Proleukin Side Effects

Generic name: aldesleukin

Medically reviewed by Drugs.com. Last updated on Nov 8, 2024.

Note: This document provides detailed information about Proleukin Side Effects associated with aldesleukin. Some dosage forms listed on this page may not apply specifically to the brand name Proleukin.

Applies to aldesleukin: intravenous powder for solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (powder for solution)

Warning: Capillary Leak Syndrome (CLS), Neurologic Toxicities and Serious Infections. Capillary leak syndrome (CLS), including life threatening or fatal reactions, has occurred in patients treated with aldesleukin.

Do not administer aldesleukin to patients with significant cardiac, pulmonary, renal, and hepatic impairment.

Administer aldesleukin in a hospital setting with an intensive care facility.

Withhold or discontinue aldesleukin as recommended.Neurologic toxicities, which may be life-threatening or result in coma or permanent neurological deficits, have occurred in patients treated with aldesleukin.

Withhold or discontinue aldesleukin as recommended.Serious infections including sepsis and bacterial endocarditis have occurred in patients treated with aldesleukin.

Treat pre-existing bacterial infections prior to initiation of aldesleukin therapy and withhold aldesleukin as recommended.

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 side effects

• anxiety
• black, tarry stools
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine or stools
• blue lips, fingernails, or skin
• blurred vision
• change in consciousness
• chest pain, discomfort, or tightness
• confusion
• coughing or vomiting blood
• decreased urine output
• dilated neck veins
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• fast, pounding, or irregular heartbeat or pulse
• fever or chills
• loss of appetite
• loss of consciousness
• lower back or side pain
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• nausea
• no blood pressure or pulse
• numbness and tingling around the mouth, fingertips, or feet
• pain or discomfort in the arms, jaw, back, or neck
• painful or difficult urination
• pale skin
• palpitations
• persistent bleeding or oozing from puncture sites, mouth, or nose
• pinpoint red spots on the skin
• rapid weight gain
• seizures
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach cramps
• stopping of the heart
• sweating
• swelling of the face, fingers, feet, or lower legs
• swollen glands
• tingling of the hands or feet
• tremor
• trouble breathing
• unconsciousness
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting

Rare side effects

• agitation
• bloating
• burning, numbness, tingling, or painful sensations
• changes in skin color
• clumsiness
• constipation
• delusions of persecution, mistrust, suspiciousness, or combativeness
• depression
• dry, shriveled appearance of skin on the hands, lower legs, or feet
• heartburn
• heart murmur
• hostility
• indigestion
• irritability
• lethargy
• low body temperature
• muscle twitching
• pains in stomach, side, or abdomen, possibly radiating to the back
• severe stomach pain, cramping, or burning
• shivering
• slow or irregular heartbeat
• stupor
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
• unsteadiness or awkwardness
• vomiting of blood or material that looks like coffee grounds
• weak or feeble pulse
• weakness in the arms, hands, legs, or feet
• yellow eyes or skin

Incidence not known

• back pain
• blistering, peeling, or loosening of the skin
• dark urine
• difficulty swallowing
• hallucinations
• hives, itching skin rash
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• nerve pain
• nervousness
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red irritated eyes
• red skin lesions, often with a purple center
• sensitivity to heat
• stiff neck
• stroke
• trouble sleeping
• upper right abdominal or stomach pain

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 side effects

• general feeling of discomfort or illness
• lack or loss of strength
• sneezing
• stuffy or runny nose
• swelling or inflammation of the mouth

Incidence not known

• burning feeling in chest or stomach
• muscular tenderness or wasting
• tenderness in the stomach area

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 (the active ingredient contained in Proleukin) 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]

Further information

Proleukin 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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