title: Safety evaluation of recombinant human interleukin-4. II. Clinical studies.
abstract: 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.
authors.affiliation: Schering-Plough Research Institute, Lafayette, New Jersey 07848, USA.
authors.forename: M W
authors.initials: MW
authors.lastname: Leach
authors.forename: M E
authors.initials: ME
authors.lastname: Rybak
authors.forename: I Y
authors.initials: IY
authors.lastname: Rosenblum
mesh_terms: D000818:Animals; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D004305:Dose-Response Relationship, Drug; D006801:Humans; D015847:Interleukin-4 / Q000592:standards* / Q000627:therapeutic use* / Q000633:toxicity; D009369:Neoplasms / Q000188:drug therapy; D011994:Recombinant Proteins / Q000592:standards / Q000627:therapeutic use / Q000633:toxicity
chemical_list: D011994:Recombinant Proteins; D015847:Interleukin-4