Overview
Human serum albumin is the primary protein present in human blood plasma. The main function of albumin is to maintain the oncotic pressure of blood . It binds to water, cations (such as Ca2+, Na+ and K+), fatty acids, hormones, bilirubin, thyroxine (T4) and pharmaceuticals (including barbiturates). Albumin represents approximately 50% of the total protein content in healthy humans . Human albumin is a small globular protein (molecular weight: 66.5 kDa), consisting of a single chain of 585 amino acids organized in three repeated homolog domains (sites I, II, and III). Each domain comprises two separate sub-domains (A and B) . There are various preparations of albumin that are well established and widely available in the clinical setting , , . Also known as Albuminex 5% or 25%, one brand of human serum albumin is prepared from the pooled plasma of US donors in FDA-licensed facilities in the US . This is a biosimilar drug to existing human serum albumin and was approved for a biological license at both 5% and 25% concentrations by the FDA on June 21, 2018 .
Background
Human serum albumin is the primary protein present in human blood plasma. The main function of albumin is to maintain the oncotic pressure of blood . It binds to water, cations (such as Ca2+, Na+ and K+), fatty acids, hormones, bilirubin, thyroxine (T4) and pharmaceuticals (including barbiturates). Albumin represents approximately 50% of the total protein content in healthy humans . Human albumin is a small globular protein (molecular weight: 66.5 kDa), consisting of a single chain of 585 amino acids organized in three repeated homolog domains (sites I, II, and III). Each domain comprises two separate sub-domains (A and B) . There are various preparations of albumin that are well established and widely available in the clinical setting , , . Also known as Albuminex 5% or 25%, one brand of human serum albumin is prepared from the pooled plasma of US donors in FDA-licensed facilities in the US . This is a biosimilar drug to existing human serum albumin and was approved for a biological license at both 5% and 25% concentrations by the FDA on June 21, 2018 .
Indication
Albuminex solution is indicated for adults and children for hypovolemia, ascites, hypoalbuminemia including from burns, acute nephrosis, acute respiratory distress syndrome and cardipulmonary bypass .
Associated Conditions
- Acute Pyelonephritis(APN)
- Burns
- Hemolytic Disease of the Newborn
- Hypoalbuminemia
- Hypoproteinemia
- Hypovolaemia
- Shock, Hypovolemic
- Acute fulminant liver failure
- Central volume depletion
- Post-operative albumin loss
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2012/02/13 | Phase 4 | Terminated | Kedrion S.p.A. | ||
2011/05/25 | Phase 3 | Terminated | |||
2008/07/25 | Phase 3 | Completed | |||
2005/09/09 | Phase 2 | UNKNOWN | University Hospital, Angers | ||
2005/07/27 | Phase 3 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Human Albumin | 国药准字S10970074 | 生物制品 | 注射剂 | 11/6/2020 | |
Human Albumin | 国药准字S20043058 | 生物制品 | 注射剂 | 8/18/2020 | |
Human Albumin | 国药准字S20033029 | 生物制品 | 注射剂(注射液) | 2/5/2020 | |
Human Albumin | 国药准字S20093023 | 生物制品 | 注射剂 | 5/28/2020 | |
Human Albumin | 国药准字S10930019 | 生物制品 | 注射剂 | 7/30/2020 | |
Human Albumin | 国药准字S10940028 | 生物制品 | 注射剂(注射液) | 3/2/2020 | |
Human Albumin | 国药准字S10920009 | 生物制品 | 注射剂 | 7/30/2020 | |
Human Albumin | 国药准字S10970006 | 生物制品 | 注射剂 | 3/11/2020 | |
Human Albumin | 国药准字S10970068 | 生物制品 | 注射剂 | 2/12/2020 | |
Human Albumin | 国药准字SJ20210027 | 生物制品 | 注射剂 | 11/21/2021 |
PPB Drug Approvals
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TGA Drug Approvals
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