Generic name: Aldesleukin
Trade name: Proleukin ®
Other names: IL-2

Proleukin is the trade name for the generic drug name Aldesleukin. IL-2 and Interleukin-2 are other names for Aldesleukin. In some cases, health care professionals may use the trade name Proleukin or other names IL-2 and Interleukin-2 when referring to the generic drug name Aldesleukin.

Drug type: Interleukin-2 is a "biologic response modifier." Interleukin-2 is classified as a "cytokine." (For more detail, see "How this drug works" section below).

What Interleukin-2 Is Used For:

• Cancers treated with Interleukin-2 include renal cell (kidney) and melanoma, a skin cancer.

How Interleukin-2 Is Given:

Interleukin-2 has been approved for cancer treatment with a high-dose regimen, but it may also be administered in a low-dose form.  The high-dose regimen involves giving the drug intravenously (into a vein) every eight hours, as tolerated, for up to 15 doses.  There are significant side effects with this regimen (though they are reversible once treatment is stopped).  Because of the severity of these side effects, patients are hospitalized and sometimes need intensive care unit support while the drug is being given.

In order to lessen these side effects, an alternate, low-dose regimen was developed.   "Low-dose interleukin-2" is administered on an outpatient basis.  Low-dose interleukin-2 is usually given as a shot under the skin (subcutaneous injection, SubQ).  In some situations, patients may be able to give themselves these injections at home.

Side Effects:

Important things to remember about the side effects of Interleukin-2: 

• Most people do not experience all of the side effects listed.
• Side effects are often predictable in terms of their onset, duration and severity.
• Side effects are almost always reversible and will go away after treatment is complete.
• There are many options to help minimize or prevent side effects.
• There is no relationship between the presence or severity of side effects and the effectiveness of the medication
• Interleukin-2's side effects and their severity depend on how much of the drug is given.  In other words, high doses may produce more severe side effects.  In some cases, this could necessitate hospitalization and/or intensive care unit support.

The following are common (occurring in greater than 30%) side effects for patients taking Interleukin-2:

• Fever and chills or flu-like symptoms.  The severity decreases over time, particularly in low-dose regimens.
• Generalized flushing (redness) of the face and body, or skin rash.  (All patients on high-dose therapy will experience this effect.) (see skin reactions).
• Nausea or vomiting
• Lowered blood pressure
• Diarrhea
• Low blood counts.  Your white and red blood cells and platelets may temporarily decrease in number.  This can put you at increased risk for infection, anemia and/or bleeding.
• Changes in mental status, such as confusion, drowsiness or memory loss.
• Fast heart beats (tachycardia) (see heart problems).
• Lowered urine output.
• Changes in liver function (see liver problems).
• Generalized aches and pains (see pain).
• Swelling of the face, ankles or legs (edema or water retention).

The following are less common (occurring in 10 to 29%) side effects for patients taking Interleukin-2:

• Respiratory congestion or breathing difficulty (see lung problems).
• Itching
• Low blood counts (low white blood cells)
• Mouth sores
• Poor appetite
• Fatigue
• Weight gain or loss
• Infection
• Irregular heart beats (see heart problems).
• Dizziness.
• Dry or peeling skin (see skin reactions)
• Injection site reactions (with subcutaneous, or under the skin, injections)

A serious, but very uncommon side effect of Interleukin-2 in high doses is "capillary leak syndrome" or "vascular leak syndrome."  Capillary leak syndrome is a potentially serious disease in which fluids within the vascular system (veins and capillaries) leaks into the tissue outside the bloodstream.  This results in low blood pressure and poor blood flow to the internal organs.  Capillary leak syndrome is characterized by the presence of 2 or more of the following 3 symptoms; low blood pressure, swelling, and low levels of protein in the blood.  Your doctor will monitor these things carefully while you are taking Interleukin-2.   You should notify your doctor immediately if you notice dizziness (especially when changing position), sudden swelling or rapid weight gain, little or no urine output (for 8-12 hours), shortness of breath, difficulty breathing, irregular heart beats, or chest pain.

Not all side effects are listed above, some that are rare (occurring in less than 10% of patients) are not listed here.  However, you should always inform your health care provider if you experience any unusual symptoms.

When to contact your doctor or health care provider:

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

• Wheezing or difficulty breathing
• Dizziness (especially when changing position), sudden swelling or rapid weight gain, little or no urine output (for 8-12 hours), shortness of breath, difficulty breathing, irregular heart beats or chest pain.

The following symptoms require medical attention, but are not an emergency.  Contact your health care provider within 24 hours of noticing any of the following:

• Anxiety, changes in thinking or mood, confusion, difficulty concentrating or trouble sleeping.
• Diarrhea (more than 4 to 6 episodes in a 24-hour period).
• Nausea that interferes with eating and is not relieved by medications prescribed by your doctor.
• Vomiting (more than 4 to 5 episodes within a 24-hour period).
• Sustained fever (fever lasting/occurring beyond the expected timeframe for dose and schedule).
• Unusual bleeding or bruising.
• Black or tarry stools, or blood in your stools or urine.
• Extreme fatigue (unable to perform self-care activities).

In addition, call your health care provider if any side effects become continuous, serious or your condition worsens.

Precautions:

• Before starting aldesleuken treatment, make sure you tell your doctor about any other medications you are taking (including over-the-counter medications, vitamins or herbal remedies).  Do not take aspirin, or products containing aspirin, unless your doctor permits this. 
• For up to several months after Interleukin-2 treatment has ended, patients may have a reaction to the iodine-containing contrast material used for CT scans.  These reactions may include fever, chills, nausea and vomiting, itching, rash, diarrhea or swelling.
• Do not receive any kind of vaccination without your doctor's approval while taking Interleukin-2.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment.  Pregnancy category C (use in pregnancy only when benefit to mother outweighs risk to fetus).
• For both men and women: Do not conceive a child (get pregnant) while taking aldesleuken. Barrier methods of contraception, such as condoms, are recommended. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
• Do not breast-feed while taking this medication.

Self-Care Tips:

• For flu-like symptoms, keep warm with blankets and drink plenty of liquids.  There are medications that can help reduce the discomfort caused by chills.
• Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
• To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times a day with 1/2 - 1 teaspoon of baking soda or salt mixed with 8 ounces of water.
• Patients receiving injections under the skin may develop pain and hard bumps at the injection sites.  These reactions are normal.  Pain will go away within minutes, although the bumps may remain for a few months after therapy. Changing the sites of the injections, and using warm or cold compresses are helpful.
• To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
• Avoid sun exposure. Wear SPF 15 (or higher) sunblock and protective clothing.
• In general, drinking alcoholic beverages should be minimized or avoided.  You should discuss this with your doctor.
• Wash your hands often.
• You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your healthcare provider.
• Maintain good nutrition.
• If you experience symptoms or side effects, be sure to discuss them with your health care team.  They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

Before starting treatment with Interleukin-2, your doctor will perform a physical exam.  Blood tests and often-other types of tests, as decided by your doctor, will be used to evaluate the function of your major organs (heart, lungs, kidneys and liver).  Throughout your therapy, your doctor will see you regularly to assess any changes in your blood pressure, weight and level of fatigue, and to discuss side effects.  The doctor will order blood tests and other tests as needed to monitor side effects and check your response to therapy.

How Interleukin-2 Works:

Interleukin-2 is classified as a "biologic response modifier (BRM)" or "biologic therapy."  BRMs modify the body's response to cancer cells. Interleukin-2 is part of a family of proteins called cytokines.  Cytokines act primarily by communicating between the various cells of the body's immune system.

Interleukin-2 helps increase production of several different components of the immune system found in the blood, including T lymphocytes and natural killer cells.  It also may improve the function of other immune system cells, such as lymphokine-activated killer cells and tumor-infiltrating lymphocytes.  This helps the body fight cancer.

Interleukin-2 is a synthetic form of interleukin-2, a protein that the body produces naturally. Interleukin-2 was discovered more than 20 years ago.  The U.S. Food and Drug Administration approved it in its synthetic form for treatment against cancer in 1992.

Note:  We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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