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aldesleukin

Generic Name: aldesleukin (AL des LOO kin)
Brand Name: Proleukin

What is aldesleukin?

Aldesleukin is a cancer medication that interferes with tumor growth.

Aldesleukin is used to treat kidney cancer or skin cancer than has spread to other parts of the body.

Aldesleukin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about aldesleukin?

Aldesleukin is a cancer medication used to treat kidney or skin cancer that has spread to other parts of the body.

You should not receive this medication if you have recently had abnormal lung or heart function tests.

Slideshow: Flashback: FDA Drug Approvals 2013

Aldesleukin can cause a serious blood vessel problem. Call your doctor at once if you have mood or behavior changes, confusion, chest pain, trouble breathing, bloody or tarry stools, or little or no urinating.

Also tell your doctor if you feel very drowsy during treatment.

What should I discuss with my healthcare provider before receiving aldesleukin?

You should not receive this medication if you are allergic to aldesleukin or interleukin-2, or if you have:

  • an infection caused by bacteria;

  • if you have received an organ transplant;

  • if you have recently had an abnormal lung function test; or

  • if you have recently had an abnormal exercise test showing decreased blood flow to your heart.

You may not be able to receive aldesleukin if you have had any of these side effects while receiving aldesleukin in the past:

  • irregular heart rhythm;

  • chest pain;

  • a build-up of fluid around your heart;

  • kidney failure;

  • seizures;

  • psychosis (thinking problems, hallucinations, or changes in personality);

  • stomach or intestinal bleeding; or

  • if you needed a breathing tube.

To make sure you aldesleukin is safe for you, tell your doctor if you have:

  • heart disease, angina (chest pain), a heart rhythm disorder, or history of heart attack;

  • lung or breathing problems;

  • kidney disease;

  • liver disease;

  • gallbladder disease;

  • high levels of calcium in your blood (hypercalcemia);

  • a thyroid disorder;

  • diabetes;

  • a seizure disorder;

  • mental illness or neurologic problems; or

  • an autoimmune disorder such as Crohn's disease, scleroderma, arthritis, myasthenia gravis, or a chronic skin disorder.

FDA pregnancy category C. It is not known whether aldesleukin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether aldesleukin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is aldesleukin given?

Aldesleukin is injected into a vein through an IV. A healthcare provider will give you this injection.

Your breathing, blood pressure, oxygen levels, kidney function, and other vital signs will be watched closely while you are receiving aldesleukin. Your blood will also need to be tested daily during treatment, and you may also need chest x-rays.

After 4 weeks off the medication, your doctor will examine you to determine if you need to be treated again with aldesleukin.

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, be sure the doctor knows ahead of time if you have recently received aldesleukin. Some people treated with aldesleukin or similar medication have had unusual allergic reactions to contrast agents used within weeks to several months later.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your aldesleukin injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving aldesleukin?

This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Aldesleukin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe drowsiness, feeling like you might pass out;

  • chest pain, fast or pounding heartbeats;

  • runny or stuffy nose, cough, rapid breathing and heart rate, trouble breathing, swelling and pain in any part of your body;

  • problems with vision, speech, balance, or coordination;

  • mood or behavior changes, confusion, agitation, hallucinations;

  • seizures (convulsions);

  • swelling, rapid weight gain, little or no urinating;

  • black, bloody, or tarry stools;

  • a blistering skin rash;

  • jaundice (yellowing of the skin or eyes); or

  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), nausea and vomiting, mouth sores, unusual weakness.

Common side effects may include:

  • mild stomach pain, diarrhea, loss of appetite.

  • tired feeling; or

  • drowsiness, dizziness, anxiety.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Aldesleukin dosing information

Usual Adult Dose for Renal Cell Carcinoma:

0.037 mg/kg by IV infusion every 8 hours

Infusions may be administered every 8 hours for a maximum of 14 doses. Following 9 days of rest, the schedule may be repeated for another 14 doses, to a maximum of 28 doses per course, as tolerated.


Patients should be evaluated for response approximately 4 weeks after completion of a course of therapy and again immediately prior to the scheduled start of the next treatment course. Additional courses of treatment should be given to patients only if there is some tumor shrinkage following the last course and retreatment is not contraindicated. Each treatment course should be separated by a rest period of at least 7 weeks from the date of hospital discharge.

Usual Adult Dose for Malignant Melanoma:

0.037 mg/kg by IV infusion every 8 hours

Infusions may be administered every 8 hours for a maximum of 14 doses. Following 9 days of rest, the schedule may be repeated for another 14 doses, to a maximum of 28 doses per course, as tolerated.


Patients should be evaluated for response approximately 4 weeks after completion of a course of therapy and again immediately prior to the scheduled start of the next treatment course. Additional courses of treatment should be given to patients only if there is some tumor shrinkage following the last course and retreatment is not contraindicated. Each treatment course should be separated by a rest period of at least 7 weeks from the date of hospital discharge.

What other drugs will affect aldesleukin?

Taking aldesleukin with other drugs that make you sleepy or slow your breathing can increase these effects. Ask your doctor before taking aldesleukin with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Aldesleukin can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Many other drugs may interact with aldesleukin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about aldesleukin.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 5.02. Revision Date: 2013-07-01, 10:57:04 AM.

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