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Interleukin-2 (Aldesleukin)

(in-ter-loo-kun)

Trade/other name(s): Proleukin, aldesleukin, IL-2

Why would this drug be used?

Interleukin-2 (IL-2) or aldesleukin is used to treat skin melanomas and kidney cancer. It is also being studied for use against some leukemias, lymphomas, and other cancers, as well as some other diseases.

How does this drug work?

Interleukins are part of a family of proteins called cytokines. Immune system cells in the body normally make small amounts of interleukins as a way to communicate with each other. Different interleukins make parts of the body's immune system more or less active.

Aldesleukin is a man-made version of interleukin-2 (IL-2). It is a form of immunotherapy – it boosts the body's immune system to help fight cancer. IL-2 causes the body to make more of certain immune system cells, prompts immune system cells to be more effective, and causes the cells to make more of some other cytokines.

Before taking this medicine

Tell your doctor…

  • If you are allergic to anything, including medicines, dyes, additives, or foods.
  • If you have any kind of heart disease. In some people this drug may affect the heart's function or rhythm.
  • If you have any lung disease or breathing problem (asthma, emphysema, chronic bronchitis, etc.) This drug may cause lung problems or make existing lung problems worse.
  • If you have an autoimmune disease (where the body's immune system attacks the body's own cells, such as rheumatoid arthritis, lupus, scleroderma, psoriasis, Crohn's disease, myasthenia gravis, diabetes, bullous pemphigoid, etc.). This drug stimulates the immune system, which may make these conditions worse.
  • If you have any other medical conditions such as kidney disease, liver disease (including hepatitis), thyroid problems, bleeding or clotting problems, congestive heart failure, diabetes, gout, or infections. This drug may make some of these conditions worse. You may need closer monitoring of these conditions while being treated, or the drug dose, regimen, or timing may need to be changed.
  • If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. It is not known if this drug might cause problems if either the male or female is taking it at the time of conception or during pregnancy. Check with your doctor about what kinds of birth control can be used with this medicine. This drug should be used during pregnancy only if the potential benefit is thought to justify the potential risk to the fetus.
  • If you are breast-feeding. While no studies have been done, this drug may pass into breast milk and affect the baby. Talk with your doctor about the possible risks of breast-feeding while taking this drug.
  • If you think you might want to have children in the future. It is not known if this drug can affect fertility. Talk with your doctor about the possible risk with this drug and the options that may preserve your ability to have children.
  • About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

This drug is not known to interact directly with other drugs. However, it can cause or worsen a number of conditions, and other drugs may increase this effect. It can also affect the liver and kidneys, which can increase levels of other drugs in the body. Any drugs that affects the kidneys, bone marrow, heart, or liver may have worse effects if you are also taking aldesleukin.

Drugs to control blood pressure, like diuretics and beta blockers, may worsen the low blood pressure with aldesleukin.

Any drugs or supplements that interfere with blood clotting can raise the risk of bleeding during treatment with IL-2. These include:

  • vitamin E
  • non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), and many others
  • warfarin (Coumadin)
  • ticlopidine (Ticlid)
  • clopidogrel (Plavix)

Note that many cold, flu, fever, and headache remedies contain aspirin or ibuprofen. Ask your pharmacist if you aren't sure what's in the medicines you take.

Check with your doctor, nurse, or pharmacist about all of your medicines, herbs, and supplements, and whether alcohol can cause problems with this medicine.

Interactions with foods

No serious interactions with food are known at this time. Check with your doctor, nurse, or pharmacist about whether some foods may be a problem.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

Aldesleukin is usually given by an infusion into a vein (intravenous, or IV) over 15 minutes, every 8 hours. This is done for about 5 days, followed by about 10 days off, and then repeated. These infusions are given in the hospital.

Because there may be serious side effects with high doses, some doctors use a lower-dose regimen. The low dose is given as a daily injection under the skin (subcutaneous, or SubQ), and it can be given in a doctor's office or at home. This drug is sometimes given in other ways, such as a continuous IV infusion over 1 to 3 days, especially if it is part of a treatment plan that includes chemotherapy.

The dose of aldesleukin will depend on your weight, your general health, the type of cancer being treated, and how well you do with the treatment.

Precautions

Side effects with aldesleukin can be serious or life-threatening, especially when the drug is given at high doses. People with serious health conditions (especially heart or lung problems) may not do well with this drug. Your doctor will likely run a number of tests to check the function of your heart, lungs, and other organs before starting treatment.

It's common to have low blood pressure during or soon after the infusion. Tell your nurse if you feel dizzy or faint.

Rarely, this drug may cause fluid to leak out of blood vessels and build up in your lungs, a problem called capillary leak syndrome. Your doctor and nurses will be watching you closely for this. Let your doctor know right away if you feel short of breath, dizzy, lightheaded, or faint. Also, let the doctor know if you have a fast heartbeat, less urine, or if you are unable to keep down fluids and food.

You may have nausea and vomiting on the day you receive this drug or in the first few days afterward. Your doctor may give you medicine before your treatment to help prevent nausea and vomiting. You may also get a prescription for an anti-nausea medicine that you can take at home. It is important to have these medicines on hand and to take them as prescribed by your doctor.

This drug may cause sores in the mouth or on the lips, which often occur within the first few weeks after starting treatment. This can cause mouth pain, bleeding, or even trouble eating. Your doctor or nurse can suggest ways to reduce this, such as changing the way you eat or how you brush your teeth. If needed, your doctor can prescribe medicine to help with the pain.

This drug may cause diarrhea. If left unchecked, this could lead to dehydration and chemical imbalances in the body. Your doctor will likely prescribe medicine to help prevent or control this side effect. It is very important that you take this medicine as prescribed. Make sure you get the medicine right away, so that you will have it at home when you need it. Call your doctor if the medicine doesn't control the diarrhea.

This drug may cause drowsiness and may affect activities such as driving and others that require alertness. Wait until you find out how it affects you before driving or operating other dangerous machinery. Alcohol, sedatives, "nerve pills," or sleeping pills may worsen this effect. Tell your doctor if you are very sleepy or lethargic.

This drug can cause allergic reactions in some people when the drug is given. Mild reactions usually consist of fever and chills. More serious reactions happen rarely, but can be dangerous. Symptoms can include feeling lightheaded or dizzy (due to low blood pressure), fever or chills, hives, nausea, itching, headache, coughing, shortness of breath, or swelling of the face, tongue, or throat. Tell your doctor or nurse right away if you notice any of these symptoms during or after being given the drug. Your doctor or nurse will likely give you medicine to try to prevent an infusion reaction.

Your doctor will likely test your blood throughout your treatment, looking for possible effects of the drug on blood counts or on other body organs (described below). Based on the test results, you may be given medicines to help treat any effects. Your doctor may also need to reduce or delay your next dose of this drug, or even stop it altogether. Keep all your appointments for lab tests and doctor visits.

This drug may affect the function of your liver and kidneys. These organs normally help filter the blood and help the body get rid of certain chemicals. This means other drugs you are taking may stay in the body longer. The drug may need to be stopped or the dose reduced if your blood tests show major changes. If you have kidney disease or liver metastasis or other liver problems before starting treatment, the doctor may need to watch you more closely.

This drug may lower your blood platelet count in the weeks after it is given, which can increase your risk of bleeding. Speak with your doctor before taking any drugs or supplements that might affect your body's ability to stop bleeding, such as aspirin or aspirin-containing medicines, warfarin (Coumadin), or vitamin E. Tell your doctor right away if you have unusual bruising, or bleeding such as nosebleeds, bleeding gums when you brush your teeth, or black, tarry stools.

This drug can lower your white blood cell count, especially in the weeks after the drug is given. This can increase your chance of getting an infection. Be sure to let your doctor or nurse know right away if you have any signs of infection, such as fever (100.5° or higher), chills, pain when passing urine, new onset of cough, or bringing up sputum.

Do not get any immunizations (vaccines), either during or after treatment with this drug, without your doctor's OK. Aldesleukin may affect your immune system. This could make vaccinations ineffective, or could even lead to serious infections if you get a live virus vaccine during or soon after treatment. Try to avoid contact with people who have recently received a live virus vaccine, such as the oral polio vaccine or smallpox vaccine.

Be sure that you tell the doctor you are taking this drug before you get any x-ray with contrast dye that contains iodine. These dyes may be more likely to cause reactions if you have had aldesleukin in the past few weeks.

Rarely, people taking this drug have mental changes like irritability, confusion, or depression. Tell your doctor if you notice this.

Men and women should avoid conceiving a baby while taking this medicine.

Possible side effects

The side effects seen with this drug are more likely to happen and are more likely to be severe if the drug is given as part of a higher-dose rather than a lower-dose regimen.

You will probably not have most of the following side effects, but if you have any talk to your doctor or nurse. They can help you understand the side effects and cope with them.

Common

  • flu-like syndrome (may include fever, chills, tiredness, headache, muscle and joint pain)
  • low blood pressure*
  • nausea/vomiting*
  • diarrhea*
  • feeling weak
  • confusion
  • shortness of breath
  • flushing of the face
  • rash or dry, itchy skin
  • low urine output*
  • abnormal blood tests which suggest that the drug is affecting the liver or kidneys (Your doctor will discuss the importance of this finding, if any.)

Less common

  • feeling dizzy
  • feeling drowsy*
  • sores in the mouth or on the lips*
  • loss of appetite
  • abdominal pain
  • increased heart rate or change in heart rhythm
  • swelling in the face, hands, or feet
  • trouble sleeping
  • trouble concentrating
  • runny nose
  • low platelet count with increased risk of bleeding*
  • low red blood cell count (anemia) with symptoms like tiredness, weakness, shortness of breath
  • low white blood cell count with increased risk of infection*

Rare

  • allergic reaction*
  • cough
  • confusion
  • psychosis (loss of touch with reality)
  • depression
  • seizures
  • coma
  • damage to bowel, ruptured or bleeding bowel
  • serious infection
  • kidney failure
  • heart attack
  • stroke
  • breathing problems
  • death from low blood pressure, capillary leak syndrome, heart problems, or other complications

*See "Precautions" section for more detailed information.

There are some other side effects not listed above that can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 1992.

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.


Last Medical Review: 02/18/2010
Last Revised: 02/18/2010