Aldesleukin Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 27, 2024.

Applies to aldesleukin: intravenous powder for solution.

Precautions

It is very important that your doctor check your progress closely and at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control to keep from getting pregnant during treatment this medicine. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may cause a condition called capillary leak syndrome. It can cause fluid to leak from the blood vessels into your body's tissues. Call your doctor right away if you have swelling or puffiness and are urinating less often, trouble breathing, feeling of fullness, dizziness, or feeling faint.

This medicine may cause nerve problems. check with your doctor right away if you have agitation, change in consciousness, loss of consciousness, mental depression or anxiety, nightmare or unusually vivid dreams, seeing, hearing, or feeling things that are not there, trouble walking, trouble with coordination.

Check with your doctor right away if you have chills, confusion, dizziness, lightheadedness, fainting, fast heartbeat, fever, or trouble breathing. These may be signs that you have an infection.

This medicine may cause serious kidney problems (eg, kidney failure). Tell your doctor right away if you have bloody or cloudy urine, nausea, vomiting, trouble breathing, swelling of the face, feet, or lower legs, unusual tiredness or weakness, or unusual weight gain.

Aldesleukin can temporarily affect the white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Colitis (swelling of the colon or bowel) may occur with this medicine. Tell your doctor right away if you have stomach pain or tenderness, watery or bloody diarrhea, or a fever after receiving the medicine.

This medicine may cause thyroid gland problems. Check with your doctor right away if you have change in menstrual periods, decreased sexual ability in males, dry, puffy kin, feeling cold, swelling of front part of the neck, or weight gain.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Serious skin reaction, including Stevens-Johnson syndrome can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

This medicine may cause heart problems. Check with your doctor right away if you have cheat pain or discomfort, fever and chills, fast heartbeat, or trouble breathing.

This medicine may cause serious allergic reaction, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.

This medicine may cause infusion-related reactions, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you start to have a skin rash, dizziness, trouble breathing, chest tightness, swelling in your face or hands, fever or chills while you are receiving this medicine.

Before you have any medical tests, tell the medical doctor that you are receiving aldesleukin injection. This medicine may delay the side effects of iodinated contrast media.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of aldesleukin

Along with its needed effects, aldesleukin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking aldesleukin:

Other side effects of aldesleukin

Some side effects of aldesleukin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to aldesleukin: intravenous powder for injection.

General adverse events

Most adverse reactions were self-limited and usually reversed or improved within 1 to 3 days of therapy cessation; however, some adverse reactions (e.g., myocardial infarction, bowl perforation/infarction, gangrene) have permanent sequelae.^[Ref]

Cardiovascular

• Very common (10% or more): Hypotension (71%), tachycardia (23%), vasodilation (13%), supraventricular tachycardia (12%), cardiovascular disorder (11%), arrhythmia (10%), chest pain
• Common (1% to 10%): Myocardial infarction, ventricular tachycardia, cardiac arrest, cyanosis, transient ECG changes, myocardial ischemia, palpitations, phlebitis, hypertension
• Uncommon (0.1% to 1%): Hemorrhage (including subdural, subarachnoid, cerebral, retroperitoneal), myocarditis, cardiomyopathy, pericardial effusion, thrombosis, thrombophlebitis
• Rare (less than 0.1%): Ventricular hypokinesia
• Frequency not reported: Capillary leak syndrome (CLS), hypoperfusion, bradycardia, ventricular extrasystoles, atrial arrhythmia, second degree AV block, endocarditis, coronary artery disorder, transient ischemic attacks, pericarditis, shock
• Postmarketing reports: Cardiac tamponade^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (67%), vomiting (50%), nausea (35%), stomatitis (22%), nausea with vomiting (19%), abdominal pain (11%), enlarged abdomen (10%)
• Common (1% to 10%): Dysphagia, dyspepsia, constipation, GI bleeding (including rectal hemorrhage), hematemesis, ascites, cheilitis, gastritis
• Uncommon (0.1% to 1%): Pancreatitis, intestinal obstruction, GI perforation (including necrosis/gangrene)
• Rare (less than 0.1%): Activation of quiescent Crohn's disease
• Frequency not reported: GI hemorrhage, bloody diarrhea, GI disorder, intestinal perforation, duodenal ulceration, bowel necrosis, bowel perforation/infarction
• Postmarketing reports: Colitis^[Ref]

Renal

• Very common (10% or more): Oliguria (63%), increased serum creatinine (33%), increased serum urea
• Common (1% to 10%): Anuria, hematuria, renal failure
• Frequency not reported: Increased blood urea nitrogen, crescentic IgA glomerulonephritis, acute tubular necrosis, allergic interstitial nephritis
• Postmarketing reports: Increased hyperuricemia non-protein nitrogen^[Ref]

Other

• Very common (10% or more): Chills (52%), fever (29%), peripheral edema (28%), malaise (27%), asthenia/fatigue (23%), edema (15%), infection (13%), pain (12%), injection site reactions, injection site necrosis, injection site pain, injection site inflammation
• Common (1% to 10%): Sepsis, mucositis, injection site nodule, hypothermia
• Frequency not reported: Peripheral gangrene, atypical reactions to iodinated contrast media, catheter site infections, bacterial infections, malignant hyperthermia^[Ref]

Respiratory

• Very common (10% or more): Dyspnea (43%), lung disorder (24%), respiratory disorder (11%), increased cough (11%), rhinitis (10%)
• Common (1% to 10%): Apnea, respiratory tract infection, lung/pulmonary edema, pleural effusion, hypoxia, hemoptysis, epistaxis, nasal congestion, rhinitis
• Rare (less than 0.1%): Pulmonary embolism
• Frequency not reported: Respiratory acidosis, asthma, hyperventilation, hypoventilation, pneumothorax, trachea-esophageal fistula, respiratory arrest
• Postmarketing reports: Pneumonia (bacterial, fungal, viral)^[Ref]

Lung disorder includes physical findings associated with pulmonary congestion, rales, and rhonchi. Respiratory disorder includes acute respiratory distress syndrome (ARDS), chest x-ray infiltrates, respiratory failure, intubation, and unspecified pulmonary changes.^[Ref]

Dermatologic

• Very common (10% or more): Erythema and rash (42%), pruritus (24%), exfoliative dermatitis (18%), sweating
• Common (1% to 10%): Urticaria, alopecia
• Uncommon (0.1% to 1%): Quincke's edema, vitiligo
• Rare (less than 0.1%): Vesiculobullous rash, Stevens-Johnson syndrome
• Frequency not reported: Bullous pemphigoid, cutaneous and leukocytoclastic hypersensitivity vasculitis
• Postmarketing reports: Cellulitis^[Ref]

Hepatic

• Very common (10% or more): Bilirubinemia (40%), increased SGOT (23%)
• Common (1% to 10%): Acute kidney failure, elevation of hepatic transaminases
• Uncommon (0.1% to 1%): Hyperbilirubinemia, hepatomegaly/hepatosplenomegaly
• Rare (less than 0.1%): Cholecystitis, liver failure
• Frequency not reported: Abnormal liver function tests, abnormal kidney function
• Postmarketing reports: Hepatitis^[Ref]

Hematologic

• Very common (10% or more): Thrombocytopenia (37%), anemia (29%), leukopenia (16%)
• Common (1% to 10%): Coagulopathy (including disseminated intravascular coagulation), eosinophilia
• Uncommon (0.1% to 1%): Neutropenia
• Rare (less than 0.1%): Agranulocytosis, aplastic anemia, hemolytic anemia, neutropenic fever
• Frequency not reported: Leukocytosis, lymphocytosis
• Postmarketing reports: Lymphocytopenia^[Ref]

Psychiatric

• Very common (10% or more): Confusion (34%), anxiety (12%), depression, insomnia
• Common (1% to 10%): Psychosis, irritability, agitation, hallucinations
• Frequency not reported: Paranoid reaction, delirium, suicide^[Ref]

Endocrine

• Very common (10% or more): Hypothyroidism
• Common (1% to 10%): Hyperthyroidism, hyperglycemia
• Uncommon (0.1% to 1%): Hypoglycemia
• Rare (less than 0.1%): Diabetes mellitus
• Frequency not reported: Thyroiditis^[Ref]

Metabolic

• Very common (10% or more): Anorexia (20%), weight gain (16%), acidosis (12%), hypomagnesemia (12%), hypocalcemia (11%), increased alkaline phosphatase (10%), weight loss
• Common (1% to 10%): Hypercalcemia, hyperkalemia, dehydration, elevated lactic dehydrogenase^[Ref]

Nervous system

• Very common (10% or more): Somnolence (22%), dizziness (11%), headache, paresthesia
• Common (1% to 10%): Coma, stupor, neuropathy, syncope, speech disorders, taste loss, lethargy
• Uncommon (0.1% to 1%): Convulsions, paralysis
• Rare (less than 0.1%): Leukoencephalopathy
• Frequency not reported: Grand mal convulsion, meningitis, cerebral edema, mental status changes, ataxia (limb or gait), cortical lesion, cerebral vasculitis, obtundation, cerebrovascular accident, stroke, cerebral vasculitis
• Postmarketing reports: Cerebral lesions, extrapyramidal syndrome, neuralgia, neuritis, demyelinating neuropathy^[Ref]

Immunologic

• Very common (10% or more): Anti-aldesleukin antibodies (74%)
• Common (1% to 10%): Neutralizing antibodies^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Hypersensitivity reactions
• Rare (less than 0.1%): Anaphylaxis^[Ref]

Musculoskeletal

• Common (1% to 10%): Myalgia, arthralgia
• Uncommon (0.1% to 1%): Myasthenia, myopathy, myositis
• Frequency not reported: Scleroderma, inflammatory arthritis, oculobulbar myasthenia gravis
• Postmarketing reports: Rhabdomyolysis^[Ref]

Ocular

• Common (1% to 10%): Conjunctivitis
• Rare (less than 0.1%): Optic nerve disorder (including optic neuritis)
• Frequency not reported: Cortical blindness, mydriasis, pupillary disorder, blindness (permanent and transient)^[Ref]

See also:

Further information

Aldesleukin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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