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Proleukin IV

Important Note

Warnings
Uses
Side Effects
Precautions
Interactions
Overdose
Proleukin IV Warnings

Aldesleukin must be given in a hospital setting by a health care professional. It must be used with extreme caution in patients with heart or lung problems.

Infrequently, this medication can cause capillary leak syndrome (CLS), a serious condition that can sometimes be fatal. If you develop any of the following signs of CLS, tell your doctor immediately: swelling, severe dizziness, fainting, irregular heartbeat, chest pain (angina), trouble breathing, change in the amount of urine, mental/mood changes, severe stomach/abdominal pain, black stools.

Aldesleukin can also make you more likely to get serious infections. Before using this drug, tell your doctor if you currently have any infections. Also, tell your doctor immediately if you develop any of the following signs of infection: persistent sore throat, fever.

Rarely, this drug may cause a loss of consciousness. If this drug makes you unusually sleepy, stop using it and tell your doctor immediately.

Proleukin IV Uses

Aldesleukin is used to treat advanced forms of kidney or skin cancer (cancer that has spread to other parts of the body). 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.

OTHER USES: 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 medication may also be used to treat Kaposi's sarcoma.

How to use Proleukin IV

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 therapy 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.

Proleukin IV 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 persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she 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 immediately if any of these unlikely but serious side effects occur: swollen belly, muscle pain/weakness, severe tiredness, confusion, difficulty speaking, trouble walking, vision changes (including temporary blindness), mental/mood changes (e.g., depression, agitation, hallucinations), unusual bleeding/bruising, swelling hands/feet, sudden weight gain, shortness of breath, thirst, flushing, rapid breathing.

Tell your doctor immediately if any of these rare but very serious side effects occur: fast heartbeat, yellowing eyes/skin, dark urine, vomit that looks like coffee grounds.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest/jaw/left arm pain, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.

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

Proleukin IV Precautions

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, heart disease (e.g., fast/irregular heartbeat, recent heart attack, angina), liver disease, lung disease, stomach problems (e.g., ischemic bowel, perforation, bleeding ulcers), high levels of calcium (hypercalcemia), history of organ transplant, seizures.

This medication may worsen certain types of immune system disorders (autoimmune and inflammatory type). Before using this medication, tell your doctor or pharmacist if you have any of the following disorders: a certain bowel disease (Crohn's disease), a certain connective tissue disease (scleroderma), thyroid disorders, arthritis, diabetes, a certain muscle/nerve disease (myasthenia gravis), a certain kidney disorder (glomerulonephritis), gallbladder problems (cholecystitis), a certain disease of blood vessels in the brain (cerebral vasculitis).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

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

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at a greater risk for kidney effects or shortness of breath while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Women who may become pregnant should use an effective form of birth control while using this medication. Discuss the use of birth control and the risks and benefits of using this medication with your doctor.

It is unknown if this medication passes into breast milk. Because of possible harm to a nursing infant, breast-feeding is not recommended while using this medication. Consult your doctor before breast-feeding.

Proleukin IV Interactions

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because very serious interactions may occur: corticosteroids (e.g., hydrocortisone, methylprednisolone, prednisone).

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting aldesleukin.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: blood pressure drugs (e.g., beta blockers such as metoprolol), interferon alfa, tamoxifen, drugs that can cause kidney problems (e.g., indomethacin, aminoglycosides such as gentamicin), other anti-cancer medication (e.g., asparaginase, cisplatin, dacarbazine, methotrexate).

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., risperidone, trazodone).

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

Also report the use of drugs that might increase seizure risk when combined with aldesleukin such as isoniazid (INH), phenothiazines (e.g., thioridazine), theophylline, or tricyclic antidepressants (e.g., amitriptyline), among others. Consult your doctor or pharmacist for details.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Proleukin IV Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES:

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

Your doctor should check your heart, lungs, kidneys, liver, and mental state before you start treatment with this medication. Laboratory and/or medical tests (e.g., complete blood counts, kidney/liver/lung function, chest X-ray, blood pressure, pulse, mental status, weight, urine output) should also be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE:

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule.

STORAGE:

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

MEDICAL ALERT: 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).

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

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