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Proleukin

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Proleukin

Proleukin

Proleukin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Proleukin (aldesleukin) is used to treat kidney cancer or skin cancer than has spread to other parts of the body. It is a cancer (antineoplastic) medication. Common side effects include fever, chills, stomach upset, dry skin, muscle stiffness, diarrhea, mouth sores, dizziness, drowsiness, headache, weight gain, nausea/vomiting (may be severe), and loss of appetite.

The recommended Proleukin treatment is 600,000 International Units/kg (0.037 mg/kg) dose administered every 8 hours by a 15-minute intravenous infusion for a maximum of 14 doses. Proleukin may interact with other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, anxiety, or nausea and vomiting), antibiotics, antidepressants, antifungals, anti-malaria medications, antiviral medications, medicines to treat HIV or AIDS, birth control pills or hormone replacement therapy, cholesterol-lowering medications, digoxin and other heart rhythm medications, heart or blood pressure medications, medicines to treat a bowel disorders, medicine to treat a psychiatric disorder, other cancer medications, pain or arthritis medicines (including aspirin, acetaminophen, gold compounds, or nonsteroidal anti-inflammatory drugs [NSAIDs]), seizure medications, steroids, or tuberculosis medications. Other drugs may interact with Proleukin. Tell your doctor all medications and supplements you use. During pregnancy, Proleukin should be used only when prescribed. Women who may become pregnant should use birth control while using this medication; consult your doctor. It is unknown if this medication passes into breast milk. Because of possible harm to a nursing infant, breastfeeding is not recommended while using this medication.

Our Proleukin (aldesleukin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Proleukin in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe drowsiness;
  • feeling like you might pass out;
  • chest pain, fast or pounding heartbeats;
  • runny or stuffy nose, cough, rapid breathing and heart rate, trouble breathing, swelling and pain in any part of your body;
  • problems with vision, speech, balance, or coordination;
  • mood or behavior changes, confusion, agitation, hallucinations;
  • seizures (convulsions);
  • swelling, rapid weight gain;
  • black, bloody, or tarry stools;
  • urinating less than usual or not at all;
  • a blistering skin rash;
  • jaundice (yellowing of the skin or eyes); or
  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), nausea and vomiting, mouth sores, unusual weakness.

Less serious side effects may include:

  • mild stomach pain;
  • tired feeling;
  • drowsiness, dizziness, anxiety; or
  • diarrhea, loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Proleukin (Aldesleukin for Injection) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Proleukin Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Fever, chills, stomach upset, dry skin, muscle stiffness, diarrhea, mouth sores, dizziness, drowsiness, headache, weight gain, nausea, vomiting, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor immediately if any of these unlikely but serious side effects occur: swollen belly, muscle pain/weakness, severe tiredness, confusion, difficulty speaking, trouble walking, vision changes (including temporary blindness), mental/mood changes (e.g., depression, agitation, hallucinations), unusual bleeding/bruising, swelling hands/feet, sudden weight gain, shortness of breath, thirst, flushing, rapid breathing.

Tell your doctor immediately if any of these rare but very serious side effects occur: fast heartbeat, yellowing eyes/skin, dark urine, vomit that looks like coffee grounds.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest/jaw/left arm pain, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Proleukin (Aldesleukin for Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Proleukin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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
  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
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%)
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%)
  Cardiac 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%)    
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: 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.

Immunogenicity

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.

Exacerbation or initial presentation of a number of autoimmune and inflammatory disorders have been reported (See “WARNINGS” section, “PRECAUTIONS” section, “DRUG INTERACTIONS” section). 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” section).

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.

Read the entire FDA prescribing information for Proleukin (Aldesleukin for Injection) »

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Proleukin - User Reviews

Proleukin User Reviews

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Here is a collection of user reviews for the medication Proleukin sorted by most helpful. Patient Discussions FAQs

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.


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