Aldesleukin

IMPORTANT WARNING:

Aldesleukin injection must be given in a hospital or medical facility under the supervision of a doctor who is experienced in giving chemotherapy medications for cancer.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before and during your treatment to see if it is safe for you to receive aldesleukin injection and to check your body's response to aldesleukin injection.

Aldesleukin may cause a severe and life-threatening reaction called capillary leak syndrome (a condition that causes the body to keep excess fluid, low blood pressure, and low levels of a protein [albumin] in the blood) which may result in damage to your heart, lungs, kidneys, and gastrointestinal tract. Capillary leak syndrome may occur immediately after aldesleukin is given. If you experience any of the following symptoms, tell your doctor immediately: swelling of the hands, feet, ankles, or lower legs; weight gain; shortness of breath; fainting; dizziness or lightheadedness; confusion; bloody or black, tarry, sticky stools; chest pain; fast or irregular heartbeat.

Aldesleukin may cause a decrease in the number of white blood cells in the blood. A decrease in the number of white blood cells in your body may increase the risk that you will develop a serious infection. If you experience any of the following symptoms, tell your doctor immediately: fever, chills, sore throat, cough, frequent or painful urination, or other signs of infection.

Aldesleukin may affect the nervous system and can cause coma. If you experience any of the following symptoms, tell your doctor immediately: extreme sleepiness or tiredness.

WHY is this medicine prescribed?

Aldesleukin is used to treat advanced renal cell carcinoma (RCC, a type of cancer that begins in the kidney) that has spread to other parts of your body. Aldesleukin is also used to treat melanoma (a type of skin cancer) that has spread to other parts of your body. Aldesleukin is in a class of drugs known as cytokines. It is a man-made version of a naturally occurring protein that stimulates the body to produce other chemicals which increase the body's ability to fight cancer.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Aldesleukin comes as a powder to be mixed with liquid to be injected over intravenously (into a vein) over 15 minutes by a doctor or nurse in a hospital. It is usually injected every 8 hours for 5 days in a row (a total of 14 injections). This cycle may be repeated after 9 days. The length of treatment depends on how well your body responds to treatment.

Your doctor may need to delay or permanently stop your treatment if you experience certain side effects. You will be carefully monitoring during your treatment with aldesleukin. It is important for you to tell your doctor how you are feeling during your treatment with aldesleukin.

What SPECIAL PRECAUTIONS should I follow?

Before receiving aldesleukin,

• tell your doctor and pharmacist if you are allergic to aldesleukin, any other medications, or any of the ingredients in aldesleukin injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); certain cancer chemotherapy medications such as asparaginase (Elspar), cisplatin (Platinol), dacarbazine (DTIC-dome), doxorubicin (Doxil), interferon-alfa (Pegasys, PEG-Intron), methotrexate (Rheumatrex, Trexall), and tamoxifen (Nolvadex); medications for high blood pressure; medications for nausea and vomiting; narcotics and other pain medications; sedatives, sleeping pills, and tranquilizers; steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); and steroid creams, lotions, or ointments such as hydrocortisone (Cortizone, Westcort). Also tell your doctor and pharmacist about all the medications you are taking so they can check whether any of your medications may increase the risk that you will develop kidney or liver damage during your treatment with aldesleukin.

• tell your doctor if you have ever had seizures, gastrointestinal (GI) bleeding requiring surgical treatment, or other serious GI, heart, nervous system, or kidney problems after you received aldesleukin or if you have ever had an organ transplant (surgery to replace an organ in the body). Your doctor may not want you to receive aldesleukin.

• tell your doctor if you have or have ever had seizures, Crohn's disease, scleroderma (a disease that affects the tissues that support skin and internal organs), thyroid disease, arthritis, diabetes, myasthenia gravis (a disease that weakens muscles), or cholecystitis (inflammation of the gall bladder that causes severe pain).

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving aldesleukin, call your doctor. You should not breast-feed while receiving aldesleukin.

What SPECIAL DIETARY instructions should I follow?

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

What SIDE EFFECTS can this medicine cause?

Aldesleukin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• loss of appetite
• sores in the mouth and throat
• tiredness
• weakness
• dizziness
• general feeling of being unwell
• pain or redness at the place where the injection was given

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• seizures
• chest pain
• extreme worry
• abnormal excitement or agitation
• new or worsening depression
• seeing things or hearing voices that do not exist (hallucinating)
• changes in your vision or speech
• loss of coordination
• decreased alertness
• unusual bruising or bleeding
• extreme sleepiness or tiredness
• difficulty breathing
• wheezing
• stomach pain
• yellowing of the skin or eyes
• decreased urination
• rash
• hives
• itching
• difficulty breathing or swallowing

Aldesleukin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• seizures
• fast or irregular heartbeat
• coma
• decreased urination
• swelling of the face, arms, hands, feet, ankles, or lower legs
• unusual tiredness or weakness
• stomach pain
• vomit that is bloody or looks like coffee grounds
• blood in the stool
• black and tarry stools

What OTHER INFORMATION should I know?

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.