Aldesleukin

What is Aldesleukin?

• Aldesleukin (Proleukin) a human recombinant interleukin-2 product, is a highly purified protein used in immune therapy of renal cell cancer and malignant melanoma.

What are the uses of this medicine?

• Aldesleukin (Proleukin) is indicated for the treatment of adults with metastatic renal cell carcinoma (metastatic RCC).
• Proleukin is indicated for the treatment of adults with metastatic melanoma.

How does this medicine work?

• Aldesleukin (al" des loo' kin) is recombinant form of interleukin-2 (IL-2), a human cytokine produced by macrophages and lymphocytes that induces the proliferation and maturation of T cells.
• Also known as T cell growth factor, interleukin-2 is a critical cytokine in the adaptive immune process and interacts with specific T cell receptors to activate intracytoplasmic pathways that lead to proliferation and differentiation of immature T lymphoblasts into mature and reactive T cells that play an important role in immune responses to foreign proteins, viruses and bacteria and tumor cells.
• A recombinant form of interleukin-2 has been developed and shown to be an immune modulator and to have antitumor activity against several malignancies, but most convincingly renal cell cancer and malignant melanoma.
• Proleukin is a form of interleukin-2 that is made in the laboratory.
• Proleukin increases the activity and growth of T lymphocytes and B lymphocytes (types of white blood cells).
• This may help the immune system kill cancer cells.
• Proleukin is a type of biological response modifier.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• a known history of hypersensitivity to interleukin-2 or any component of the Proleukin formulation.
• an abnormal thallium stress test or abnormal pulmonary function tests and those with organ allografts.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Proleukin.

Is this medicine FDA approved?

• Aldesleukin was approved for use in the United States for malignant melanoma in 1992 and indications were subsequently broadened and now include metastatic renal cell carcinoma and metastatic malignant melanoma.

How should this medicine be used?

Recommended dosage:

• 600,000 International Units/kg (0.037 mg/kg) dose administered every 8 hours by a 15-minute intravenous infusion for a maximum of 14 doses. Following 9 days of rest, the schedule is repeated for another 14 doses, for a maximum of 28 doses per course, as tolerated.

Administration:

• The recommended Proleukin® (aldesleukin) treatment regimen is administered by a 15-minute intravenous infusion every 8 hours.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection, for intravenous infusion

This medicine is available in fallowing brand namesː

• Proleukin

What side effects can this medication cause?

The most common side effects of this medicine include:

• fatigue, fever, chills, nausea, diarrhea, and capillary leak syndrome which can cause peripheral edema, hypotension, renal insufficiency and pulmonary edema.
• Less common, but potentially severe adverse reactions include shock, anaphylaxis, severe infections, autoimmune conditions and neurologic complications including sleepiness, stupor and coma.

What special precautions should I follow?

• When given in high doses, interleukin-2 regularly causes mild-to-moderate elevations in serum enzymes and bilirubin, but it rarely results in clinically significant acute liver injury.
• 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.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Management of overdosage:

• Symptoms which persist after cessation of Proleukin should be monitored and treated supportively.
• Life-threatening toxicities may be ameliorated by the intravenous administration of dexamethasone, which may also result in loss of the therapeutic effects of Proleukin.

Can this medicine be used in pregnancy?

• There are no adequate well-controlled studies of Proleukin in pregnant women.
• Proleukin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Safety and effectiveness in children under 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• aldesleukin

Inactive ingredients:

• MANNITOL
• SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
• SODIUM LAURYL SULFATE
• SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
• WATER

Who manufactures and distributes this medicine?

Manufactured by:

• Prometheus Laboratories Inc.
• San Diego, CA

At:

• Boehringer Ingelheim Pharma
• Biberach/Riss, Germany

• PROLEUKIN is a registered trademark of Novartis Vaccines and Diagnostics, Inc.

What should I know about storage and disposal of this medication?

• Store vials of lyophilized Proleukin in a refrigerator at 2° to 8°C (36° to 46°F).
• PROTECT FROM LIGHT.
• Store in carton until time of use.
• Reconstituted or diluted Proleukin is stable for up to 48 hours at refrigerated and room temperatures, 2° to 25°C (36° to 77°F).
• However, since this product contains no preservative, the reconstituted and diluted solutions should be stored in the refrigerator.
• Do not use beyond the expiration date printed on the vial.

• Dailymed label info on Aldesleukin
• FDA Aldesleukin

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