Note: This document contains side effect information about aldesleukin. Some dosage forms listed on this page may not apply to the brand name Proleukin.

Summary

Common side effects of Proleukin include: supraventricular tachycardia, acute respiratory distress syndrome, congestive heart failure, exfoliative dermatitis, infection, pulmonary congestion, pulmonary infiltrates, respiratory system disorder, cardiac arrhythmia, drowsiness, edema, abdominal pain, acidosis, altered blood pressure, anemia, anxiety, asthenia, asymptomatic ecg changes, cardiovascular disorder, confusion, diarrhea, dizziness, dyspnea, enlargement of abdomen, fever, hyperbilirubinemia, hypocalcemia, hypomagnesemia, hypotension, increased cough, increased serum alkaline phosphatase, increased serum aspartate aminotransferase, increased serum creatinine, leukopenia, nausea, oliguria, pain, peripheral edema, pruritus, pulmonary disease, rales, rhinitis, rhonchi, skin rash, stomatitis, tachycardia, thrombocytopenia, vasodilation, vomiting, weight gain, anorexia, chills, and malaise. Continue reading for a comprehensive list of adverse effects.

Applies to aldesleukin: intravenous powder for solution.

Serious side effects of Proleukin

Along with its needed effects, aldesleukin (the active ingredient contained in Proleukin) 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:

More common

• Agitation
• confusion
• diarrhea
• dizziness
• drowsiness
• fever or chills
• mental depression
• nausea and vomiting
• shortness of breath
• sores in the mouth and on lips
• tingling of the hands or feet
• unusual decrease in urination
• unusual tiredness or weakness
• weight gain of 5 to 10 pounds or more

Less common

• Bloating and stomach pain
• blurred or double vision
• faintness
• fast or irregular heartbeat
• loss of taste
• rapid breathing
• redness, swelling, and soreness of the tongue
• trouble with speaking
• yellow eyes and skin

Rare

• Changes in menstrual periods
• clumsiness
• coldness
• convulsions (seizures)
• listlessness
• muscle aches
• pain or redness at injection site
• sudden inability to move
• swelling in the front of the neck
• swelling of the feet or lower legs
• weakness

Less common

• Black, tarry stools
• blisters on the skin
• blood in the urine
• bloody vomit
• chest pain
• cough or hoarseness
• lower back or side pain
• painful or difficult urination
• pinpoint red spots on the skin
• stomach pain (severe)
• unusual bleeding or bruising

Other side effects of Proleukin

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:

More common

• Dry skin
• loss of appetite
• skin rash or redness with burning or itching, followed by peeling
• unusual feeling of discomfort or illness

Less common

• Constipation
• headache
• joint pain
• muscle pain

For Healthcare Professionals

Applies to aldesleukin: intravenous powder for injection.

Immunologic

Very common (10% or more): Anti-aldesleukin (the active ingredient contained in Proleukin) antibodies (74%)

Common (1% to 10%): Neutralizing antibodies^[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]

General

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]

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]