Aldesleukin is used to treat kidney or skin cancer. This medication is the same as a substance that your body normally makes (interleukin-2). In the body, this drug is thought to work by affecting the body's natural defenses (immune system). This effect slows or stops cancer cell growth.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for certain other types of cancer (such as Kaposi's sarcoma, neuroblastoma).

This medication is given by injection into a vein over 15 minutes by a health care professional. It may also be given in other ways as directed by your doctor.

This medication is usually given every 8 hours for 5 days in a row. However, your doctor may decide to delay or stop your treatment depending on how you respond to this drug. After this treatment period, you will be given time to rest and recover before getting more of this medication. A course of treatment may include up to 28 doses of this medication. To make sure that you receive each scheduled dose as directed, it is important to keep all of your medical appointments while receiving this medication. Depending on your response, your doctor may decide that a second course would be helpful.

Dosage is based on your medical condition, weight, response to treatment, and your side effects.

See also Warning section.

Fever, chills, stomach upset, dry skin, muscle stiffness, diarrhea, mouth sores, dizziness, drowsiness, headache, weight gain, nausea, vomiting, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• swollen belly
• muscle pain/weakness
• difficulty speaking
• trouble walking
• vision changes (including temporary blindness)
• mental/mood changes (such as confusion, depression, agitation, hallucinations)
• unusual bleeding/bruising
• thirst
• flushing
• rapid breathing
• fast heartbeat
• yellowing eyes/skin
• dark urine
• vomit that looks like coffee grounds
• symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain)

Get medical help right away if you have any very serious side effects, including:

• chest/jaw/left arm pain
• seizures

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before using aldesleukin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney problems (such as glomerulonephritis)
• heart disease (such as fast/irregular heartbeat, recent heart attack, angina)
• liver disease
• lung disease
• stomach/intestinal problems (such as Crohn's disease, ischemic bowel, perforation, bleeding ulcers)
• high levels of calcium (hypercalcemia)
• organ transplant
• thyroid disorders
• a certain connective tissue disease (scleroderma)
• seizures
• arthritis
• diabetes
• gallbladder problems (cholecystitis)
• a certain disease of blood vessels in the brain (cerebral vasculitis)
• a certain muscle/nerve disease (myasthenia gravis)

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

If you are scheduled to have any X-ray or scanning procedure using injectable dye (such as iodinated contrast), tell your doctor that you are using this medication.

Older adults may be at a greater risk for kidney effects or shortness of breath while using this drug.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using aldesleukin. Aldesleukin may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• blood pressure drugs (including beta blockers such as metoprolol)
• corticosteroids (such as hydrocortisone, methylprednisolone, prednisone)
• interferon alfa
• tamoxifen
• drugs that can cause kidney problems (including indomethacin, aminoglycosides such as gentamicin)
• other anti-cancer medication (such as asparaginase, cisplatin, dacarbazine, methotrexate)

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Because there may be breaks in treatment, it is important to keep all medical/infusion appointments.

Lab and/or medical tests (such as complete blood counts, kidney/liver/lung function, chest X-ray, blood pressure, pulse, mental status, weight, urine output) should also be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).