Medications and Drugs
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.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
- Drug Interactions - Learn about potential drug interactions you may be exposed to. Drug interactions can occur with prescription drugs, OTC medication, vitamins, herbs, and supplements.
- Melanoma - Get information on melanoma signs, diagnosis, staging, prognosis and symptoms. Learn about early detection, treatment side effects, prevention and see pictures of this form of skin cancer.
- Drugs: What You Should Know About Your Drugs - Find out what you should know about your drugs such as side effects, warnings and precautions, storage information, and if a generic version is as good as the brand name.
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