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Plasma protein fraction (human)
Identification
- Name
- Plasma protein fraction (human)
- Accession Number
- DB13968
- Description
The plasma protein fraction human (PPFh) is defined as a sterile solution of proteins composed mainly of albumin and globulin derived from human plasma.1 It is already reviewed under the category of biologics by the FDA where the processing, required tests, requirements and labeling are incorporated. This biologic should come from recovered plasma from whole blood or prepared source plasma. the final product should not include any type of additives. The composition of PPFh should be 5% of protein from which 83% should consist of albumin and no more of 17% should be globulin. It is also stated that no more than 1% of the total protein should be gamma globulin.3
PPFh is a sterile, frozen solution of solvent/detergent treated human plasma.5 The proteins in PPFh are stabilized with sodium caprylate and acetyltryptophan and it contains some electrolytes such as sodium, potassium and chloride.4
- Type
- Biotech
- Groups
- Approved
- Biologic Classification
- Protein Based Therapies
Blood factors - Protein Chemical Formula
- Not Available
- Protein Average Weight
- Not Available
- Sequences
- Not Available
- Synonyms
- Human plasma protein
- Human plasma protein fraction
- Human plasma proteins
- Plasma protein fraction
- Plasma protein fraction human
- Plasma protein fraction,human
Pharmacology
- Indication
PPFh is used as a replacement therapy in patients with complex deficiencies of coagulation factors such as coagulopathy. It is also used as a substitution therapy in emergency cases of factor deficiencies, for rapid reversal of the effects of oral anticoagulants or in dangerous hemorrhages during fibrinolytic therapy. PPFh can be used in therapeutic plasma exchange procedures including thrombotic thrombocytopenic purpura.6
PPFh can be used in the treatment of shock where there is a predominant loss of plasma fluids and not red blood cells.4
- Associated Conditions
- Contraindications & Blackbox Warnings
Learn about our commercial Contraindications & Blackbox Warnings data.
Learn More- Pharmacodynamics
Preclinical studies were not performed as this product is exclusively human and any result in animals is not relevant. This factor creates the need for having very regulated manufacturing processes. From this control, the presence of two contaminants have been noticed (TNBP and Octoxynol). The administration of this two contaminants in rodents showed a very rapid elimination of TNBP with a terminal half-life of 20 min. TNBP was never found in urine and only traces were located in feces. In the case of octoxynol, it was not detected in plasma, urine or feces.7
In humans, the use of PPFh is been reported to consistently regularize the level of all blood factors. In clinical trials was also observed a complete stop of abnormal bleeding.7 The reported effect was sustained during 48 hours in the case of shock treatment.4
- Mechanism of action
PPFh acts by replacing the missing blood plasma factor in the patient. It is important to highlight that as a part of the manufacturing process, PPFh has to be completely virus inactivated.7
- Absorption
PPFh is administered always intravenously and thus, it is immediately available in the organism.7
- Volume of distribution
The registered volume of distribution is reported to be of approximately 25-50 ml/kg. This value depends on the studied factor.7
- Protein binding
This pharmacokinetic property is not relevant.
- Metabolism
The different proteins constituting PPFh are metabolized as the normal endogenous proteins. From this thought, the liver seems to be the most important organ for the metabolism of plasma proteins. It is also known that globulins are more rapidly metabolized than albumin. Albumin is mainly metabolized by oxidation and used for energetic purposes.2
- Route of elimination
The different proteins constituting PPFh are metabolized as the normal endogenous proteins. Under this thought, after the corresponding metabolism, the proteins that constitute PPFh can be eliminated via feces, urine or expiration.2
- Half-life
The registered clearance rate is reported to be in a range of 5-60 h. This value depends on the studied factor.7
- Clearance
The registered clearance rate is reported to be in a range of 0.6-7.9 ml.kg/h. This value depends on the studied factor.7
- Adverse Effects
Learn about our commercial Adverse Effects data.
Learn More- Toxicity
Overdosage of PPFh can result in hypervolemia, pulmonary edema and or cardiac failure.6 Studies regarding the mutagenic potential, effect in fertility and peri- and post-natal development, genotoxic potential and carcinogenic properties demonstrate that PPFh is an inactive product.7
- Affected organisms
- Humans
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.Not Available
- Food Interactions
- Not Available
Products
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Unlock Additional DataOctaplas Solution 11.5 g/200mL Intravenous Octapharma USA Inc 2013-07-18 Not applicable US 
Octaplas Solution 11.5 g/200mL Intravenous Octapharma USA Inc 2013-07-18 Not applicable US Octaplas Solution 11.5 g/200mL Intravenous Octapharma USA Inc 2013-07-18 Not applicable US Octaplas Solution 11.5 g/200mL Intravenous Octapharma USA Inc 2013-07-18 Not applicable US Octaplasma Solution Intravenous Octapharma Pharmazeutika Produktionsges M B H 2012-05-31 Not applicable Canada 
Plasma Protein Fraction (human) Protenate Liquid Intravenous Hyland, Division Of Baxter Healthcare Corporation 1963-12-31 2003-07-31 Canada Additional Data Available- Application NumberApplication Number
A unique ID assigned by the FDA when a product is submitted for approval by the labeller.
Learn more - Product CodeProduct Code
A governmentally-recognized ID which uniquely identifies the product within its regulatory market.
Learn more
Categories
- Drug Categories
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
Chemical Identifiers
- UNII
- 6D53G0FD0Z
- CAS number
- Not Available
References
- General References
- Hink JH Jr, Pappenhagen AR, Lundblad J, Johnson FF: Plasma protein fraction (human). Physical and clinical properties after storage for 7-8 years. Vox Sang. 1970 Jun;18(6):527-41. [PubMed:4104308]
- KELLEY MB, ROBERTS S: Metabolism of plasma proteins in vitro. J Biol Chem. 1956 Oct;222(2):555-64. [PubMed:13367025]
- FDA code of federal regulations [Link]
- Dailymed [Link]
- Dailymed [Link]
- Octapharma [Link]
- Octapharma monograph [Link]
- External Links
- AHFS Codes
- 16:00.00 — Blood Derivatives
- 20:28.16 — Hemostatics
- FDA label
- Download (213 KB)
- MSDS
- Download (430 KB)
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Completed Treatment Adverse Effects in the Therapeutic Use of Plasma Substitutes 1 4 Completed Treatment Aortic Aneurysm, Thoracic / Endothelial Dysfunction 1 4 Completed Treatment Coagulation Disorders / Liver Dysfunction / Liver Surgery / Surgery, Cardiac 1 4 Withdrawn Treatment Postpartum Haemorrhage (PPH) 1 2 Active Not Recruiting Treatment Shock, Septic 1 1 Completed Treatment Comparison of Octaplas LG and Octaplas SD 1 Not Available Completed Not Available Factor VII Deficiency 1 Not Available Terminated Not Available Coagulation Disorders / Endstage Liver Disease 1 Not Available Terminated Not Available Thrombotic Thrombocytopenic Purpura (TTP) 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Solution Intravenous 11.5 g/200mL Solution, concentrate Intravenous 70 mg Solution Intravenous Liquid Intravenous Injection, powder, lyophilized, for solution Intravenous 6 g - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
Property Value Source boiling point (°C) >100 ºC 'MSDS' water solubility Soluble 'MSDS'
Drug created on January 17, 2018 14:46 / Updated on September 25, 2020 15:13
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