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.

You should not be treated with aldesleukin if you have recently had abnormal lung or heart function tests.

Tell your doctor right away if you have signs of a serious side effect called capillary leak syndrome: stuffy or runny nose followed by tiredness or dizziness, thirst, decreased urination, trouble breathing, and sudden swelling or weight gain.

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

Aldesleukin is given as an infusion into a vein. A healthcare provider will give you this injection.

Your breathing, blood pressure, oxygen levels, kidney function, and other vital signs will be watched closely.

You will need daily blood tests, and you may also need chest x-rays.

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

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

Usual Adult Dose for Renal Cell Carcinoma:

0.037 mg/kg (600,000 IU/kg) every 8 hours via a 15-minute IV infusion for a maximum of 14 doses; the schedule is repeated for another 14 doses after 9 days of rest.

Maximum Dose: 28 doses per course, as tolerated

Therapy Duration: During the first therapy course, metastatic RCC patients received a median of 20 doses and metastatic melanoma patients received a median of 18 doses.

Comments:
-Each treatment course consists of two 5-day treatment cycles separated by a rest period.
-Patient selection should include assessment of ECOG PS (Eastern Cooperative Oncology Group performance status).

Uses:
-Metastatic melanoma
-Metastatic renal cell carcinoma (metastatic RCC)

Usual Adult Dose for Melanoma -- Metastatic:

0.037 mg/kg (600,000 IU/kg) every 8 hours via a 15-minute IV infusion for a maximum of 14 doses; the schedule is repeated for another 14 doses after 9 days of rest.

Maximum Dose: 28 doses per course, as tolerated

Therapy Duration: During the first therapy course, metastatic RCC patients received a median of 20 doses and metastatic melanoma patients received a median of 18 doses.

Comments:
-Each treatment course consists of two 5-day treatment cycles separated by a rest period.
-Patient selection should include assessment of ECOG PS (Eastern Cooperative Oncology Group performance status).

Uses:
-Metastatic melanoma
-Metastatic renal cell carcinoma (metastatic RCC)

You should not be treated with aldesleukin if you are allergic to aldesleukin or interleukin-2, or if:

• you have an active infection caused by bacteria;

• you have received an organ transplant;

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

• 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've 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;

• gallbladder disease;

• seizures;

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

• stomach or intestinal bleeding; or

• if you needed a breathing tube.

Tell your doctor if you have ever had:

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

• lung or breathing problems;

• kidney disease;

• liver 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.

Tell your doctor if you are pregnant or breastfeeding.

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

Since aldesleukin is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Unless your doctor tells you otherwise, continue your normal diet.

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

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

Tell your doctor right away if you have signs of a serious side effect called capillary leak syndrome: stuffy or runny nose followed by tiredness or dizziness, thirst, decreased urination, trouble breathing, and sudden swelling or weight gain.

Aldesleukin may cause serious side effects. Call your doctor at once if you have:

• severe drowsiness, feeling like you might pass out;

• chest pain, fast or pounding heartbeats;

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

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

• seizures (convulsions);

• black, bloody, or tarry stools;

• a blistering skin rash;

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

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects of aldesleukin may include:

• rash;

• chills;

• felling like you might pass out;

• diarrhea, vomiting, nausea;

• decreased urination;

• abnormal blood tests;

• easy bruising, unusual bleeding, purple or red spots under your skin;

• shortness of breath; or

• confusion.

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 can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Using aldesleukin with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can affect aldesleukin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

If you are having x-rays, tell the doctor that you are receiving aldesleukin therapy.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.