SYNONYM(S): Interleukin-2, IL-2

COMMON TRADE NAME(S): PROLEUKIN®

CLASSIFICATION: biological response modifier, cytotoxic¹

Special pediatric considerations are noted when applicable, otherwise adult provisions apply.

MECHANISM OF ACTION:

Aldesleukin is a recombinant interleukin-2 with inhibitory effects on tumour growth. It has been associated with multiple immunologic effects, including activation of cellular immunity with profound lyphocytosis, eosinophilia, and thrombocytopenia, as well as production of cytokines including tumour necrosis factor, interleukin-1, and gamma interferon. Aldesleukin does not appear to be cell-cycle phase specific.²

USES:

*Health Canada approved indication

SPECIAL PRECAUTIONS:

Aldesleukin is contraindicated in patients with one or more of the following conditions²:

• a known history of hypersensitivity to interleukin-2
• an abnormal thallium stress test or abnormal pulmonary function tests
• organ allografts.

Retreatment with aldesleukin is contraindicated if patients have experienced the following toxicities in previous aldesleukin therapy:

• cardiovascular: sustained ventricular tachycardia (>5 beats), cardiac arrhythmia not controlled or unresponsive to management, chest pain with ECG changes consistent with angina or myocardial infarction, cardiac tamponade
• intubation >72 hours
• renal failure requiring dialysis >72 hours
• coma or toxic psychosis lasting >48 hours
• repetitive or difficult to control seizures
• bowel ischemia and/or perforation; GI bleeding requiring surgery

SIDE EFFECTS:

The table includes adverse events that presented during drug treatment but may not necessarily have a causal relationship with the drug. Because clinical trials are conducted under very specific conditions, the adverse event rates observed may not reflect the rates observed in clinical practice. Adverse events are generally included if they were reported in more than 1% of patients in the product monograph or pivotal trials, and/or determined to be clinically important. When placebo-controlled trials are available, adverse events are included if the incidence is >5% higher in the treatment group.

Adapted from standard reference^2,5 unless specified otherwise.

Side effects are dosage and schedule dependent. High dose, IV administration is associated with greater toxicity than with low dose, SC administration.⁵

SUPPLY AND STORAGE:

Injection: single-use vials containing 22 million units (1.3 mg) supplied by Novartis.²

For basic information on the current brand used at the BC Cancer Agency, see Chemotherapy Preparation and Stability Chart in Appendix.

SOLUTION PREPARATION AND COMPATIBILITY:

For basic information on the current brand used at the BC Cancer Agency, see Chemotherapy Preparation and Stability Chart in Appendix.

PARENTERAL ADMINISTRATION:

DOSAGE GUIDELINES:

Refer to protocol by which patient is being treated. Numerous dosing schedules exist and depend on disease, response and concomitant therapy. Guidelines for dosing also include consideration of absolute neutrophil count (ANC). Dosage may be reduced, delayed or discontinued in patients with bone marrow depression due to cytotoxic/radiation therapy or with other toxicities.

Adults:

References:

1. National Institute for Occupational Safety and Health (NIOSH). Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Healthcare Settings. Cincinnati, OH; September 2004.

2. Novartis Pharmaceuticals Canada Inc. PROLEUKIN® product monograph. Dorval, Quebec; 6 July 2006.

3. Sievers EL, Lange BJ, Sondel PM, et al. Children's Cancer Group Trials of Interleukin-2 Therapy to Prevent Relapse of Acute Myelogenous Leukemia. Cancer J Sci Am 2000;6(1):S39.

4. BC Cancer Agency. BC Cancer Agency Benefit List. Vancouver, BC; 1 March 2007.

5. Anonymous. Aldesleukin: Drug Information. In: Rose BD, editor. UpToDate. Wellesley, Massachusetts: UpToDate 15.1; 2007.