Aldesleukin

Capillary Leak Syndrome

  • Restricted to patients with normal cardiac & pulmonary function
  • Experienced physician in Hospital Setting with ICU care
  • Capillary Leak Syndrome (CLS): severe, potentially fatal Increased risk of disseminated infection (e.g.sepsis, bacterial endocarditis): related to impaired neutrophil function
  • Lethargy/Somnolence: Withhold therapy in patients with moderate/severe lethargy as may result in coma

Capillary Leak Syndrome

  • Aldesleukin administration has been associated with capillary leak syndrome (CLS) which is characterized by a loss of vascular tone and extravasation of plasma proteins and fluid into the extravascular space.
  • CLS results in hypotension and reduced organ perfusion which may be severe and can result in death. CLS may be associated with cardiac arrhythmias (supraventricular and ventricular), angina, myocardial infarction, respiratory insufficiency requiring intubation, gastrointestinal bleeding or infarction, renal insufficiency, edema, and mental status changes.
  • Aldesleukin treatment is associated with impaired neutrophil function (reduced chemotaxis) and with an increased risk of disseminated infection, including sepsis and bacterial endocarditis. Consequently, preexisting bacterial infections should be adequately treated prior to initiation of aldesleukin therapy. Patients with indwelling central lines are particularly at risk for infection with gram positive microorganisms. Antibiotic prophylaxis with oxacillin, nafcillin, ciprofloxacin, or vancomycin has been associated with a reduced incidence of staphylococcal infections.

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Withhold Therapy in Lethargy/Somnolence

  • Aldesleukin administration should be withheld in patients developing moderate to severe lethargy or somnolence; continued administration may result in coma.

An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available.

Monitoring data

  • Pre-existing bacterial infections should be treated prior to initiation of therapy. Antibiotic prophylaxis has been used in patients with indwelling central lines to reduce incidence of staphylcoccal infections. This group is at increased risk for infection with gram positive organisms.
  • Baseline normal cardiac and pulmonary function defined by thallium stress testing and formal pulmonary function testing. Use extreme caution in patients with normal test results who have history of cardiac or pulmonary disease.
  • CLS characterized by loss of vascular tone & extravasation of plasma proteins and fluid into extravascular space. May result in hypotension, reduced organ perfusion, arrhtyhmias, angina, MI, respiratory insufficiency, GI bleeding/infarction, renal insufficiency, edema, and/or mental status changes.
  • Baseline testing prior to therapy initiation and daily during drug administration: standard hematological tests (e.g., CBC, differential & platelet counts), blood chemistry (electrolytes, renal/hepatic function), & chest x-rays.
  • Baseline serum creatinine should be < 1>
  • Daily monitoring should include vital signs, weight, fluid intake/output, & cardiac function. Repeat pulmonary monitoring regularly during therapy.
  • If evidence of cardiac ischemia or CHF, hold therapy & repeat thallium testing.

Patient counseling

Package inserts

Additional information

Updated: January 2018