rejuvesol™ (red blood cell processing) Solution
What is rejuvesol Solution?
- A sterile, nonpyrogenic prescription only solution of sodium pyruvate, inosine, adenine, mono- and dibasic sodium phosphate, and is used only as an in vitro processing solution for the rejuvenation of red blood cells (RBCs) concentrate.
- rejuvesol Solution is not for direct administration to humans.
- The only FDA approved rejuvenation solution restoring 2,3-diphosphoglycerate (2,3-DPG) and adenosine triphosphate (ATP) of liquid stored RBC concentrate to fresh levels.
- ATP is required to maintain RBC membrane integrity, flexibility, and deformability, which enables movement through microvasculature to transport O2 to the tissues.1-4
- rejuvesol Solution is recommended after 14 days of liquid storage (for use in specific FDA approved anticoagulant/storage solution combinations, see the IFU) to restore 2,3-DPG and ATP levels prior to transfusion for immediate use, or to cryopreserve rare blood types or autologous RBCs.
Important Safety Information
WARNING AND CONTRAINDICATIONS: rejuvesol Solution is intended only for the extracorporeal rejuvenation of a RBC. It should never be directly administered to humans. rejuvesol Solution must not be added to whole blood because the additional plasma may reduce the effectiveness of the rejuvenation process. Immediately after rejuvenation, RBC must either be washed via an approved protocol prior to transfusion or glycerolized and frozen. RBC which have been rejuvenated, glycerolized, and frozen must be deglycerolized via an approved protocol prior to transfusion. RBC rejuvenated before 6 days of storage may achieve 2,3-DPG levels in excess of 2 times normal and ATP levels in excess of 1.5 times normal. In patients with reduced arterial blood p02 of less than 40 torr, the use of RBC rejuvenated before 6 days of storage are contraindicated because their high 2,3-DPG levels and low oxygen affinity may impair proper oxygenation of the red blood cells in the lung. Rejuvenated RBC are further processed prior to transfusion to remove the un-used portion of rejuvesol Solution, by-products of the rejuvenation process, and any other potential storage related impurities in rejuvesol Solution. CAUTION: RBC collected in CPD or CPDA-1 cannot be leukocyte reduced prior to rejuvenation. Rx Only - Federal (USA) law prohibits dispensing without prescription. For details see Package Insert or call 1-800-299-3411. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch4 or call-1-800-FDA-1088.
- rejuvesol Solution NDA. Data on file at Zimmer Biomet.
- Kim-Shapiro DB, et al. Transfusion. 2011;51(4):844-851
- Hess JR. Transfus Apher Sci. 2010;43(1):51-59
- Diez-Silva M, et al. MRS Bull. 2010;35(5):382-388