Identification
- Summary
Plasma protein fraction (human) is a plasma protein solution used to treat coagulation factor deficiencies, reverse anticoagulant effects, and shock from a loss of plasma fluids, and is also used in plasma exchange procedures.
- Generic Name
- Plasma protein fraction (human)
- DrugBank Accession Number
- DB13968
- Background
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
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- Associated Therapies
- Contraindications & Blackbox Warnings
Avoid life-threatening adverse drug eventsImprove clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events & improve clinical decision support.- 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
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.Improve decision support & research outcomes with our structured adverse effects data.- 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
- 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
- No interactions found.
Products
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Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image 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 Octaplas Solution 11.5 g/200mL Intravenous Octapharma USA Inc 2013-07-18 Not applicable US Octaplasma Solution 14 g / 200 mL Intravenous Octapharma Pharmazeutika Produktionsges M B H 2012-05-31 Not applicable Canada 
Plasma Protein Fraction (human) Protenate Liquid 5 g / 100 mL Intravenous Hyland, Division Of Baxter Healthcare Corporation 1963-12-31 2003-07-31 Canada
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
- Affected organisms
- Humans
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. [Article]
- KELLEY MB, ROBERTS S: Metabolism of plasma proteins in vitro. J Biol Chem. 1956 Oct;222(2):555-64. [Article]
- FDA code of federal regulations [Link]
- Dailymed [Link]
- Dailymed [Link]
- Octapharma [Link]
- Octapharma monograph [Link]
- External Links
- 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 Coagulation Disorder / Hepatic dysfunction / Hepatic Surgery / Surgery, Cardiac 1 4 Completed Treatment Endothelial Dysfunction / Thoracic Aortic Aneurysm (TAA) 1 4 Withdrawn Treatment Postpartum Haemorrhage (PPH) 1 2 Active Not Recruiting Treatment Septic Shock 1 2 Recruiting Treatment Alzheimer's Disease (AD) 1 2 Recruiting Treatment Coronavirus Disease 2019 (COVID‑19) 1 1 Completed Treatment Comparison of Octaplas LG and Octaplas SD 1 Not Available Completed Not Available Factor VII Deficiency 1 Not Available Recruiting Supportive Care Coagulation; Intravascular / Electrolyte imbalance 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, solution Intravenous 57.5 mg/ml Solution Intravenous 11.5 g/200mL Solution Intravenous 57.5 mg/200ml Solution, concentrate Intravenous 70 mg Solution Intravenous 6 g/100ml Solution Intravenous 14 g / 200 mL Injection, solution Intravenous Liquid Intravenous 5 g / 100 mL Injection, solution Parenteral 57.5 mg/ml Solution Intravenous Injection Intravenous 5 g/100ml Injection, powder, lyophilized, for solution Intravenous 6 g Injection, solution Intravenous Solution Parenteral - 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 at January 17, 2018 21:46 / Updated at July 01, 2022 12:31