Interleukin-2

Black Box Warnings

The drug should be administered under the supervision of an experienced cancer chemotherapy health care provider in a hospital setting with ICU care

High-dose aldesleukin therapy has been associated with capillary leak syndrome (CLS), resulting in hypotension and reduced organ perfusion, which may be severe and can result in death

Use with extreme caution in patients with history of prior cardiac or pulmonary disease

Impaired neutrophil function is associated with treatment. Patients are at risk for sepsis, bacterial endocarditis, and central line-related gram-positive infections.

Withhold therapy for patients developing moderate-to-severe lethargy or somnolence. Continued treatment may result in coma.

Contraindications

Hypersensitivity, abnormal thallium stress test or pulmonary function test

Organ allografts

Retreatment for those who experienced complications of drug-induced capillary leak syndrome

• Sustained VTach (=5 beats), Cardiac arrhythmias not controlled or unresponsive to management
• Chest pain with ECG changes, consistent with angina/MI; Cardiac tamponade
• Intubation for >72 hr; renal failure requiring dialysis >72 hr
• Coma or toxic psychosis lasting >48 hours
• Repetitive or difficult to control seizures
• Bowel ischemia/perforation; GI bleeding requiring surgery

Cautions

History of cardiac or pulmonary disease

See Package Insert for retreatment guidelines & contraindications

May exacerbate autoimmune disease

Risk of capillary leak syndrome

Risk of reduced neutrophil chemotaxis, resulting in sepsis/infection risk, use prophylaxis if warranted

Hypotension is dose-limiting