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Aldesleukin Side Effects

In Summary

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

For the Consumer

Applies to aldesleukin: intravenous powder for solution

In addition to its needed effects, some unwanted effects may be caused by aldesleukin. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking aldesleukin, check with your doctor or nurse immediately:

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

Minor Side Effects

Some of the side effects that can occur with aldesleukin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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 antibodies (up to 74%)
-Common (1% to 10%): Neutralizing antibodies[Ref]

Cardiovascular

-Very common (10% or more): Hypotension (up to 71%), tachycardia (up to 23%), vasodilation (up to 13%), supraventricular tachycardia (up to 12%), cardiovascular disorder (up to 11%), arrhythmia (up to 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, hypoperfusion, bradycardia, ventricular extrasystoles, atrial arrhythmia, second degree AV block, endocarditis, coronary artery disorder, transient ischemic attacks, pericarditis, shock
-Postmarketing reports: Cardiac tamponade[Ref]

Cardiovascular disorder includes fluctuations in blood pressure, asymptomatic ECG changes, cardiac failure, and congestive heart failure.[Ref]

Gastrointestinal

-Very common (10% or more): Diarrhea (up to 67%), vomiting (up to 50%), nausea (up to 35%), stomatitis (up to 22%), nausea with vomiting (up to 19%), abdominal pain (up to 11%), enlarged abdomen (up to 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 (up to 63%), increased serum creatinine (up to 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 (up to 52%), fever (up to 29%), peripheral edema (up to 28%), malaise (up to 27%), asthenia/fatigue (up to 23%), edema (up to 15%), infection (up to 13%), pain (up to 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

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]

-Very common (10% or more): Dyspnea (up to 43%), lung disorder (up to 24%), respiratory disorder (up to 11%), increased cough (up to 11%), rhinitis (up to 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]

Dermatologic

-Very common (10% or more): Erythema and rash (up to 42%), pruritus (up to 24%), exfoliative dermatitis (up to 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 leukocytoplastic hypersensitivity vasculitis
-Postmarketing reports: Cellulitis[Ref]

Hepatic

-Very common (10% or more): Bilirubinemia (up to 40%), increased SGOT (up to 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 (up to 37%), anemia (up to 29%), leukopenia (up to 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 (up to 34%), anxiety (up to 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 (up to 20%), weight gain (up to 16%), acidosis (up to 12%), hypomagnesemia (up to 12%), hypocalcemia (up to 11%), increased alkaline phosphatase (up to 10%), weight loss
-Common (1% to 10%): Hypercalcemia, hyperkalemia, dehydration, elevated lactic dehydrogenase[Ref]

Nervous system

-Very common (10% or more): Somnolence (up to 22%), dizziness (up to 11%), headache, paraesthesia
-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]

References

1. "Product Information. Proleukin (aldesleukin)." Chiron Therapeutics, Emeryville, CA.

Not all side effects for aldesleukin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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