aldesleukin

Generic Name: aldesleukin (AL des LOO kin)Brand Names: 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 other purposes not listed in this medication guide.

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

You should not receive this medication if you are allergic to aldesleukin or interleukin-2, or if you have a bacterial infection, if you have received an organ transplant, or if you have recently had abnormal lung or heart function tests. You may not be able to receive aldesleukin if prior treatment with this medication caused chest pain, irregular heart rhythm, a build-up of fluid around your heart, kidney failure, seizures, psychosis, stomach or intestinal bleeding, or if you needed a breathing tube.

Before you receive aldesleukin, tell your doctor if you have a heart disorder or history of heart attack, breathing problems, kidney or liver disease, gallbladder disease, high levels of calcium in your blood, a thyroid disorder, diabetes, seizures, mental illness, neurologic problems, or an autoimmune disorder (arthritis, Crohn's disease, scleroderma, myasthenia gravis, or skin disorder).

There are many other drugs that can interact with aldesleukin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

If you need to have any type of x-ray or other scan using a contrast agent (a dye that is used to help blood vessels, organs, and other non-bony tissues appear more clearly on the x-ray or scan), 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 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.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely receive aldesleukin:

• 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 is harmful to an unborn baby. Before receiving this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether aldesleukin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is aldesleukin given?

Aldesleukin is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take at least 15 minutes to complete.

Aldesleukin is usually given every 8 hours for up to 5 days, followed by a 9-day rest period and then repeated.

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 other scan using a contrast agent (a dye that is used to help blood vessels, organs, and other non-bony tissues appear more clearly on the x-ray or scan), 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 if you think you have used too much of this medicine.

Overdose symptoms may include confusion, hallucinations, fast or pounding heartbeats, chest pain, trouble walking or breathing, painful swelling in any part of your body, problems with vision or speech, urinating less than usual , or seizure (convulsions).

What should I avoid while receiving aldesleukin?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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 a serious side effect such as:

• 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;

• black, bloody, or tarry stools;

• urinating less than usual or not at all;

• 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.

Less serious side effects may include:

• mild stomach pain;

• tired feeling;

• drowsiness, dizziness, anxiety; or

• diarrhea, loss of appetite.

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.

Aldesleukin Dosing Information

Usual Adult Dose for Renal Cell Carcinoma:

0.037 mg/kg by IV infusion every 8 hoursInfusions 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 hoursInfusions 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?

Before receiving aldesleukin, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, anxiety, or nausea and vomiting). They can add to sleepiness caused by aldesleukin.

Aldesleukin can be harmful to the kidneys, liver, heart, or bone marrow. These effects are increased when aldesleukin is used together with other medicines that can cause similar harmful effects. Tell your doctor about all other medications you are using, especially:

• an antibiotic taken by mouth or given in an IV;

• an antidepressant;

• antifungal medication;

• anti-malaria medications;

• antiviral medications, or medicines to treat HIV or AIDS;

• birth control pills or hormone replacement therapy;

• cholesterol-lowering medications;

• digoxin and other heart rhythm medication;

• heart or blood pressure medications;

• medicines to treat a bowel disorder;

• medicine to treat a psychiatric disorder;

• other cancer medications;

• pain or arthritis medicines (including aspirin, acetaminophen, gold compounds, or a non-steroidal anti-inflammatory drug [NSAID]);

• seizure medications;

• a steroid; or

• tuberculosis medications.

This list is not complete and there may be other drugs that can interact with aldesleukin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about aldesleukin.

• 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 1996-2006 Cerner Multum, Inc. Version: 2.04. Revision Date: 10/13/2009 10:20:32 AM.