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.
- rejuvesol Solution enables hospitals to offer RBCs with restored function. The product restores RBC to fresh levels of 2,3-DPG and ATP which help improve RBC efficiency in delivering O2.
- rejuvesol Solution is recommended after 14 days of liquid storage (in specific FDA approved anticoagulant storage solution. See IFU) to restore 2,3-DPG and ATP levels to facilitate immediate cryopreservation of rare blood types or of autologous RBCs.
rejuvesol Solution Benefits
- Optimizes RBCs O2 delivery. In one survey, the average age of RBC at transfusion was 18 days2. At 14 days, 2,3-DPG is depleted by 98% while ATP declines gradually3,4. rejuvesol Solution restores 2,3-DPG and ATP to fresh levels.
- RBC with 2-2.5 times normal 2,3-DPG can be prepared with rejuvesol Solution on the day of collection or within 6 days of collection. These RBCs will exhibit enhanced oxygen delivery capability.5 (see full warnings and contraindications in the complete Instructions for Use herein)
- Annual costs in the Unites States exceed $14 billion in blood transfusion6. rejuvesol Solution may improve the quality of stored RBC by restoring 2,3-DPG and ATP to fresh levels.
- Rejuvenation with rejuvesol Solution can occur up to red blood cell unit expiration at day 427.
- May help adopt emerging best practices in blood management.
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.
How does rejuvesol Solution work?
- Red blood cells are responsible for transporting and delivering oxygen throughout the body.
- For efficient oxygen delivery, adequate levels of 2,3-DPG and ATP are required7.
- When RBC are stored for greater than 14 days, 2,3-DPG is depleted by 98% while ATP declines gradually4.
- rejuvesol Solution is used to increase 2,3-DPG and ATP levels in stored RBC.
Processing rejuvesol Solution
- Dumont LJ, Herschel L, Roback JD, Zimring JC, Gray AD. Changes in the Metabolic Profiles of Stored RBC Following Treatment With rejuvesol Solution. Transfusion. 2012;52(Suppl):Abstract SP63.
- Biomet (Citra Labs). rejuvesol Solution - Package Insert. October 2013. Available at: http://dailymed.nlm.nih.gov. Accessed April 4, 2014.
- Whitley PH, Sawyer S, Wellington M, et al. Improved Recovery of ATP and 2,3 DPG With Agitation During Incubation at 37 C in rejuvesol Solution Treated CPD/AS-1 RBC. Transfusion. 2013;53(Suppl):Abstract SP81.