When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not receive it if you had an allergic reaction to aldesleukin or interleukin-2, or if you have severe heart, liver, kidney, nerve, lung, or stomach problems.

How to Use This Medicine:
Injectable

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how aldesleukin works. Tell your doctor if you are taking any of the following:
  
  • Asparaginase
  • Blood pressure medicine, such as amlodipine, atenolol, clonidine, hydrochlorothiazide (HCTZ), lisinopril, metoprolol, olmesartan, propranolol
  • Indomethacin
  • Methotrexate
  • Other cancer medicine, such as cisplatin, dacarbazine, doxorubicin, interferon-alfa, tamoxifen
  • Steroid medicine, such as hydrocortisone, methylprednisolone, prednisone
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or if you have kidney problems, liver disease, Crohn disease, a thyroid disorder, low blood pressure, or diabetes. Tell your doctor if you have eye problems, gallbladder problems, high calcium, seizures, any infections, or an autoimmune disorder (such as arthritis, lupus, or scleroderma).
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Rarely, a life-threatening condition called capillary leak syndrome (CLS) could occur immediately after you receive this medicine. CLS can cause low blood pressure, so your doctor will monitor your blood pressure and pulse rate.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Blood in your stools or vomit
• Chest pain, or fast or uneven heartbeat
• Confusion, irritability, or depression
• Decrease in how much or how often you urinate, or painful urination
• Fever, chills, cough, sore throat, and body aches
• Lightheadedness, dizziness, or fainting
• Loss of appetite or stomach pain
• Rapid weight gain, swelling in your hands, ankles, or feet
• Trouble breathing
• Unusual bleeding, bruising, tiredness, or weakness
• Yellow skin or eyes

If you notice these less serious side effects, talk with your doctor:

• Nausea, vomiting, or diarrhea
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088