Aldesleukin Side Effects

Please note - some side effects for Aldesleukin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Aldesleukin - for the Consumer

Aldesleukin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Aldesleukin:

Anxiety; dizziness; general body discomfort; increased cough; infection; loss of appetite; pain; runny nose; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black stools; chest pain; chills; confusion; depression; diarrhea; drowsiness; fainting; fever; heart murmurs or gallops; infrequent urination or inability to urinate; irregular heartbeat; irritability; mood changes; nausea; pain, redness, or swelling at the injection site; pounding in the chest; redness of the tongue; reduced amount of urine; severe dizziness; severe lack of energy; sore throat; sores on the mouth or lips; stomach pain or protrusion; swelling; unusual bruising or bleeding; vomiting; weight gain.

Side Effects by Body System

Cardiovascular

Cardiovascular side effects from aldesleukin have been reported. Many of the adverse cardiovascular events from aldesleukin result from a capillary or vascular leak syndrome. Shifting of fluid into the interstitial spaces results in hypotension, tachycardia, and sometimes congestive heart failure, or myocardial infarction. Besides the vascular leak syndrome and hypotension, direct effects on the myocardium have been noted. These effects include hemodynamic changes as well as myocardial injury with creatine phosphokinase (CPK) elevations and myocarditis secondary to lymphocyte infiltration.

Hypotension resulting from aldesleukin-induced capillary leak syndrome should be managed with careful fluid administration and institution of low-dose dopamine infusions.

Respiratory

Respiratory side effects including respiratory distress resulting from fluid weight gain attributed to the vascular leak syndrome has been reported. Other respiratory effects reported include dyspnea, pulmonary congestion with rales and rhonchi, unspecified pulmonary changes with infiltrates on X-ray, increased cough, and rhinitis.

Nervous system

Nervous system side effects including both acute and chronic neurologic and neuropsychiatric findings have been reported during aldesleukin administration. Patients receiving high-dose therapy have been reported to have become agitated, disoriented, and sometimes comatose. These effects have typically resolved upon discontinuation of the drug. Neuropsychiatric effects including a decrease in cognitive function and memory impairment have been reported in patients receiving continuous-infusion aldesleukin therapy.

Renal

Renal damage attributed to aldesleukin results from the decrease in vascular resistance. Low-dose dopamine helps maintain adequate renal perfusion during aldesleukin therapy and may decrease the incidence of renal failure.

Renal side effects including oliguria and anuria are the predominant adverse events that have been reported in the majority of patients. Acute kidney failure with an increase in creatinine has been reported in 1% of patients.

Hepatic

Hepatic side effects reported with aldesleukin therapy include bilirubinemia, SGOT increase, and alkaline phosphatase increase and hepatosplenomegaly.

Hematologic

Hematopoietic side effects which have been reported include anemia, thrombocytopenia, and leukopenia.

Gastrointestinal

Antiemetics and antidiarrheals are helpful in treating the gastrointestinal side effects and H2-antagonists are often given for prophylaxis of gastrointestinal irritation and bleeding. Mucositis requires diligent oral care, including sodium bicarbonate mouthwashes and nystatin.

Gastrointestinal side effects have included nausea, vomiting, diarrhea, and mucositis. Colon dilatation, perforation, and ischemic necrosis have also been reported but are uncommon.

Dermatologic

Rashes have been treated with either hydroxyzine or diphenhydramine, which can be continued until resolution of the rash. Nonalcoholic-based creams and ointments as well as aloe vera gels may also be applied to skin conditions. Application may begin as early as 48 hours before treatment. Preparations containing steroids should be avoided.

Dermatologic side effects such as erythema, pruritus, and generalized erythroderma have been reported with aldesleukin therapy. In patients with preexisting dermatologic conditions such as psoriasis, exacerbation of the underlying condition has been reported.

General

Meperidine may be helpful for the chills and rigors associated with this flu-like syndrome. Scheduled nonsteroidal anti-inflammatory drugs like acetaminophen and indomethacin can substantially relieve the other symptoms.

General side effects including a flu-like syndrome have been reported in patients receiving aldesleukin. Symptoms include fever, chills, rigors, joint pain, myalgias, malaise, and anorexia.

Other

Other side effects including infection have been reported with aldesleukin treatment (which may be due to the initial drop in lymphocyte levels).

Endocrine

Endocrine side effects including hypothyroidism and hyperthyroidism have been reported with aldesleukin therapy.

Metabolic

Metabolic side effects seen with aldesleukin treatment have included acidosis, hypomagnesemia, hypocalcemia, and hyperuricemia.

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