DrugindexOnline^{2nd edition}

Generic Name: Aldesleukin (al-des-LOO-kin)
Brand Name: Proleukin

Proleukin is only to be given to patients with healthy heart and lung function. Your health care provider will perform lab tests to determine if you are a candidate for Proleukin . Proleukin must be given in a hospital setting. Proleukin can cause capillary leak syndrome, a condition that can be life-threatening. If you develop the following signs of capillary leak syndrome, notify your doctor immediately: swelling, severe dizziness, fainting, irregular heartbeat, chest pain, trouble breathing, change in urine amount, mental/mood changes, severe stomach pain, or black stools. Proleukin can also make you prone to serious infections. Before using Proleukin , tell your doctor if you already have any infections. If you develop any of the following signs of infection, notify your doctor immediately: persistent sore throat or fever. Stop using Proleukin and notify your doctor immediately if you are unusually sleepy.

Proleukin is used for:

Treating skin cancer and kidney cancer that has spread to other parts of the body.

Proleukin is an antineoplastic. It works by helping enhance many aspects of the immune system, which helps to decrease growth of the cancer cells.

Do NOT use Proleukin if:

• you are allergic to any ingredient in Proleukin
• you have an organ transplant
• you have kidney failure requiring dialysis
• you have or have a history of an abnormal heart stress test or lung function test, heart rate or rhythm problems, chest pain (angina), or a heart attack
• you have a history of seizures, coma, toxic psychosis, stomach or intestinal bleeding requiring surgery, bowel blood flow problems, or ulcers

Contact your doctor or health care provider right away if any of these apply to you.

Before using Proleukin :

Some medical conditions may interact with Proleukin . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have epilepsy, a central nervous system disorder, or liver or kidney problems
• if you have high calcium levels or you are required to drink a certain amount of fluid
• if you have an infection or autoimmune disease
• if you have an indwelling central line

Some MEDICINES MAY INTERACT with Proleukin . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Many prescription and nonprescription medicines (eg, for vomiting, inflammation, aches and pains, chemotherapy, depression, sedation, psychoactive agents, high blood pressure) may interact with Proleukin , increasing the risk of serious side effects on the kidney, heart, liver, immune system, and nervous system; the effectiveness of Proleukin may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Proleukin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Proleukin :

Use Proleukin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Proleukin is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using this medicine at home, carefully follow the injection procedures taught to you by your health care provider.
• If Proleukin contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Proleukin , contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Proleukin .

Important safety information:

• Proleukin may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Proleukin . Using Proleukin alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• If nausea, vomiting, or loss of appetite occurs, ask your doctor, nurse, or pharmacist for ways to lessen these effects.
• Proleukin may reduce the number of blood cells that are needed for clotting. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
• Proleukin may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. Notify your doctor of any signs of infection, including fever, sore throat, rashes, or chills.
• Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are taking Proleukin . Check with your doctor before anyone in your household has a vaccination.
• LAB TESTS, including complete blood cell counts, kidney and liver tests, and lung function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Proleukin is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Proleukin during pregnancy. It is unknown if Proleukin is excreted in breast milk. Do not breast-feed while taking Proleukin .

Possible side effects of Proleukin :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; dizziness; general body discomfort; increased cough; infection; loss of appetite; pain; runny nose; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black stools; chest pain; chills; confusion; depression; diarrhea; drowsiness; fainting; fever; heart murmurs or gallops; infrequent urination or inability to urinate; irregular heartbeat; irritability; mood changes; nausea; pain, redness, or swelling at the injection site; pounding in the chest; redness of the tongue; reduced amount of urine; severe dizziness; severe lack of energy; sore throat; sores on the mouth or lips; stomach pain or protrusion; swelling; unusual bruising or bleeding; vomiting; weight gain.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Proleukin :

Store Proleukin in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Store away from heat, moisture, and light. Store in the carton until time of use. Reconstituted solution is stable for up to 48 hours. Do not use beyond the expiration date printed on the vial. This product contains no preservatives. Do not store in the bathroom. Brief excursions at temperatures between 59 and 86 degrees F (15 and 30 degrees C) are permitted. Keep Proleukin out of the reach of children and away from pets.

General information:

• If you have any questions about Proleukin , please talk with your doctor, pharmacist, or other health care provider.
• Proleukin is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Proleukin . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.