Posted on December 29th, 2009 by
Class: Biologic therapy
Generic Name: Aldesleukin (al-des-LOO-kin), Interleukin-2, recombinant human interleukin 2, IL-2
Trade Name: Proleukin®
For which conditions is this drug approved?
Aldesleukin is currently FDA approved for the treatment of metastatic melanoma and metastatic renal cell carcinoma.
It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action?
Aldesleukin belongs to a group of agents called biologic response modifiers. Aldesleukin is similar in structure to a naturally occurring substance in the body, called interleukin-2. Aldesleukin produces anti-cancer effects by stimulating the immune system, which helps to attack the cancer.
How is aldesleukin typically given (administered)?
Aldesleukin may be administered intravenously (into a vein) or subcutaneously (with an injection under the skin). The dose of aldesleukin depends on several factors, including the condition being treated, the size of the patient, the particular regimen being used, and the overall health of the patient. During administration, patients receiving aldesleukin may experience serious side effects attributed to a condition called capillary leak syndrome. Capillary leak syndrome may ultimately lead to severely low blood pressure and reduced blood flow, heart and lung abnormalities, fluid retention, mental changes, kidney abnormalities and/or gastrointestinal abnormalities. Capilliary leak syndrome may be severe and can result in death. Therefore, it is advised that patients treated with higher doses of aldesleukin be closely supervised during administration, with an intensive care facility and specialists trained in cardiopulmonary care or intensive care medicine readily available. Patients should tell their healthcare provider immediately if they are experiencing light-headedness, dizziness, rapid swelling or weight gain, difficulty breathing, chest pain, a noticeable change in heart beat and/or a significantly reduced volume of urine output.
How are patients typically monitored?
Patients will usually have scheduled meetings with their healthcare provider while they are being treated with aldesleukin. During treatment with aldesleukin, patients are monitored closely, especially those patients being treated with higher doses. Monitoring may include blood draws to measure the levels of blood cells, electrolyte levels and the functions of several organ systems, such as the kidneys or liver. In addition, assessments will be done to monitor lung and heart function, weight changes, swelling, urine volume output, and levels of specific proteins in the urine to test kidney function. Patients may also undergo scans or other measures to assess response to therapy.
What are the common (occur in 30% or more of patients) side effects of treatment with aldesleukin?
• Low platelet levels – increases risk of bleeding
• Low red blood cell levels – increases risk of anemia
• Low white blood cell levels- increases risk of infection
• Low blood pressure
• Redness or rash of the face and body
• Nausea and vomiting
• Changes in heartbeat
• Water retention, (edema, weight gain)
• Mental changes, such as confusion, memory loss, or drowsiness
• Changes in liver function tests, liver damage
• Aches or pains anywhere in the body
• Reduced volumes of urine, may lead to renal failure
• Breathing problems or lung congestion
• Changes in thyroid function
What are the less common (occur in 10% to 29% of patients) side effects of treatment with aldesleukin?
• Loss of appetite
• Mouth sores
• Fatigue or weakness
• Fluctuations in weight
• Peeling or dry skin
• Enlargement of the abdomen
• Changes in electrolyte levels (magnesium, calcium, phosphate, potassium, sodium)
• Gastrointestinal bleeding
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• Maintain adequate rest and nutrition.
• If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
• Wash hands often to reduce the risk of infection.
• Avoid activities that may cause injury or bruising.
• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
• Eat small meals frequently to help alleviate nausea.
• For mouth sores, patients should rinse their mouth three times a day with a salt and soda solution (8 ounces of water mixed with ½ to 1 tsp baking soda and/or ½ to 1 tsp salt) and brush their teeth with a soft toothbrush to help prevent the development of mouth sores.
• Avoid alcohol to reduce changes in mental status.
Are there any special precautions patients should be aware of before starting therapy?
• Patients should tell their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, infection, heart disease, kidney disease, liver disease, lung disease, thyroid disease, etc.) as they may worsen with this drug.
• Patients should inform their physician if they have ever had convulsions or seizures.
• Patients should inform their physician about any other medication they are taking (whether prescription or over the counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
• Patients should use caution when driving or operating heavy machinery, as aldesleukin may affect alertness and may cause dizziness and drowsiness.
When should patients notify their physician?
• Difficulty or changes in breathing
• Sudden weight gain or swelling
• Dizziness or light-headedness
• Significantly reduced urine volume
• Irregular, rapid or slow heartbeat
• Chest pain
• Flu or cold-like symptoms: fever, chills, sore throat or mouth, cough
• Signs of infection – redness, swelling, pus, tenderness
• Severe and prolonged fatigue
• Severe and prolonged nausea and vomiting or diarrhea
• Severe pain
• Sustained confusion or mental changes, irritability
• Yellowing of the skin or eyes
• Severe or prolonged headache
• Tarry or red stools
• Easy bruising or bleeding
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
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