (high SGOT) for how the liver works (1%), severe sleepiness (1%), fast heartbeat (2%), low blood platelet count increasing the chance of bleeding (1%), and vomiting (1%).

From the same studies, the following side effects (Grades 1-4, meaning from mild to severe) were seen in >30% of 525 patients (255 with metastatic renal cell cancer and 270 with metastatic melanoma) treated with PROLEUKIN: low blood pressure (71%), diarrhea (67%), decreased urine (63%), chills (52%), vomiting (50%), shortness of breath (43%), rash (42%), abnormal blood test (high bilirubin) for how the liver works (40%), low blood platelet count increasing the chance of bleeding (37%), nausea (35%), confusion (34%), and abnormal blood test (high creatinine) for how the kidney works (33%).

In patients receiving PROLEUKINin these studies (255 with metastatic renal cell carcinoma and 270 with metastatic melanoma), 4% (11/255) of patients with metastatic renal cell cancer and 2% (6/270) of patients with metastatic melanoma died from treatment-related side effects of PROLEUKIN.

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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