STABILITY AND COMPATIBILITY OF ANAKINRA WITH INTRAVENOUS CIMETIDINE HYDROCHLORIDE OR FAMOTIDINE IN 0-CENTER-DOT-9-PERCENT SODIUM-CHLORIDE INJECTION

We designed a study to evaluate the stability and compatibility of ana kinra (recombinant human interleukin-1 receptor antagonist) with cimet idine hydrochloride or famotidine in 0.9% sodium chloride injection du ring a 4-h period at room temperature (22 degrees C) and light. Anakin ra was diluted in 0.9% sodium chloride to concentrations of 4 and 36 m g/ml. At each concentration, anakinra was mixed with 3 mg/ml cimetidin e or with 1 mg/ml famotidine, in a 50:50 proportion and stored in plas tic culture vials with polypropylene caps. The mean concentrations of anakinra, cimetidine hydrochloride, and famotidine exceeded 95% of ini tial concentrations throughout the study. No changes were noted in the physical appearance, pH, or the chromatograms during the study period . Thus, anakinra appears to be stable and compatible with cimetidine h ydrochloride or famotidine when diluted into 0.9% sodium chloride inje ction for 4 h at ambient room temperature and light.