Rejuvesol Sodium Pyruvate, Inosine, Adenine, Sodium Phosphate, Dibasic, and Sodium Phosphate, Monobasic, Monohydrate .55 g/50mL; 1.34 g/50mL; .034 g/50mL; .73 g/50mL; .311 g/50mL Solution
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🧪 Inactive Ingredients / Excipients
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Rejuvesol .55 g/50mL; 1.34 g/50mL; .034 g/50mL; .73 g/50mL; .311 g/50mLthis 23731-7000-05 | Citra | 12 vials | — | — | FDA listed | — |
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⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 23731-7000-05 You're viewing this | 12 VIAL, SINGLE-USE in 1 CASE (23731-7000-5) / 50 mL in 1 VIAL, SINGLE-USE | 1997-02-26 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 ® (CP2D/AS-3, leukocyte reduced). The final concentration of ATP and 2,3-DPG achieved after rejuvenation will vary depending on the number of days of liquid storage at 1-6 °C prior to rejuvenation.
NOTE: For simplicity, RBC stored in CPD (non-leukocyte reduced), CPDA-1 (non-leukocyte reduced), CPD/ADSOL ® (CPD/AS-1 leukocyte reduced), CP2D/Nutricel ® (CP2D/AS-3, leukocyte reduced) are referred to hereafter as CPD, CPDA-1, CPD/AS-1, and CP2D/AS-3, respectively. Citra Labs, LLC, recommends that rejuvenation of RBC be performed after 14 days or longer of liquid storage. RBC (CPD, CPDA-1, CPD/AS-1, and CP2D/AS-3) 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 5,6 (See Warning and Contraindications ).
Rejuvenation of CPD or CPDA-1 RBC for Immediate use or for Cryopreservation RBC which have been collected and stored in CPD or CPDA-1 anticoagulant may be rejuvenated up to three days after the expiration date of the RBC, as long as storage at 1-6 °C is not interrupted. 3,4 After rejuvenation, RBC (CPD and CPDA-1) must be either washed and stored at 1-6 °C for up to 24 hours prior to transfusion or glycerolized and frozen at –80 °C (below –65 °C). Red Blood Cells Frozen Rejuvenated which were collected and stored in CPD or CPDA-1 may be stored frozen up to 10 years.
10 When RBC are rejuvenated after maximum liquid storage, i.e., CPD RBC at 24 days or CPDA-1 RBC at 38 days, the concentrations of 2,3-DPG and ATP increase typically to above normal. 1,3-5,6 CAUTION: RBC collected in CPD or CPDA-1 cannot be leukocyte reduced prior to rejuvenation. Rejuvenation of CPD/AS-1 RBC or CP2D/AS-3 Rejuvesol ® Solution has not been approved for the rejuvenation of RBC stored in any additive systems other than AS-1 or AS-3.
RBC stored in CPD/AS-1 or CP2D/AS-3 at 1-6 °C may be rejuvenated up to, but not exceeding, 42 days of storage as long as storage at 1-6 °C is not interrupted. Rejuvenated CPD/AS-1 RBC must be either washed and stored at 1-6 °C for up to 24 hours prior to transfusion or glycerolized and frozen at –80 °C (below –65 °C). Red Blood Cells Frozen Rejuvenated which were collected and stored in CPD/AS-1 may be stored for up to 3 years.
Rejuvenated CP2D/AS-3 RBC must be washed and stored at 1-6 °C for up to 24 hours prior to transfusion. Unlike rejuvenated CPD, CPDA-1, CPD/AS-1 RBC, and CP2D/AS-3, rejuvenated RBC collected and stored in any other anticoagulant/additive solution combination have not been approved to be immediately washed and transfused or for cryopreservation. Rejuvenation of CPD/AS-1 RBC for Cryopreservation When CPD/AS-1 RBC are rejuvenated at 42 days of liquid storage, frozen, deglycerolized, and stored for 24 hours, the concentration of 2,3-DPG and ATP increases to above normal.
In a limited study, the average 24 hour post-transfusion survival value of these cells was statistically higher than the reported 12 survival value of CPD/AS-1 red blood cell concentrates which are stored for 42 days prior to transfusion. The "dose" may be equivalent for a CPD/AS-1 RBC whether the unit is stored for 42 days prior to transfusion or stored for 42 days, rejuvenated, frozen, deglycerolized, and stored for 24 hours prior to transfusion. Unlike rejuvenated CPD/AS-1 RBC, rejuvenated RBC (CP2D/AS-3) has not been approved for cryopreservation.
Rejuvenation of CPD/AS-1 RBC or CP2D/AS-3 for Immediate Use When CPD/AS-1 RBC are rejuvenated at 42 days of liquid storage, washed, and stored for 24 hours, the concentration of ATP increases to day 0 values. For 2,3-DPG rejuvenation of RBCs stored in CPD/AS-1 for 42 days, the range of 2,3 DPG relative to day 0…
⚠️ Warnings ▾
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.
5,6 In patients with reduced arterial blood p0 2 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. 7 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. Based on the concentration of the residual inosine in rejuvenated RBC that are either washed or deglycerolized, the average washout of inosine was calculated to be > 97.4%.
A literature search for potential toxicity associated with the ingredients that comprise rejuvesol ® Solution, including potential metabolites, was conducted. 23 This report concludes that no theoretical contraindications would be associated with the transfusion of a single unit of unwashed , rejuvenated RBC that would contain amounts of pyruvate, inosine, adenine, phosphate, hypoxanthine, uric acid, and lactate that exceed reference values (excluding lactate) as these substances are naturally metabolized and/or are excreted.
23 The maximum number of properly processed rejuvenated RBC that can be transfused to a single recipient over their entire lifetime has not been determined.
🧬 Clinical Pharmacology ▾
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
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED PN 7012: 50 mL vial; 12 vials per case
📦 Storage and Handling ▾
STORAGE It is recommended that the product be stored at 15 - 25 °C (59 - 77 °F). Protect from freezing. Exposure to temperatures near or below freezing may produce a white precipitate in the solution; this precipitate will dissolve upon brief incubation at room temperature. Alternatively, the product may be warmed at 37 °C for up to one hour in a dry air incubator to dissolve the precipitate.
📋 Description ▾
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.