Rejuvesol

Generic name: sodium pyruvate, inosine, adenine, sodium phosphate, dibasic, and sodium phosphate, monobasic, monohydrate
Dosage form: extracorporeal solution

For Use in the Extracorporeal Rejuvenation of Red Blood Cells

50 mL Glass Vial
NDC 23731-7000-5
PN 7012 12 Vials/Case

Rejuvesol Description

Rejuvesol ® Red Blood Cell Processing Solution ( Rejuvesol ® Solution) is a sterile, non-pyrogenic solution of sodium pyruvate, inosine, adenine, dibasic sodium phosphate, and monobasic sodium phosphate in water for injection intended only for use in the extracorporeal rejuvenation of a unit of red blood cell concentrate (RBC). Each 50 mL of Rejuvesol ® Solution contains sodium pyruvate 0.550 g, inosine 1.34 g, adenine 0.034 g, dibasic sodium phosphate (heptahydrate) 0.730 g, and monobasic sodium phosphate (monohydrate) 0.311 g, in water for injection, pH 6.7-7.4.

Rejuvesol - Clinical Pharmacology

A gradual depletion of red blood cell adenosine triphosphate (ATP) and 2,3 diphosphoglycerate (2,3-DPG) occurs with storage of RBC at 1-6 °C. 1 The level of 2,3-DPG in RBC stored for greater than 14 days is less than 10% of normal 1,2,12,17,18. Rejuvenation of RBC with Rejuvesol ® Solution increases the levels of ATP and 2,3-DPG. 1-5,8,13,17-22,24, 25

An in vitro loss of red blood cells occurs with the preservation and processing of RBC. Thus, the effectiveness of a transfusion is influenced by both the total number of red blood cells transfused and the number of those cells which remain in circulation. Therefore, the "dose" of a transfusion is defined as the percentage of pre-transfusion recovered red blood cells multiplied by the 24 hour post-transfusion survival value.

Rejuvenation is accomplished by incubating the contents of one 50 mL vial of Rejuvesol ® Solution with one unit of RBC (prepared from up to 550 mL of whole blood) for sixty (60) minutes at 37 °C. Citra recommends that the entire 50 mL of Rejuvesol ® Solution be added to a "smaller than normal" RBC as long as the prerejuvenation net packed cell weight is greater than 110 grams. 1,9

INDICATION AND USAGE

Rejuvesol ® Solution is intended only to be used as an in vitro processing solution for the rejuvenation of a unit of RBC. RBC may be rejuvenated after storage in CPD (non-leukocyte reduced), CPDA-1, (non-leukocyte reduced), CPD/ADSOL ® (CPD/AS-1 leukocyte reduced), or CP2D/Nutricel <.