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Proleukin Side Effects

Generic name: aldesleukin

Medically reviewed by Drugs.com. Last updated on Feb 18, 2024.

Note: This document provides detailed information about Proleukin Side Effects associated with aldesleukin. Some dosage forms listed on this page may not apply specifically to the brand name Proleukin.

Applies to aldesleukin: intravenous powder for solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (powder for solution)

Warning: Capillary Leak Syndrome (CLS), Neurologic Toxicities and Serious Infections. Capillary leak syndrome (CLS), including life threatening or fatal reactions, has occurred in patients treated with aldesleukin.

Do not administer aldesleukin to patients with significant cardiac, pulmonary, renal, and hepatic impairment.

Administer aldesleukin in a hospital setting with an intensive care facility.

Withhold or discontinue aldesleukin as recommended.Neurologic toxicities, which may be life-threatening or result in coma or permanent neurological deficits, have occurred in patients treated with aldesleukin.

Withhold or discontinue aldesleukin as recommended.Serious infections including sepsis and bacterial endocarditis have occurred in patients treated with aldesleukin.

Treat pre-existing bacterial infections prior to initiation of aldesleukin therapy and withhold aldesleukin as recommended.

Serious side effects of Proleukin

Along with its needed effects, aldesleukin (the active ingredient contained in Proleukin) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking aldesleukin:

More common

  • anxiety
  • black, tarry stools
  • bleeding gums
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blood in the urine or stools
  • blue lips, fingernails, or skin
  • blurred vision
  • change in consciousness
  • chest pain, discomfort, or tightness
  • confusion
  • coughing or vomiting blood
  • decreased urine output
  • dilated neck veins
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • fast, pounding, or irregular heartbeat or pulse
  • fever or chills
  • loss of appetite
  • loss of consciousness
  • lower back or side pain
  • mood or mental changes
  • muscle cramps in the hands, arms, feet, legs, or face
  • nausea
  • no blood pressure or pulse
  • numbness and tingling around the mouth, fingertips, or feet
  • pain or discomfort in the arms, jaw, back, or neck
  • painful or difficult urination
  • pale skin
  • palpitations
  • persistent bleeding or oozing from puncture sites, mouth, or nose
  • pinpoint red spots on the skin
  • rapid weight gain
  • seizures
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach cramps
  • stopping of the heart
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • swollen glands
  • tingling of the hands or feet
  • tremor
  • trouble breathing
  • unconsciousness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • vomiting

Rare

  • agitation
  • bloating
  • burning, numbness, tingling, or painful sensations
  • changes in skin color
  • clumsiness
  • constipation
  • delusions of persecution, mistrust, suspiciousness, or combativeness
  • depression
  • dry, shriveled appearance of skin on the hands, lower legs, or feet
  • heartburn
  • heart murmur
  • hostility
  • indigestion
  • irritability
  • lethargy
  • low body temperature
  • muscle twitching
  • pains in stomach, side, or abdomen, possibly radiating to the back
  • severe stomach pain, cramping, or burning
  • shivering
  • slow or irregular heartbeat
  • stupor
  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
  • unsteadiness or awkwardness
  • vomiting of blood or material that looks like coffee grounds
  • weak or feeble pulse
  • weakness in the arms, hands, legs, or feet
  • yellow eyes or skin

Incidence not known

  • back pain
  • blistering, peeling, or loosening of the skin
  • dark urine
  • difficulty swallowing
  • hallucinations
  • hives, itching skin rash
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • nerve pain
  • nervousness
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red irritated eyes
  • red skin lesions, often with a purple center
  • sensitivity to heat
  • stiff neck
  • stroke
  • trouble sleeping
  • upper right abdominal or stomach pain

Other side effects of Proleukin

Some side effects of aldesleukin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • general feeling of discomfort or illness
  • lack or loss of strength
  • sneezing
  • stuffy or runny nose
  • swelling or inflammation of the mouth

Incidence not known

  • burning feeling in chest or stomach
  • muscular tenderness or wasting
  • tenderness in the stomach area

For healthcare professionals

Applies to aldesleukin: intravenous powder for injection.

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]

Cardiovascular

Gastrointestinal

Renal

Other

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]

Dermatologic

Hepatic

Hematologic

Psychiatric

Endocrine

Metabolic

Nervous system

Immunologic

Hypersensitivity

Musculoskeletal

Ocular

References

1. (2001) "Product Information. Proleukin (aldesleukin)." Chiron Therapeutics

Further information

Proleukin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.