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Proleukin (Aldesleukin) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

PROLEUKIN drug label information in our database does not contain a dedicated section on drug interactions. Please check subsections of WARNINGS AND PRECAUTIONS as well as other sources.

OVERDOSAGE

Side effects following the use of PROLEUKIN® (aldesleukin) appear to be dose-related. Exceeding the recommended dose has been associated with a more rapid onset of expected dose-limiting toxicities. Symptoms which persist after cessation of PROLEUKIN should be monitored and treated supportively. Life-threatening toxicities may be ameliorated by the intravenous administration of dexamethasone, which may also result in loss of the therapeutic effects of PROLEUKIN. 12 NOTE:  Prior to the use of dexamethasone, the physician should refer to the package insert for this product.

CONTRAINDICATIONS

PROLEUKIN® (aldesleukin) is contraindicated in patients with a known history of hypersensitivity to interleukin-2 or any component of the PROLEUKIN formulation.

PROLEUKIN is contraindicated in patients with an abnormal thallium stress test or abnormal pulmonary function tests and those with organ allografts. Retreatment with PROLEUKIN is contraindicated in patients who have experienced the following drug-related toxicities while receiving an earlier course of therapy:

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

REFERENCES

  1. Doyle MV, Lee MT, Fong S. Comparison of the biological activities of human recombinant interleukin-2125 and native interleukin-2. J Biol Response Mod 1985; 4:96-109.
  2. Ralph P, Nakoinz I, Doyle M, et al. Human B and T lymphocyte stimulating properties of interleukin-2 (IL-2) muteins. In: Immune Regulation by Characterized Polypeptides. Alan R. Liss, Inc. 1987; 453-62.
  3. Winkelhake JL and Gauny SS. Human recombinant interleukin-2 as an experimental therapeutic. Pharmacol Rev 1990; 42:1-28.
  4. Rosenberg SA, Mule JJ, Spiess PJ, et al. Regression of established pulmonary metastases and subcutaneous tumor mediated by the systemic administration of high-dose recombinant interleukin-2. J Exp Med 1985; 161:1169-88.
  5. Konrad MW, Hemstreet G, Hersh EM, et al. Pharmacokinetics of recombinant interleukin-2 in humans. Cancer Res 1990; 50:2009-17.
  6. Donohue JH and Rosenberg SA. The fate of interleukin-2 after in vivo administration. J Immunol 1983; 130:2203-8.
  7. Koths K, Halenbeck R. Pharmacokinetic studies on35 S-labeled recombinant interleukin-2 in mice. In: Sorg C and Schimpl A, eds. Cellular And Molecular Biology Of Lymphokines. Academic Press: Orlando, FL, 1985;779.
  8. Gibbons JA, Luo ZP, Hansen ER et al. Quantitation of the renal clearance of interleukin-2 using nephrectomized and ureter ligated rats. J Pharmacol Exp Ther 1995; 272: 119-125.
  9. Bock SN, Lee RE, Fisher B, et al. A prospective randomized trial evaluating prophylactic antibiotics to prevent triple-lumen catheter-related sepsis in patients treated with immunotherapy. J Clin Oncol 1990; 8:161-69.
  10. Hartman LC, Urba WJ, Steis RG, et al. Use of prophylactic antibiotics for prevention of intravascular catheter-related infections in interleukin-2-treated patients. J Natl Cancer Inst 1989; 81:1190-93.
  11. Snydman DR, Sullivan B, Gill M, et al. Nosocomial sepsis associated with interleukin-2. Ann Intern Med 1990; 112:102-07.
  12. Mier JW, Vachino G, Klempner MS, et al. Inhibition of interleukin-2-induced tumor necrosis factor release by dexamethasone: Prevention of an acquired neutrophil chemotaxis defect and differential suppression of interleukin-2 associated side effects. Blood 1990; 76:1933-40.
  13. Choyke PL, Miller DL, Lotze MT, et al. Delayed reactions to contrast media after interleukin-2-immunotherapy. Radiology 1992; 183: 111-114.

Manufactured by:

Chiron Corporation

Emeryville, CA 94608

U.S. License No. 1106

Distributed by:

Chiron Corporation

Emeryville, CA 94608

For additional information, contact Chiron Corporations Professional Services 1-800-244-7668, selection 2.

U.S. Patent Nos. RE 33653; 4,530,787; 4,569,790; 4,604,377; 4,748,234; 4,572,798; 4,853,332; 4,959,314; 5,464,939

© 2000 Chiron Corporation

10000340                                    Revised September 2000

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