1 What is Proleukin?

Brand: Proleukin

Generic: Aldesleukin

Proleukin injection is an anti-cancer medication used to treat metastatic kidney cancer (cancer that has already spread to the body) and metastatic skin cancer.

Proleukin is a man-made version of a substance called interleukin-2. Interleukins are produced naturally by cells in the body to help white blood cells work.

Proleukin causes very serious side effects in addition to its helpful effects. Some effects can be fatal. For this reason, aldesleukin injection is only given in the hospital. If severe side effects occur, which is common, treatment in an intensive care unit (ICU) may be necessary.

Other effects may not be serious but may cause concern. Before you begin treatment with this medication, talk with your doctor about the benefits of this medication as well as the risks.

This medication is to be administered only by or under the direct supervision of your doctor. This product is available in the following forms:

  • Powder for solution

2 What to Know Before Using

Before using Proleukin, you must know all about the risks and complications associated with it. This is a decision that you and your doctor will make together. 

For this medication, there are many things that need to be considered:


Inform your doctor if you have ever had an allergic reaction to doxorubicin or to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.


No appropriate studies have been performed on the relationship of age to the effects of this medication in children. Safety and efficacy have not been established.


Up-to-date studies have not shown any problems specific to the elderly that would limit the use of this medication in the elderly population. However, elderly patients are more likely to have breathing difficulties and age-related kidney problems, which may require caution and an adjustment in the dose for elderly patients receiving this medication.


This medication is listed as Pregnancy Category C. This means that animal studies have shown an adverse effect and no studies have been performed on pregnant women OR there are no adequate studies on pregnant animals and pregnant women.


There are no up-to-date studies in women for determining infant risk when using this medication while breastfeeding. Weigh the potential risks with the benefits before taking this medication while breastfeeding.

Drug Interactions

Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions. When taking this medication, it is important that you inform your doctor if you are taking any of the medications listed below. The following interactions were selected on the basis of potential significance and are not all-inclusive.

Using this medication with any of the following is not recommended. Your doctor may decide not to treat you with this medication, or change some of the other medications you take:

  • Rotavirus vaccine, live

Using this medication with any of the following medication is not recommended, but may be unavoidable in some cases.

Your doctor may make the decision not to treat you with this medication or change some of the other medications you take:

Using this medication with any of the following medications may increase your risk of side effects. However, using both medications may be the best treatment for you.

If both medications are prescribed together, your doctor may change the dose or how often you take one or both medications:

  • Cisplatin
  • Dacarbazine
  • Interferon Alfa
  • Tamoxifen

Other Interactions

Certain medications should not be used while eating, or while eating certain foods in case of negative interactions. Using alcohol or tobacco with certain medications may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.

Other Medical Problems

Pre-existing medical problems may affect the use of this medication.

Be sure to tell your doctor if you have any other medical problems, especially:

  • Abnormal pulmonary function test
  • Abnormal thallium stress test
  • Arrhythmia (heart rhythm problem)
  • Chest pain consistent with angina or heart attack (with ECG changes)
  • Heart disease
  • Intubation for more than 72 hours
  • Kidney failure
  • Mental illness
  • Organ allograft
  • Seizures, repetitive or uncontrolled
  • Stomach or bowel problems (e.g., bleeding that requires surgery, blockage, perforation)
  • Ventricular tachycardia, sustained—Should not be given to patients with these conditions.
  • Allergic reaction
  • Autoimmune disease
  • Cerebral vasculitis
  • Cholecystitis (inflammation or swelling of the gallbladder)
  • Crohn's disease
  • Diabetes
  • Eye problems (e.g. oculo-bulbar myasthenia gravis)
  • Hypercalcemia (high calcium in the blood)
  • Hypotension (low blood pressure)
  • Kidney disease
  • Liver disease
  • Thyroid disease—Use with caution. May make these conditions worse.
  • Infection—May decreases your body's ability to fight infection.

3 Proper Usage

To use Proleukin properly, you must follow all instructions given by your doctor. Medications used to treat cancer are very strong and can cause many side effects. Before taking this medication, be sure you understand all the risks and benefits.

You will receive this medication while in the hospital or cancer treatment center. A nurse or other trained health professional will give you this medication. This medication is given through a needle placed in one of your veins (intravenous).

4 Precautions to Take

Before using Proleukin, there are some precautions you must take. It is very important that your doctor check you closely to make sure the medication is working properly. Blood and urine tests, certain laboratory tests and chest x-rays will be needed before receiving this medication and to check for unwanted effects.

Capillary leak syndrome (CLS) may occur immediately after receiving this medication. Your doctor will monitor your blood pressure and heart rate frequently to avoid the lowering of blood pressure.

Tell your doctor or nurse immediately if you have:

  • unusual drowsiness
  • dullness
  • sleepiness
  • fatigue
  • weakness
  • sluggishness
  • unusual changes in mood or behaviour such as irritability
  • confusion or depression

after receiving this medication. These could be signs of a serious medical problem.

Aldesleukin can temporarily affect the white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take to reduce the risk of infection or bleeding.

  • Take steps to avoid people with infections. Inform your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Inform your doctor immediately if you notice any unusual bleeding or bruising, black or tarry stool, blood in the urine or stool or red spots on your skin.
  • Be careful when using a toothbrush, dental floss or toothpick. Your doctor, dentist or nurse may recommend other ways to clean your teeth and gums. Ask your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when using sharp objects such as a shaving razor or fingernail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

Do not take other prescription or over the counter medications unless you have asked your doctor.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Proleukin. Although not all of these side-effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if you experience any of the following side-effects:

More common:

Less common:


  • Changes in menstrual periods
  • Clumsiness
  • Coldness
  • Convulsions (seizures)
  • Listlessness
  • Muscle aches
  • Pain or redness at injection site
  • Sudden inability to move
  • Swelling in the front of the neck
  • Swelling of the feet or lower legs
  • Weakness

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment. Ask your doctor about ways to prevent or reduce some of these side effects.

Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

  • Dry skin
  • Loss of appetite
  • Skin rash or redness with burning or itching, followed by peeling
  • Unusual feeling of discomfort or illness (malaise)

Less common:

Some patients may experience other side effects that are not listed. Check with your doctor if you notice any other side effects.

Ask your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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