ALDESLEUKIN (Systemic)?

Some commonly used brand names are:

In the U.S.?

• Proleukin

Other commonly used names are interleukin-2 and IL-2.

? Not commercially available in Canada.

Category

• Antineoplastic
• Biologicalresponse modifier

Description

Aldesleukin (al-des-LOO-kin) is a synthetic (man-made) version of a substance calledinterleukin-2. Interleukins are produced naturally by cells in the body tohelp white blood cells work. Aldesleukin is used to treat cancer of the kidneyand skin cancer that has spread to other parts of the body.

Aldesleukin causes some other very serious effects in addition to its helpfuleffects. Some effects can be fatal. For that reason, aldesleukin is givenonly in the hospital. If severe side effects occur, which is common, treatmentin an intensive care unit (ICU) may be necessary. Other effects may not beserious but may cause concern. Before you begin treatment with aldesleukin,you and your doctor should talk about the good this medicine will do as wellas the risks of using it.

Aldesleukin is to be administered only by or under the immediate supervisionof your doctor. It is available in the following dosage form:

Parenteral
• Injection (U.S.)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For aldesleukin, thefollowing should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to aldesleukin.

Pregnancy?Aldesleukin has not been studied in humans or inanimals. However, because this medicine may cause serious side effects, useduring pregnancy is usually not recommended.

Be sure that you have discussed this with your doctor before receivingthis medicine.

Breast-feeding?It is not known whether aldesleukin passes intobreast milk.

Children?There is no specific information comparing use ofaldesleukin in children with use in other age groups.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults. There is no specific information comparinguse of aldesleukin in the elderly with use in other age groups.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other medicine.

Other medical problems?The presence of other medicalproblems may affect the use of aldesleukin. Make sure you tell your doctorif you have any other medical problems, especially:

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)?Risk of severe disease affecting otherparts of the body

• Heart disease or
• Immune system problems or
• Liver disease or
• Lung disease or
• Psoriasis or
• Underactive thyroid?May be worsened by aldesleukin

• Infection?Aldesleukin may decrease your body's ability to fightinfection

• Kidney disease?Effects of aldesleukin may be increased becauseof slower removal from the body

• Mental problems?Aldesleukin may make them worse

• Seizures (history of)?Aldesleukin can cause seizures

Proper Use of This Medicine

Dosing?The dose of aldesleukin will be different for different patients.The dose that is used may depend on a number of things, including what themedicine is being used for, the patient's weight, and whether or not othermedicines are also being taken. Because this medicine can cause very seriousside effects, your doctor will be watching your dose very carefully and maychange it as needed. If you have any questions about the proper dose of aldesleukin,ask your doctor.

Precautions While Using This Medicine

Aldesleukincan temporarily affect the white blood cells in your blood, increasing thechance of getting an infection. It can also lower the number of platelets,which are necessary for proper blood clotting. If this occurs, there are certainprecautions you can take, especially when your blood count is low, to reducethe risk of infection or bleeding:

• If you can, avoid people with infections. Checkwith your doctor immediately if you think you are getting an infectionor if you get a fever or chills, cough or hoarseness, lower back or side pain,or painful or difficult urination.
• Check with your doctor immediately ifyou notice any unusual bleeding or bruising; black, tarry stools; blood inurine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick.Your medical doctor, dentist, or nurse may recommend other ways to clean yourteeth and gums. Check with your medical doctor before having any dental workdone.
• Do not touch your eyes or the inside of your nose unless you havejust washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects suchas a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injurycould occur.

Side Effects of This Medicine

Along with its needed effects,a medicine may cause some unwanted effects. Some side effects will have signsor symptoms that you can see or feel. Your doctor may watch for others bydoing certain tests.

Check with your doctoror nurse immediately if any of the following side effects occur:

More common

Fever or chills; shortness of breath

Less common

Black, tarry stools; blisters on skin; blood in urine; bloodyvomit; chest pain; coughor hoarseness; lower back or side pain; painful or difficult urination; pinpointred spots on skin; stomach pain (severe); unusual bleeding or bruising

Check with your health careprofessional as soon as possible if any of the following side effects occur:

More common

Agitation; confusion; diarrhea; dizziness; drowsiness; mental depression; nauseaand vomiting; sores in mouth and on lips; tingling of hands or feet; unusual decreasein urination; unusual tiredness; weight gain of 5 to 10 pounds or more

Less common

Bloating and stomach pain; blurred ordouble vision; faintness; fast or irregular heartbeat; loss of taste; rapid breathing; redness, swelling,and soreness of tongue; trouble in speaking; yellow eyes and skin

Rare

Changes in menstrual periods; clumsiness; coldness; convulsions(seizures); listlessness; muscle aches; pain or redness at site of injection; sudden inability to move; swelling in the front of the neck; swelling of feetor lower legs; weakness

This medicine may also causethe following side effects that your doctor will watch for:

More common

Anemia; heart problems; kidney problems; liver problems; low blood pressure; low platelet countsin blood; low white blood cell counts; other blood problems; underactive thyroid

Other side effects may occur that usually do not need medical attention.These side effects may go away during treatment as your body adjusts to themedicine. Also, your health care professional may be able to tell you aboutways to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects continue or are bothersomeor if you have any questions about them:

More common

Dry skin; loss of appetite; skin rash or redness with burning or itching, followed by peeling; unusual feeling of discomfort or illness

Less common

Constipation; headache; joint pain; muscle pain

Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.