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Proleukin

Generic Name: aldesleukin (Intravenous route)

al-des-LOO-kin

Intravenous route(Powder for Solution)

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 Proleukin

Aldesleukin injection is anticancer medicine that is used to treat metastatic kidney cancer (cancer that has already spread to the body) and metastatic skin cancer.

Aldesleukin is a man-made version of a substance called interleukin-2. Interleukins are produced naturally by cells in the body to help white blood cells work.

Slideshow: Flashback: FDA Drug Approvals 2013

Aldesleukin causes very serious side effects in addition to its helpful effects. Some effects can be fatal. For that reason, aldesleukin injection 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 benefits this medicine will do as well as the risks of using it.

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

Before Using Proleukin

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

Appropriate studies have not been performed on the relationship of age to the effects of aldesleukin injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aldesleukin injection in the elderly. However, elderly patients are more likely to have shortness of breath or troubled breathing and age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving aldesleukin injection.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal 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

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine 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 this medicine 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.

  • Adenovirus Vaccine Type 4, Live
  • Adenovirus Vaccine Type 7, Live
  • 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
  • Prednisolone
  • Prednisone
  • Rubella Virus Vaccine, Live
  • Smallpox Vaccine
  • Triamcinolone
  • Typhoid Vaccine
  • Varicella Virus Vaccine
  • Yellow Fever Vaccine

Using this medicine 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Abnormal pulmonary function test or
  • Abnormal thallium stress test or
  • Arrhythmia (heart rhythm problem), uncontrolled or unresponsive or
  • Chest pain (with ECG changes), consistent with angina or heart attack or
  • Heart disease (e.g., cardiac tamponade) or
  • Intubation for more than 72 hours or
  • Kidney failure (requiring dialysis for more than 72 hours) or
  • Mental illness (e.g., coma or psychosis for more than 48 hours) or
  • Organ allograft or
  • Seizures, repetitive or uncontrolled or
  • Stomach or bowel problems (e.g., bleeding that requires surgery, blockage, perforation) or
  • Ventricular tachycardia (abnormal heart rhythm problem), sustained—Should not be given to patients with these conditions.
  • Allergic reaction (e.g., Stevens-Johnson syndrome) or
  • Autoimmune disease (e.g., bullous pemphigoid, inflammatory arthritis, scleroderma) or
  • Cerebral vasculitis or
  • Cholecystitis (inflammation or swelling of the gallbladder) or
  • Crohn's disease or
  • Diabetes or
  • Eye problems (e.g., oculo-bulbar myasthenia gravis) or
  • Hypercalcemia (high calcium in the blood) or
  • Hypotension (low blood pressure) or
  • Kidney disease (e.g., crescentic IgA glomerulonephritis) or
  • Liver disease or
  • Lung disease or
  • Seizures, history of or
  • Thyroid disease—Use with caution. May make these conditions worse.
  • Infection—May decrease your body's ability to fight infection.

Proper Use of Proleukin

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.

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. This medicine is given through a needle placed in one of your veins.

Precautions While Using Proleukin

It is very important that your doctor check you closely to see if the medicine is working properly. Blood and urine tests, certain laboratory tests, and chest X-rays will be needed before receiving this medicine and to check for unwanted effects.

Capillary leak syndrome (CLS) may occur immediately after receiving this medicine. Your doctor will monitor your blood pressure and pulse rate frequently to avoid lowering of blood pressure (hypotension).

Tell your doctor or nurse right away if you have unusual drowsiness, dullness, sleepiness, tiredness, weakness, or feeling of sluggishness; or unusual or changes in mood or behavior, such as irritability, confusion, or depression after receiving the medicine. These could be signs of serious medical problems.

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 the 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.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Proleukin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

More common
  • Agitation
  • confusion
  • diarrhea
  • dizziness
  • drowsiness
  • fever or chills
  • mental depression
  • nausea and vomiting
  • shortness of breath
  • sores in the mouth and on lips
  • tingling of the hands or feet
  • unusual decrease in urination
  • unusual tiredness or weakness
  • 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 the tongue
  • trouble with speaking
  • yellow eyes and skin
Rare
  • Changes in menstrual periods
  • clumsiness
  • coldness
  • convulsions (seizures)
  • listlessness
  • muscle aches
  • pain or redness at injection site
  • sudden inability to move
  • swelling in the front of the neck
  • swelling of the feet or lower legs
  • weakness
Less common
  • Black, tarry stools
  • blisters on the skin
  • blood in the urine
  • bloody vomit
  • chest pain
  • cough or hoarseness
  • lower back or side pain
  • painful or difficult urination
  • pinpoint red spots on the skin
  • stomach pain (severe)
  • unusual bleeding or bruising

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.

See also: Side effects (in more detail)

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