What is Proleukin (aldesleukin)?
Proleukin causes side effects in almost every organ. Because of these side effects, Proleukin only can be given to patients who are physically and mentally able to tolerate them.
Common side effects of Proleukin include:
- “capillary leak” (which causes a loss of fluid from the blood, a decrease in the volume of blood, and a decrease in blood pressure),
- abnormal heart rhythms,
- sleep disturbances,
- feeling unwell (malaise),
- loss of appetite,
- visual changes,
- alterations or loss of taste sensation,
- hypothyroidism (low thyroid hormone),
- low platelet count,
- abdominal pain,
- abnormal liver tests,
- and yellowing skin and eyes (jaundice).
Serious side effects of Proleukin include heart attacks and decreases in blood pressure that can be dramatic and even result in death.
Drug interactions of Proleukin include:
- drugs that cause damage to the heart (for example, doxorubicin),
- drugs that damage the kidneys such as aminoglycosides or nonsteroidal anti-inflammatory drugs (NSAIDs),
- drugs that cause liver damage such as isoniazid (INH),
- beta-blockers and other antihypertensive drugs,
- and iodinated contrast media used for some X-rays.
It is unknown if Proleukin can harm a fetus. Because of its known side effects, the manufacturer recommends Proleukin only be given to pregnant women using extreme caution.
What are the important side effects of Proleukin (aldesleukin)?
Aldesleukin causes side effects in almost every organ. Because of these side effects, aldesleukin only can be given to patients who are physically and mentally able to tolerate them. Most of the side effects are due to "capillary leak" which begins immediately after treatment is started.
Capillary leak results in the leakage of proteins out of blood. This causes a loss of fluid from the blood, a decrease in the volume of blood, and a decrease in blood pressure. The decrease in blood pressure can be dramatic and even result in death. More than two-thirds of patients require injectable medications to treat the low blood pressure.
Other important side effects are:
- abnormal heart rhythms,
- heart attacks,
- sleep disturbances,
- loss of appetite,
- visual changes,
- alterations or loss of taste sensation,
- hypothyroidism (low thyroid hormone),
- low platelet count,
- abdominal pain,
- abnormal liver tests, and
Proleukin (aldesleukin) side effects list for healthcare professionals
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.
TABLE 3: ADVERSE EVENTS OCCURRING IN ≥ 10% OF PATIENTS (n=525)
|Body System||% Patients||Body System||% Patients|
|Body as a Whole||Metabolic and Nutritional Disorders|
|Hypotension||71||Alkaline phosphatase increase||10|
|Nausea and vomiting||19||Skin and Appendages|
|Hemic and Lymphatic||Rash||42|
|aCardiovascular disorder: fluctuations in blood pressure, asymptomatic ECG changes, CHF.|
bLung disorder: physical findings associated with pulmonary congestion, rales, rhonchi.
cRespiratory 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.
TABLE 4: LIFE-THREATENING (GRADE 4) ADVERSE EVENTS (n= 525)
|Body System||# (%) Patients||Body System||# (%) Patients|
|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%)|
|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%)|
|Cardiac arrest||4 (1%)||Respiratory|
|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%)|
|aCardiovascular disorder: fluctuations in blood pressure.|
bCoagulation disorder: intravascular coagulopathy.
cRespiratory disorder: ARDS, respiratory failure, intubation.
The following life-threatening (grade 4) events were reported by < 1% of the 525 patients:
- ventricular extrasystoles
- myocardial ischemia
- atrial arrhythmia
- AV block second degree
- pericardial effusion
- peripheral gangrene
- coronary artery disorder
- nausea and vomiting
- liver function tests abnormal
- gastrointestinal hemorrhage
- bloody diarrhea
- gastrointestinal disorder
- intestinal perforation
- alkaline phosphatase increase
- BUN increase
- NPN increase
- respiratory acidosis
- paranoid reaction
- grand mal convulsion
- lung edema
- 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
- supraventricular tachycardia
- permanent or transient blindness secondary to optic neuritis
- transient ischemic attacks
- cerebral edema
- 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
- 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.
- Serum samples from patients in the clinical studies were tested by enzyme-linked immunosorbent assay (ELISA) for anti-aldesleukin antibodies. Low titers of anti-aldesleukin antibodies were detected in 57 of 77 (74%) patients with metastatic renal cell carcinoma treated with an every 8-hour Proleukin regimen and in 33 of 50 (66%) patients with metastatic melanoma treated with a variety of intravenous regimens.
- In a separate study, the effect of immunogenicity on the pharmacokinetics of aldesleukin was evaluated in 13 patients. Following the first cycle of therapy, comparing the geometric mean aldesleukin exposure (AUC) Day 15 to Day 1, there was an average 68% increase in 11 patients who developed anti-aldesleukin antibodies and no change was observed in the antibody-negative patients (n=2). Overall, neutralizing antibodies were detected in 1 patient. The impact of antialdesleukin antibody formation on clinical efficacy and safety of Proleukin is unknown.
- Immunogenicity assay results are highly dependent on several factors including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to Proleukin with the incidence of antibodies to other products may be misleading.
Post Marketing Experience
The following adverse reactions have been identified during post-approval use of Proleukin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Blood and lymphatic system: neutropenia, febrile neutropenia, eosinophilia, lymphocytopenia
- Cardiac: cardiomyopathy, cardiac tamponade
- Endocrine: hyperthyroidism
- Gastrointestinal: gastritis, intestinal obstruction, colitis
- General and administration site conditions: injection site necrosis
- Hepatobiliary: hepatitis, hepatosplenomegaly, cholecystitis
- Immune system: anaphylaxis, angioedema, urticaria
- Infections and infestations: pneumonia (bacterial, fungal, viral), fatal endocarditis, cellulitis
- Musculoskeletal and connective tissue: myopathy, myositis, rhabdomyolysis
- Nervous system: cerebral lesions, encephalopathy, extrapyramidal syndrome, neuralgia, neuritis, demyelinating neuropathy
- Psychiatric: insomnia
- Vascular: hypertension, fatal subdural and subarachnoid hemorrhage, cerebral hemorrhage, retroperitoneal hemorrhage
Exacerbation or initial presentation of a number of autoimmune and inflammatory disorders have been reported. 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.
Experience has shown the following concomitant medications to be useful in the management of patients on Proleukin therapy:
- 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;
- meperidine used to control the rigors associated with fever;
- H2 antagonists given for prophylaxis of gastrointestinal irritation and bleeding;
- 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. 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.
What drugs interact with Proleukin (aldesleukin)?
- Proleukin may affect central nervous function. Therefore, interactions could occur following concomitant administration of psychotropic drugs (e.g., narcotics, analgesics, antiemetics, sedatives, tranquilizers).
- Concurrent administration of drugs possessing nephrotoxic (e.g., aminoglycosides, indomethacin), myelotoxic (e.g., cytotoxic chemotherapy), cardiotoxic (e.g., doxorubicin) or hepatotoxic (e.g., methotrexate, asparaginase) effects with Proleukin may increase toxicity in these organ systems. The safety and efficacy of Proleukin in combination with any antineoplastic agents have not been established.
- In addition, reduced kidney and liver function secondary to Proleukin treatment may delay elimination of concomitant medications and increase the risk of adverse events from those drugs.
- Hypersensitivity reactions have been reported in patients receiving combination regimens containing sequential high dose Proleukin and antineoplastic agents, specifically, dacarbazine, cis-platinum, tamoxifen and interferon-alfa. These reactions consisted of erythema, pruritus, and hypotension and occurred within hours of administration of chemotherapy. These events required medical intervention in some patients.
- Myocardial injury, including myocardial infarction, myocarditis, ventricular hypokinesia, and severe rhabdomyolysis appear to be increased in patients receiving Proleukin and interferonalfa concurrently.
- Exacerbation or the initial presentation of a number of autoimmune and inflammatory disorders has been observed following concurrent use of interferon-alfa and Proleukin, including crescentic IgA glomerulonephritis, oculo-bulbar myasthenia gravis, inflammatory arthritis, thyroiditis, bullous pemphigoid, and Stevens-Johnson syndrome.
- Although glucocorticoids have been shown to reduce Proleukin-induced side effects including fever, renal insufficiency, hyperbilirubinemia, confusion, and dyspnea, concomitant administration of these agents with Proleukin may reduce the antitumor effectiveness of Proleukin and thus should be avoided.
- Beta-blockers and other antihypertensives may potentiate the hypotension seen with Proleukin.
Delayed Adverse Reactions to Iodinated Contrast Media
- A review of the literature revealed that 12.6% (range 11-28%) of 501 patients treated with various interleukin-2 containing regimens who were subsequently administered radiographic iodinated contrast media experienced acute, atypical adverse reactions.
- The onset of symptoms usually occurred within hours (most commonly 1 to 4 hours) following the administration of contrast media. These reactions include fever, chills, nausea, vomiting, pruritus, rash, diarrhea, hypotension, edema, and oliguria.
- Some clinicians have noted that these reactions resemble the immediate side effects caused by interleukin-2 administration, however the cause of contrast reactions after interleukin-2 therapy is unknown. Most events were reported to occur when contrast media was given within 4 weeks after the last dose of interleukin-2. These events were also reported to occur when contrast media was given several months after interleukin-2 treatment.
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- Breast Cancer: Mother-daughter relationships
- Uterine Cancer (Endometrial Cancer)
- Ocular Melanoma
- Bile Duct Cancer (Cholangiocarcinoma)
- Vaginal Cancer
- Bone Cancer
- Inflammatory Breast Cancer
- Cancer: Confronting Cancer with Humor
- Breast Cancer: Early Stage Treatments
- Testicular Cancer
- Prostate Cancer Treatment Update
- Cancer Survival and Attitude with Hamilton Jordan
- Breast Cancer: Early Diagnosis and Prevention
- Colorectal Cancer Issues: An Update with Doctors
- Breast Cancer: A Feisty Women's Discussion
- Cancer and Green Tea
- Cancer Treatment: Writing to Heal with Margie Davis
- Colon Cancer Update
- Breast Cancer: Clinical Trials - Today's Cutting Edge
- Breast Cancer Treatments. Oct. 29, 2002.
- Lung Cancer Q & A
- Cancer: Living Well Despite with Win Boerckel
- Breast Cancer Treatment Update
- Cancer: Emotional Aftershocks: When Cancer Comes Back 10/30/02
- Breast Cancer, Metastatic: Treatment Goals and Therapy Options -- Harold J. Burstein, MD
- Cancers: Children's Cancers
- Colon Cancer Update: James Church, MD
- Breast Cancer: The Male View on Survival and Support
- Breast Cancer, Taking Control: Self-Advocacy 101
- Nutrition: Fighting Cancer With Food
- Cancer: Childhood Cancer Survivors
- Avastin: A New Hope for Halting Cancer?
- Breast Cancer
- Cancer: Journaling to Save Your Life
- Colon Cancer Update with The Cleveland Clinic
- Cancer Research: Going the Distance
- Melanoma: Prevention, Detection, and Treatment
- Cancer Pain Management with Ann Reiner
- Cancer: The Importance of Joining a Cancer Support Group with Selma Schimmel
- Cancer Patients Need Proper Diet and Exercise
- Skin Cancer Melanoma FAQs
- Cancer FAQs
- Beta Carotene Supplements Not the Answer for Cancer or Heart Disease
- Breast Cancer Risk - Reduced With Exercise
- Sun Protection . . . Kids At The Beach
- Skin Cancer Rate Increasing
- Cancer,Stroke & Heart Attack Risks- ReducedThrough Walking
- Herceptin Metastatic Breast Cancer Treatment
- Colon Cancer Prevention And Fiber?
- Esophageal Cancer Linked to Heartburn
- Cigar Smoking ... Heart & Lung Disease & Cancer
- Cancer Care in the Elderly
- Breastfeeding -- Protection from Breast Cancer?
- Hormone Therapy in Survivors of Breast Cancer
- Colon Cancer and Polyp Screening Guidelines
- Melanoma Skin Cancer of U.S. Senator John McCain
- Chronic Viral Hepatitis, Alcoholism, Cirrhosis Linked to Liver Cancer
- GERD Surgery Doesn't Prevent Cancer
- Breast Cancer: Types of Breast Cancer
- Cancer Survivor?
- Elizabeth Edwards has Breast Cancer Alert
- Colon Cancer Silences Howard Keel
- Colon Cancer, The Genetic Factor
- Exercise Improves Breast Cancer Survival
- 5 Causes of Lung Cancer in Non-Smokers
- Dana Reeve Dies of Lung Cancer by Dr. Stoppler
- Brain Cancer Symptoms: Headaches and Seizures
- Endometrial Cancer Symptoms
- Advanced Breast Cancer in Young Women Increasing
- Angelina Jolie's Mastectomy
- How Common Is Stomach Cancer in Women?
- Can Gallbladder Problems Cause Blood Clots?
- Can a CAT Scan Falsely Diagnose Liver Cancer?
- Could Cervical Cancer Recur After Hysterectomy?
- Can Ovarian Cysts Be the Start of Cancer?
- Can an Endometrial Biopsy Diagnose Uterine Cancer?
- Does HIV Cause Colorectal Cancer?
- Does Positive Additude Affect Breast Cancer?
- How Common and Dangerous Is Male Breast Cancer?
- Can You Get Ovarian Cancer after Tubal Ligation?
- Are All Tumors in the Bladder Cancerous?
- Can You Prevent Ovarian Cancer?
- How Do Melanomas Form?
- 10 Testicular Cancer Symptoms and Signs
- Can Headaches Be a Sign of Throat Cancer?
- Is Skin Cancer Lethal?
- Does Hepatitis B Cause Liver Cancer?
- Does BBQ Meat Cause Cancer?
- Does Stress Cause Cancer?
- Can You Get Lung Cancer After Quitting Smoking?
- Skin Changes: How to Spot Skin Cancer
- Skin Cancer Treatment
- Early Bone Cancer Symptoms
- Skin Cancer Symptoms and Signs
- Facts on Breast Cancer Causes, Risk Factors, and Types
- Breast Cancer Symptoms and Signs
- Complementary and Alternative Cancer Treatments
- Breast Cancer Detection
- Bone Cancer Treatment Options and Their Side Effects
- Psoriasis PUVA Therapy Can Increase Melanoma Risk
- Breast Cancer Treatment
- 10 Cancer Symptoms That Men Ignore
- Bladder Cancer Causes, Symptoms, and Signs
- Breast Cancer and Kylie Minogue - Audio Podcast
- Cancer Prevention: The Anticancer Diet
Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.