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.
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 side effects of Proleukin?
What are the common side effects of Proleukin?
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).
What are the serious side effects of Proleukin?
Serious side effects of Proleukin include heart attacks and decreases in blood pressure that can be dramatic and even result in death.
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
What drugs interact with Proleukin?
- 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.
Proleukin 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.
Proleukin (aldesleukin) is a man-made protein that has the same action as native human interleukin-2 (IL-2) used to treat cancers of the kidney and skin (melanoma). 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), wheezing, abnormal heart rhythms, drowsiness, paranoia, sleep disturbances, headache, fatigue, weakness, feeling unwell (malaise), loss of appetite, visual changes, alterations or loss of taste sensation, hypothyroidism (low thyroid hormone), anemia, low platelet count, itching, rash, nausea, vomiting, diarrhea, abdominal pain, constipation, abnormal liver tests, and yellowing skin and eyes (jaundice).
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What Is the Survival Rate for Ocular Melanoma?
If your doctor treats ocular melanoma (a kind of eye cancer) before it spreads to other organs, you have an 85% chance of surviving five years after diagnosis. If it’s metastasized to distant organs (as opposed to nearby lymph nodes, for example), the five-year survival rate drops to 13%.
Cancer pain results from the tumor pressing on nerves or invading bones or organs. Cancer treatments like chemotherapy, radiation, or surgery can also cause pain. Over-the-counter pain relievers, prescription medications, radiation, biofeedback, and relaxation techniques are just some treatments for cancer pain.
What Is the Main Cause of Kidney Cancer?
The main cause of kidney cancer is altered DNA or a genetic mutation. These mutations lead to a potentially fatal, uncontrolled cell growth in the kidneys.
Is Skin Cancer Itchy at First?
Skin cancers arise from the skin due to abnormal growth of skin cells. Skin cancer is the common form of cancer in the United States and can be cured effectively if diagnosed and treated in time. Most often, skin cancer develops in parts of the body exposed to the sun, such as the scalp, face, lips, ears, neck, chest, arms and hands and legs (in women).
Sentinel Lymph Node Biopsy for Melanoma
Melanoma is a type of skin cancer that can spread to the surrounding organs and cause death. A sentinel lymph node biopsy (SLNB) is done in patients with melanoma to investigate the spread of the disease.
What Questions Should I Ask My Doctor About Breast Cancer?
A diagnosis of breast cancer can be overwhelming, so it's important to write down all your questions before meeting with your doctor.
Breast Cancer During Pregnancy
Breast cancer occurs in about 1 in every 1,000 pregnant women. Treatment of breast cancer during pregnancy involves surgery, but it is very difficult to protect the baby from the dangerous effects of radiation and chemotherapy. It can be an agonizing to decide whether or not to undergo breast cancer treatment while one is pregnant.
Breast Cancer Clinical Trials
Breast cancer clinical trials are research programs designed to evaluate new medical treatments, drugs, or devices for the treatment of breast cancer. Clinical trials are designed to test the safety and efficacy of new treatments as well as assess potential side effects. Clinical trials also compare new treatment to existing treatments to determine if it's any better. There are many important questions to ask your doctor before taking part in a breast cancer clinical trial.
Breast Cancer in Young Women
About 5% of cases of breast cancer occur in women under the age of 40 years old. Some risk factors for breast cancer in young women include a personal history of breast cancer or breast disease, family history of breast cancer, prior radiation therapy, and the presence of BRCA1/BRCA2 gene mutations. Breast self-exams, clinical breast exams, and screening mammograms may help detect breast cancer. Treatment may include surgery, chemotherapy, radiation, and hormone therapy.
Breast Cancer and Coping With Stress
Being diagnosed with breast cancer is stressful. Learning relaxation techniques, exercising, eating well, getting adequate sleep, receiving psychotherapy, and maintaining a positive attitude can help you cope. Creating documents, such as an advance directive, living will, and durable power of attorney will outline your wishes in the event that you are no longer able to make decisions regarding your care.
What Are the Main Causes of Skin Cancer?
Most skin cancers occur due to repeated and prolonged exposure to the ultraviolet (UV) rays from sunlight. Also, artificial sources, such as tanning beds, can cause skin cancer. UV rays can damage the deoxyribonucleic acid (DNA) inside the skin cells. DNA is the source of instructions for everything that cells do.
Genetic Testing: Families With Breast Cancer
Breast cancer can be a killer and the decision to get tested to see if a patient is prone to the disease should be discussed with a doctor -- particularly if the woman has a history of breast cancer in her family. Genetic testing can only tell so much about breast cancer risk, however.
How Is Skin Cancer Caused?
Skin cancers originate in the skin due to abnormal cell growth. Skin cancer is the most common form of cancer and can be cured effectively if diagnosed and treated early.
Ovarian, Fallopian Tube, Primary Peritoneal Cancer Prevention
Some risk factors for cancer can be avoided, but many cannot. For example, both smoking and inheriting certain genes are risk factors for some types of cancer, but only smoking can be avoided. Regular exercise and a healthy diet may be protective factors for some types of cancer. Avoiding risk factors and increasing protective factors may lower your risk but it does not mean that you will not get cancer. Different ways to prevent cancer are being studied, including: Changing lifestyle or eating habits. Avoiding things known to cause cancer. Taking medicines to treat a precancerous condition or to keep cancer from starting.
How Is Kidney Cancer Diagnosed?
Kidney cancer is usually asymptomatic in earlier stages. The tumor is usually found when a patient undergoes medical tests for another reason. A doctor may order the following tests to confirm the diagnosis.
Treatment & Diagnosis
- Mohs Surgery for Skin Cancer
- Screening Tests for Cancer
- What Conditions Do You Need a Bone Marrow Transplant for?
- Colon and Colorectal Cancer Screening
- Chemotherapy Treatment for Breast Cancer
- Bone Marrow Transplantation for Breast Cancer
- Prostate Cancer Screening
- Genetic Testing for Breast Cancer
- Radiation Therapy for Breast Cancer
- Breast Cancer Follow-Up Self-Exam
- Colon Cancer
- Anal Cancer
- Stomach Cancer
- Liver Cancer
- Pancreatic Cancer
- Throat Cancer
- Mind-Body Medicine for Cancer Patients
- Stomach Cancer
- Ovarian Cancer
- Oral Cancer
- Skin Cancer
- Breast Cancer Husband
- Prostate Cancer
- Bladder Cancer
- Brain Cancer
- Cervical Cancer
- Breast Cancer
- Uterine Cancer (Endometrial Cancer)
- Thyroid Cancer
- Small Intestine Cancer
- Lung Cancer
- Kidney Cancer
- Inflammatory Breast Cancer
- Breast Cancer: Mother-daughter relationships
- Bone Cancer
- Ocular Melanoma
- Bile Duct Cancer (Cholangiocarcinoma)
- Cancer Survival and Attitude with Hamilton Jordan
- Penile Cancer
- Cancer: Confronting Cancer with Humor
- Vaginal Cancer
- Breast Cancer
- Lung Cancer Q & A
- Testicular Cancer
- Breast Cancer: A Feisty Women's Discussion
- Breast Cancer: Early Diagnosis and Prevention
- Avastin: A New Hope for Halting Cancer?
- Nutrition: Fighting Cancer With Food
- Cancer Treatment: Writing to Heal with Margie Davis
- Prostate Cancer Treatment Update
- Cancer and Green Tea
- Colon Cancer Update
- Breast Cancer Treatments. Oct. 29, 2002.
- Breast Cancer: Early Stage Treatments
- Breast Cancer: Clinical Trials - Today's Cutting Edge
- Breast Cancer, Metastatic: Treatment Goals and Therapy Options -- Harold J. Burstein, MD
- Cancer: Emotional Aftershocks: When Cancer Comes Back 10/30/02
- Breast Cancer: The Male View on Survival and Support
- Cancer: Journaling to Save Your Life
- Breast Cancer, Taking Control: Self-Advocacy 101
- Cancer: Childhood Cancer Survivors
- Colon Cancer Update: James Church, MD
- Colorectal Cancer Issues: An Update with Doctors
- Melanoma: Prevention, Detection, and Treatment
- Breast Cancer Treatment Update
- Colon Cancer Update with The Cleveland Clinic
- Cancer Research: Going the Distance
- Cancers: Children's Cancers
- 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
- Cancer: Living Well Despite with Win Boerckel
- Skin Cancer Melanoma FAQs
- Cancer FAQs
- 10 Testicular Cancer Symptoms and Signs
- Cancer Survivor?
- Elizabeth Edwards has Breast Cancer Alert
- Colon Cancer Silences Howard Keel
- 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
- Colon Cancer, The Genetic Factor
- Exercise Improves Breast Cancer Survival
- 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
- Dana Reeve Dies of Lung Cancer by Dr. Stoppler
- Brain Cancer Symptoms: Headaches and Seizures
- 5 Causes of Lung Cancer in Non-Smokers
- Endometrial Cancer Symptoms
- Advanced Breast Cancer in Young Women Increasing
- Angelina Jolie's Mastectomy
- How Common Is Stomach Cancer in Women?
- 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 Gallbladder Problems Cause Blood Clots?
- Can a CAT Scan Falsely Diagnose Liver 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?
- 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
- 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.