A SAFETY STUDY OF ALBUMEX(R)-5, A HUMAN ALBUMIN SOLUTION PRODUCED BY ION-EXCHANGE CHROMATOGRAPHY

Human serum albumin solutions have been used as plasma replacement flu ids for many years and adverse events associated with their use are ra re. Albumex(R) 5 is a new albumin solution manufactured by a combinati on of the Cohn fractionation process and a chromatographic technique. A multicentre, randomised study was conducted to compare the safety of Albumex(R) 5 and 5% normal serum albumin (5% NSA) in patients undergo ing large volume therapeutic plasmapheresis for a variety of disorders . Up to six exchanges were performed on each patient. A total of 208 e valuable exchanges were performed on 40 patients, 109 5% NSA and 99 Al bumex(R) 5. There were 9 adverse events (reaction rate of 8.3%) in 6 p atients with 5% NSA and 12 events (reaction rate 12.1%) in 8 patients with Albumex(R) 5. The difference is not statistically significant (p = 0.37, Fisher's exact test). None of the adverse events were consider ed serious. Only six reactions were thought to be possibly related to the product and three exchanges were modified as a result of an advers e event; one with Albumex(R) 5 was interrupted and two with 5% NSA wer e slowed. Albumex(R) 5 can be considered to be a safe product with a l ow adverse event rate.