Aldesleukin Side Effects

Some side effects of aldesleukin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to aldesleukin: intravenous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking aldesleukin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe drowsiness, feeling like you might pass out;

• chest pain, fast or pounding heartbeats;

• runny or stuffy nose, cough, rapid breathing and heart rate, trouble breathing, swelling and pain in any part of your body;

• problems with vision, speech, balance, or coordination;

• mood or behavior changes, confusion, agitation, hallucinations;

• seizures (convulsions);

• swelling, rapid weight gain, little or no urinating;

• black, bloody, or tarry stools;

• a blistering skin rash;

• jaundice (yellowing of the skin or eyes); or

• signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), nausea and vomiting, mouth sores, unusual weakness.

Common side effects may include:

• mild stomach pain, diarrhea, loss of appetite.

• tired feeling; or

• drowsiness, dizziness, anxiety.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to aldesleukin: intravenous powder for injection

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. Postmarketing reports have included lymphocytopenia.

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.

Immunologic

Immunologic side effects have included the formation of anti-aldesleukin antibodies (up to 74%).

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.