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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

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