Leach M W, Rybak M E, Rosenblum I Y
Schering-Plough Research Institute, Lafayette, New Jersey 07848, USA.
Clin Immunol Immunopathol. 1997 Apr;83(1):12-4. doi: 10.1006/clin.1997.4304.
The safety and tolerability of Escherichia coli-derived recombinant human interleukin-4 (rhuIL-4) have been evaluated in phase I and phase II studies in human patients with a variety of malignancies. Clinical trials have demonstrated that subcutaneous administration of rhuIL-4 is safe and well tolerated at doses as high as 5 micrograms/kg/day and as high as 10 micrograms/kg when administered 3 times/week. Although preclinical safety studies in cynomolgus monkeys demonstrated a number of adverse effects following repeated daily dosing with rhuIL-4, similar effects have generally not been observed in human patients.
