Proleukin.  Aldesleukin for Injection




IV Bolus PROLEUKIN® (aldesleukin) for Injection - Information For Healthcare Professionals


IV Bolus PROLEUKIN Facts-at-a-Glance

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The IV Bolus PROLEUKIN Facts-at-a-Glance questions and answers provide a framework for discussing IV Bolus PROLEUKIN therapy with your metastatic melanoma and metastatic renal cell carcinoma patients.

  1. Is your patient a candidate for IV Bolus PROLEUKIN therapy?

    IV Bolus PROLEUKIN therapy has produced the best results in patients with metastatic melanoma or metastatic renal cell carcinoma who are in good overall health. In part, this is because IV Bolus PROLEUKIN therapy is a form of immunotherapy that depends on a healthy immune system to fight cancer. Therefore, patients should have normal cardiovascular, pulmonary function tests and laboratory tests to be considered for treatment.

    It's also important that patients do not have any significant central nervous system conditions or other illnesses that could potentially interfere with IV Bolus PROLEUKIN treatment. Additionally, being healthy helps to insure that any side effects that occur during treatment can be effectively managed by the PROLEUKIN healthcare team.

  2. What are the potential benefits of IV Bolus PROLEUKIN therapy? What are the potential risks?

    For some patients, IV Bolus PROLEUKIN therapy has provided a chance for complete and long-lasting response. However, IV Bolus PROLEUKIN therapy is not successful in every patient with metastatic melanoma or metastatic renal cell carcinoma. Nearly all patients treated with IV Bolus PROLEUKIN therapy experience side effects, some of which may require that therapy be discontinued.

    Proleukin Clinical Response Data

  3. What are the possible side effects associated with IV Bolus PROLEUKIN therapy?

    The most common side effect associated with IV Bolus PROLEUKIN therapy is a condition called capillary leak syndrome (CLS). CLS is associated with swelling that is caused by fluids leaking out of blood vessels into surrounding tissues. If CLS is not treated promptly, it may cause a drop in blood pressure and decreased flow of blood to the organs, and subsequently, changes in heart beat rhythms, severe chest pain, difficulty breathing, heart attack, decreased kidney function, and possibly coma. Other side effects that may occur include sudden low blood pressure, diarrhea, chills, nausea, confusion, scanty urination, and rash. In general, adverse events are frequent, often serious, and sometimes fatal. Please see Prescribing Information for further details.

    It's important to consider that side effects associated with IV Bolus PROLEUKIN therapy vary, and rarely if ever do individual patients experience every potential side effect associated with treatment.

  4. How are side effects managed? Are they reversible?

    Most side effects that occur during IV Bolus PROLEUKIN therapy do so during treatment and improve or disappear entirely within 2 to 3 days of discontinuing therapy. Physicians and nurses who administer IV Bolus PROLEUKIN therapy know the most about the side effects that may occur during therapy and how to effectively and promptly manage them. That's why IV Bolus PROLEUKIN therapy must be administered in a hospital setting.

  5. Can anyone treat patients with IV Bolus PROLEUKIN therapy?

    IV Bolus PROLEUKIN therapy should be administered in a hospital setting under the supervision of a team of physicians and nurses specifically trained in the use of PROLEUKIN®. A regional treatment center can be found through the IV Bolus PROLEUKIN Treatment Center Finder Tool.

  6. Will insurance pay for IV Bolus PROLEUKIN ?

    IV Bolus PROLEUKIN is an FDA-approved treatment for metastatic melanoma and metastatic renal cell carcinoma. Most private insurance will pay for treatment, although the precise amount covered may vary by plan.







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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.

Please see complete prescribing information, including box 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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