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Proleukin (Aldesleukin) - Side Effects and Adverse Reactions



The rate of drug-related deaths in the 255 metastatic RCC patients who received single-agent PROLEUKIN® (aldesleukin) was 4% (11/255); the rate of drug-related deaths in the 270 metastatic melanoma patients who received single-agent PROLEUKIN was 2% (6/270).

The following data on common adverse events (reported in greater than 10% of patients, any grade), presented by body system, decreasing frequency and by preferred term (COSTART) are based on 525 patients (255 with renal cell cancer and 270 with metastatic melanoma) treated with the recommended infusion dosing regimen.


Body System %
Body System %
Body as a Whole Metabolic and Nutritional Disorders
Chills 52 Bilirubinemia 40
Fever 29 Creatinine increase 33
Malaise 27 Peripheral edema 28
Asthenia 23 SGOT increase 23
Infection 13 Weight gain 16
Pain 12 Edema 15
Abdominal pain 11 Acidosis 12
Abdomen enlarged 10 Hypomagnesemia 12
Cardiovascular Hypocalcemia 11
Hypotension 71 Alkaline phosphatase increase 10
Tachycardia 23 Nervous
Vasodilation 13 Confusion 34
Supraventricular tachycardia 12 Somnolence 22
Cardiovascular disordera  11 Anxiety 12
Arrhythmia 10 Dizziness 11
Digestive Respiratory
Diarrhea 67 Dyspnea 43
Vomiting 50 Lung disorderb  24
Nausea 35 Respiratory disorderc  11
Stomatitis 22 Cough increase 11
Anorexia 20 Rhinitis 10
Nausea and vomiting 19 Skin and Appendages
Hemic and Lymphatic Rash 42
Thrombocytopenia 37 Pruritus 24
Anemia 29 Exfoliative dermatitis 18
Leukopenia 16 Urogenital  
Oliguria 63
a Cardiovascular disorder: fluctuations in blood pressure, asymptomatic ECG changes, CHF.
b Lung disorder: physical findings associated with pulmonary congestion, rales, rhonchi.
c Respiratory disorder: ARDS, CXR infiltrates, unspecified pulmonary changes.

The following data on life-threatening adverse events (reported in greater than 1% of patients, grade 4), presented by body system, and by preferred term (COSTART) are based on 525 patients (255 with renal cell cancer and 270 with metastatic melanoma) treated with the recommended infusion dosing regimen.


Body System # (%)
Body System # (%)
Body as a Whole Metabolic and
Nutritional Disorders
Fever 5 (1%) Bilirubinemia 13 (2%)
Infection 7 (1%) Creatinine increase 5 (1%)
Sepsis 6 (1%) SGOT increase 3 (1%)
Cardiovascular Acidosis 4 (1%)
Hypotension 15 (3%) Nervous
Supraventricular tachycardia 3 (1%) Confusion 5 (1%)
Cardiovascular disordera  7 (1%) Stupor 3 (1%)
Myocardial infarct 7 (1%) Coma 8 (2%)
Ventricular tachycardia 5 (1%) Psychosis 7 (1%)
Heart arrest 4 (1%) Respiratory
Digestive Dyspnea 5 (1%)
Diarrhea 10 (2%) Respiratory disorderc 14 (3%)
Vomiting 7 (1%) Apnea 5 (1%)
Hemic and Lymphatic Urogenital
Thrombocytopenia 5 (1%) Oliguria 33 (6%)
Coagulation disorderb  4 (1%) Anuria 25 (5%)
Acute kidney failure 3 (1%)
a Cardiovascular disorder: fluctuations in blood pressure.
b Coagulation disorder: intravascular coagulopathy.
c Respiratory disorder: ARDS, respiratory failure, intubation.

The following life-threatening (grade 4) events were reported by <1% of the 525 patients: hypothermia; shock; bradycardia; ventricular extrasystoles; myocardial ischemia; syncope; hemorrhage; atrial arrhythmia; phlebitis; AV block second degree; endocarditis; pericardial effusion; peripheral gangrene; thrombosis; coronary artery disorder; stomatitis; nausea and vomiting; liver function tests abnormal; gastrointestinal hemorrhage; hematemesis; bloody diarrhea; gastrointestinal disorder; intestinal perforation; pancreatitis; anemia; leukopenia; leukocytosis; hypocalcemia; alkaline phosphatase increase; BUN increase; hyperuricemia; NPN increase; respiratory acidosis; somnolence; agitation; neuropathy; paranoid reaction; convulsion; grand mal convulsion; delirium; asthma, lung edema; hyperventilation; hypoxia; hemoptysis; hypoventilation; pneumothorax; mydriasis; pupillary disorder; kidney function abnormal; kidney failure; acute tubular necrosis.

In an additional population of greater than 1,800 patients treated with PROLEUKIN-based regimens using a variety of doses and schedules (e.g., subcutaneous, continuous infusion, administration with LAK cells) the following serious adverse events were reported: duodenal ulceration; bowel necrosis; myocarditis; supraventricular tachycardia; permanent or transient blindness secondary to optic neuritis; transient ischemic attacks; meningitis; cerebral edema; pericarditis; allergic interstitial nephritis; tracheo-esophageal fistula.

In the same clinical population, the following fatal events each occurred with a frequency of <1%: malignant hyperthermia; cardiac arrest; myocardial infarction; pulmonary emboli; stroke; intestinal perforation; liver or renal failure; severe depression leading to suicide; pulmonary edema; respiratory arrest; respiratory failure. In patients with both metastatic RCC and metastatic melanoma, those with ECOG PS of 1 or higher had a higher treatment-related mortality and serious adverse events.

Most adverse reactions are self-limiting and, usually, but not invariably, reverse or improve within 2 or 3 days of discontinuation of therapy. Examples of adverse reactions with permanent sequelae include: myocardial infarction, bowel perforation/infarction, and gangrene.

In post-marketing experience, the following serious adverse events have been reported in a variety of treatment regimens that include interleukin-2: anaphylaxis; cellulitis; injection site necrosis; retroperitoneal hemorrhage; cardiomyopathy; cerebral hemorrhage; fatal endocarditis; hypertension; cholecystitis; colitis; gastritis; hepatitis; hepatosplenomegaly; intestinal obstruction; hyperthyroidism; neutropenia; myopathy; myositis; rhabdomyolysis; cerebral lesions; encephalopathy; extrapyramidal syndrome; insomnia; neuralgia; neuritis; neuropathy (demyelination); urticaria; pneumonia (bacterial, fungal, viral).

Exacerbation or initial presentation of a number of autoimmune and inflammatory disorders have been reported (see “WARNINGS” section, “PRECAUTIONS” section, “Drug Interactions” subsection). Persistent but nonprogressive vitiligo has been observed in malignant melanoma patients treated with interleukin-2. Synergistic, additive and novel toxicities have been reported with PROLEUKIN used in combination with other drugs. Novel toxicities include delayed adverse reactions to iodinated contrast media and hypersensitivity reactions to antineoplastic agents (see “PRECAUTIONS” section, “Drug Interactions” subsection).

Experience has shown the following concomitant medications to be useful in the management of patients on PROLEUKIN therapy: a) standard antipyretic therapy, including nonsteroidal anti-inflammatories (NSAIDs), started immediately prior to PROLEUKIN to reduce fever. Renal function should be monitored as some NSAIDs may cause synergistic nephrotoxicity; b) meperidine used to control the rigors associated with fever; c) H2 antagonists given for prophylaxis of gastrointestinal irritation and bleeding; d) antiemetics and antidiarrheals used as needed to treat other gastrointestinal side effects. Generally these medications were discontinued 12 hours after the last dose of PROLEUKIN.

Patients with indwelling central lines have a higher risk of infection with gram positive organisms.9-11 A reduced incidence of staphylococcal infections in PROLEUKIN studies has been associated with the use of antibiotic prophylaxis which includes the use of oxacillin, nafcillin, ciprofloxacin, or vancomycin. Hydroxyzine or diphenhydramine has been used to control symptoms from pruritic rashes and continued until resolution of pruritus. Topical creams and ointments should be applied as needed for skin manifestations. Preparations containing a steroid (e.g., hydrocortisone) should be avoided. NOTE: Prior to the use of any product mentioned, the physician should refer to the package insert for the respective product.


Below is a sample of reports where side effects / adverse reactions may be related to Proleukin. The information is not vetted and should not be considered as verified clinical evidence.

Possible Proleukin side effects / adverse reactions in 48 year old male

Reported by a pharmacist from United States on 2011-10-05

Patient: 48 year old male weighing 110.0 kg (242.0 pounds)

Reactions: Metastatic Malignant Melanoma, Cardio-Respiratory Arrest, Drug Intolerance, Neoplasm Progression

Adverse event resulted in: death

Suspect drug(s):

Possible Proleukin side effects / adverse reactions in 59 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-11

Patient: 59 year old male

Reactions: Blood Osmolarity Decreased, Blood Potassium Decreased, Urine Osmolarity Increased, Tachycardia, Hypotension, Inappropriate Antidiuretic Hormone Secretion, Hyponatraemia

Suspect drug(s):
    Indication: Metastases TO Liver

    Dosage: 600000 iu/kg, q8h
    Indication: Malignant Melanoma

    Indication: Metastases TO Lung

Other drugs received by patient: Sodium Chloride

Possible Proleukin side effects / adverse reactions in 59 year old male

Reported by a pharmacist from United States on 2011-10-18

Patient: 59 year old male

Reactions: Inappropriate Antidiuretic Hormone Secretion

Suspect drug(s):
    Dosage: 600000 iu/kg' q8h; iv
    Indication: Malignant Melanoma

    Dosage: 600000 iu/kg' q8h; iv
    Indication: Metastases TO Liver

    Dosage: 600000 iu/kg' q8h; iv
    Indication: Metastases TO Lung

Other drugs received by patient: Sodium Chloride

See index of all Proleukin side effect reports >>

Drug label data at the top of this Page last updated: 2009-12-26

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