Aldesleukin Intravenous

al-des-LOO-kin

Intravenous routePowder for Solution

Therapy with aldesleukin for injection should be restricted to patients with normal cardiac and pulmonary functions as defined by thallium stress testing and formal pulmonary function testing. Extreme caution should be used in patients with a normal thallium stress test and a normal pulmonary function test who have a history of cardiac or pulmonary disease.

Aldesleukin should be administered in a hospital setting under the supervision of a qualified physician experienced in the use of anticancer agents. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available.

Aldesleukin administration has been associated with capillary leak syndrome (CLS) which is characterized by a loss of vascular tone and extravasation of plasma proteins and fluid into the extravascular space. CLS results in hypotension and reduced organ perfusion which may be severe and can result in death. CLS may be associated with cardiac arrhythmias (supraventricular and ventricular), angina, myocardial infarction, respiratory insufficiency requiring intubation, gastrointestinal bleeding or infarction, renal insufficiency, edema, and mental status changes.

Aldesleukin treatment is associated with impaired neutrophil function (reduced chemotaxis) and with an increased risk of disseminated infection, including sepsis and bacterial endocarditis. Consequently, preexisting bacterial infections should be adequately treated prior to initiation of aldesleukin therapy. Patients with indwelling central lines are particularly at risk for infection with gram positive microorganisms. Antibiotic prophylaxis with oxacillin, nafcillin, ciprofloxacin, or vancomycin has been associated with a reduced incidence of staphylococcal infections.

Aldesleukin administration should be withheld in patients developing moderate to severe lethargy or somnolence; continued administration may result in coma .

Therapy should be restricted to patients with normal cardiac and pulmonary functions as defined by thallium stress testing and formal pulmonary function testing. Administration has been associated with capillary leak syndrome, which may be severe and can result in death. Treatment is also associated with impaired neutrophil function (reduced chemotaxis) and with an increased risk of disseminated infection, including sepsis and bacterial endocarditis. Administration should be withheld in patients developing moderate to severe lethargy or somnolence; continued administration may result in coma .

Commonly used brand name(s):

In the U.S.

  • Proleukin

Available Dosage Forms:

  • Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Interleukin

Uses For aldesleukin

Aldesleukin is a synthetic (man-made) version of a substance called interleukin-2. Interleukins are produced naturally by cells in the body to help white blood cells work. Aldesleukin is used to treat cancer of the kidney and skin cancer that has spread to other parts of the body.

Aldesleukin causes some other very serious effects in addition to its helpful effects. Some effects can be fatal. For that reason, aldesleukin is given only in the hospital. If severe side effects occur, which is common, treatment in an intensive care unit (ICU) may be necessary. Other effects may not be serious but may cause concern. Before you begin treatment with aldesleukin, you and your doctor should talk about the good aldesleukin will do as well as the risks of using it.

Aldesleukin is to be administered only by or under the immediate supervision of your doctor.

Before Using aldesleukin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For aldesleukin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to aldesleukin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing use of aldesleukin in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. There is no specific information comparing use of aldesleukin in the elderly with use in other age groups.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using aldesleukin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Rotavirus Vaccine, Live

Using aldesleukin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Bacillus of Calmette and Guerin Vaccine, Live
  • Betamethasone
  • Cortisone
  • Deflazacort
  • Dexamethasone
  • Hydrocortisone
  • Influenza Virus Vaccine, Live
  • Measles Virus Vaccine, Live
  • Methylprednisolone
  • Mumps Virus Vaccine, Live
  • Paramethasone
  • Poliovirus Vaccine, Live
  • Prednisolone
  • Prednisone
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Smallpox Vaccine
  • Triamcinolone
  • Typhoid Vaccine
  • Varicella Virus Vaccine
  • Yellow Fever Vaccine

Using aldesleukin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Cisplatin
  • Dacarbazine
  • Interferon Alfa
  • Tamoxifen

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of aldesleukin. Make sure you tell your doctor if you have any other medical problems, especially:

  • Chickenpox (including recent exposure) or
  • Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body
  • Heart disease or
  • Immune system problems or
  • Liver disease or
  • Lung disease or
  • Psoriasis or
  • Underactive thyroid—May be worsened by aldesleukin
  • Infection—Aldesleukin may decrease your body's ability to fight infection
  • Kidney disease—Effects of aldesleukin may be increased because of slower removal from the body
  • Mental problems—Aldesleukin may make them worse
  • Seizures (history of)—Aldesleukin can cause seizures

Proper Use of aldesleukin

Dosing

The dose of aldesleukin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of aldesleukin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions While Using aldesleukin

Aldesleukin can temporarily affect the white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

aldesleukin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Some side effects will have signs or symptoms that you can see or feel. Your doctor may watch for others by doing certain tests.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Fever or chills
  • shortness of breath
Less common
  • Black, tarry stools
  • blisters on skin
  • blood in urine
  • bloody vomit
  • chest pain
  • cough or hoarseness
  • lower back or side pain
  • painful or difficult urination
  • pinpoint red spots on skin
  • stomach pain (severe)
  • unusual bleeding or bruising

Check with your doctor as soon as possible if any of the following side effects occur:

More common
  • Agitation
  • confusion
  • diarrhea
  • dizziness
  • drowsiness
  • mental depression
  • nausea and vomiting
  • sores in mouth and on lips
  • tingling of hands or feet
  • unusual decrease in urination
  • unusual tiredness
  • weight gain of 5 to 10 pounds or more
Less common
  • Bloating and stomach pain
  • blurred or double vision
  • faintness
  • fast or irregular heartbeat
  • loss of taste
  • rapid breathing
  • redness, swelling, and soreness of tongue
  • trouble in speaking
  • yellow eyes and skin
Rare
  • Changes in menstrual periods
  • clumsiness
  • coldness
  • convulsions (seizures)
  • listlessness
  • muscle aches
  • pain or redness at site of injection
  • sudden inability to move
  • swelling in the front of the neck
  • swelling of feet or lower legs
  • weakness

aldesleukin may also cause the following side effects that your doctor will watch for:

More common
  • Anemia
  • heart problems
  • kidney problems
  • liver problems
  • low blood pressure
  • low platelet counts in blood
  • low white blood cell counts
  • other blood problems
  • underactive thyroid

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Dry skin
  • loss of appetite
  • skin rash or redness with burning or itching, followed by peeling
  • unusual feeling of discomfort or illness
Less common
  • Constipation
  • headache
  • joint pain
  • muscle pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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