GENERIC NAME: aldesleukin

BRAND NAME: Proleukin

DRUG CLASS AND MECHANISM: Aldesleukin is a man-made protein that has the same actions as native human interleukin-2 (IL-2). Interleukins are the messengers by which white blood cells communicate with each other to coordinate inflammation and immunity. Among its actions, IL-2 increases the number and activities of certain types of white blood cells called lymphocytes, monocytes, and macrophages that are involved in inflammation and immunity. For example, lymphocytes fight viral infections, regulate the immune system, and fight cancers. (The exact mechanism by which aldesleukin fights tumors is unknown.) Aldesleukin in given only by injection. Aldesleukin was FDA approved in 1992.

GENERIC AVAILABLE: no

PRESCRIPTION: yes

PREPARATIONS: Vials containing 22 million IU (international units) of aldesleukin as a lyophilized (freeze-dried) powder, with diluent.

STORAGE: The vials should be stored in a refrigerator at 2- 8°C (36-46°F ) before and after reconstitution with diluent. The vials should not be frozen. The solution should be brought to room temperature prior to infusion and used within 48 hours of reconstitution. Since the vials do not contain a preservative, any unused portion must be discarded.

PRESCRIBED FOR: Aldesleukin is used in treating wide-spread (metastatic) cancer of the kidney (renal cell cancer) and skin ( melanoma ). It is being investigated in several other diseases including acute myelogenous leukemia , non- Hodgkin's lymphoma, HIV infection, Kaposi's sarcoma, and leprosy.

DOSING: Aldesleukin is given by slow intravenous infusion or subcutaneously (under the skin).

DRUG INTERACTIONS: Use of aldesleukin with drugs that share similar toxicity and side effects results in shared side effects that are more severe. For example, drugs that cause damage to the heart, e.g. doxorubicin (Adriamycin) can worsen the toxic effects of aldesleukin on the heart. Similarly, drugs that damage the kidneys, e.g., aminoglycosides (Garamycin, Nebcin, Amikin) or nonsteroidal anti-inflammatory drugs such as ibuprofen (Motrin, Advil) can worsen the toxic effects of aldesleukin on the kidneys. Finally, drugs that cause liver damage such as isoniazid (INH). increase the toxic effects of aldesleukin on the liver.

Aldesleukin stimulates the immune system. Corticosteroids, e.g. methylprednisolone (Medrol) and prednisone , inhibit the immune system. Therefore, aldesleukin and corticosteroids will have opposing effects if used together. Use of such combinations, in fact, may decrease the anti-tumor effect of aldesleukin. Nevertheless, when aldesleukin is used, clinicians may use dexamethasone (a very powerful corticosteroid) to decrease side effects of aldesleukin such as dyspnea, confusion, fever, nephrotoxicity, or hepatotoxicity, despite the possible decrease in benefit.

PREGNANCY: It is not known whether aldesleukin can cause harm to the fetus. Because of it known side effects, the manufacturer recommends that it only be given to pregnant women using extreme caution.

NURSING MOTHERS: It is not known whether aldesleukin is excreted in breast milk. Because of it known side effects, the manufacturer recommends that it only be given to pregnant women using extreme caution.

SIDE EFFECTS: When given as an infusion into a vein (intravenously), aldesleukin causes side effects in almost every organ. Because of these side effects, aldesleukin only can be given to patients who are physically and mentally able to tolerate them. Most of the side effects are due to "capillary leak" which begins immediately after treatment is started. Capillary leak results in the leakage of proteins out of blood. This causes a loss of fluid from the blood, a decrease in the volume of blood, and a decrease in blood pressure. The decrease in blood pressure can be dramatic and even result in death. More than two-thirds of patients require injectable medications to treat the low blood pressure.

Other problems associated with capillary leak include congestion in the lungs, difficulty breathing (which can occur in one-half of patients), wheezing, respiratory failure (1 out of every 11 patients), and swelling due to fluid accumulation in various tissues in the body (half of all patients). Abnormal heart rhythms occur in 1 out of every 12 patients, and heart attacks in 1 out of every 50. Bleeding from the stomach, intestines, and kidney or liver damage also can occur. In fact, between two-thirds and three-fourths of all patients receiving aldesleukin develop kidney damage. Most of the side events caused by capillary leak begin to resolve a few hours after stopping aldesleukin therapy.

Three-fourths of all patients receiving aldesleukin have mental changes including paranoia and hallucinations. These are less common if aldesleukin is given subcutaneously. Drowsiness, sleep disturbances, headache, fatigue, weakness, malaise, loss of appetite, visual changes, and alterations or loss of taste sensation also occur.

Between 20 and 50% of patients develop hypothyroidism (low thyroid hormone) which usually requires replacement with thyroid drugs, e.g. levothyroxine (Synthroid; Levoxyl). Anemia occurs in 3 out of every 4 patients and may necessitate blood transfusions. A low platelet count (increasing the risk of bleeding) occurs in two-thirds of patients, and low white blood cell count in one-third. Infection may occur in one-quarter of treated patients and possibly lead to death. Itching occurs in half of all patients and rash in one-quarter. Occasionally, rashes can be severe. Generalized pain occurs in one-half of all patients.

Gastrointestinal side effects occur frequently. Nausea or vomiting occur in 7 out of every 8 patients, diarrhea in 3 out of every 4, ulcerations of the mouth in 1 out of every 3, and abdominal pain or constipation in less than 1 out of every 10. Liver tests become abnormal in 3 out of every 5 persons who receives aldesleukin and jaundice in 1 out of every 9.

When aldesleukin is used subcutaneously, side effects are less common than when it is used in higher doses intravenously. Side effects that occur in at least 1 out of every 10 patients receiving subcutaneous aldesleukin include fever, vomiting, diarrhea, drop in blood pressure, weight gain, and hypothyroidism.

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