aldesleukin, Proleukin (cont.)
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.
Reference: FDA Prescribing Information
Last Editorial Review: 6/13/1999
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