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
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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
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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
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
OctaplasSolution11.5 g/200mLIntravenousOctapharma USA Inc2013-07-18Not applicableUS flag
OctaplasSolution11.5 g/200mLIntravenousOctapharma USA Inc2013-07-18Not applicableUS flag
OctaplasSolution11.5 g/200mLIntravenousOctapharma USA Inc2013-07-18Not applicableUS flag
OctaplasSolution11.5 g/200mLIntravenousOctapharma USA Inc2013-07-18Not applicableUS flag
OctaplasmaSolutionIntravenousOctapharma Pharmazeutika Produktionsges M B H2012-05-31Not applicableCanada flag
Plasma Protein Fraction (human) ProtenateLiquidIntravenousHyland, Division Of Baxter Healthcare Corporation1963-12-312003-07-31Canada flag
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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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
  1. 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]
  2. KELLEY MB, ROBERTS S: Metabolism of plasma proteins in vitro. J Biol Chem. 1956 Oct;222(2):555-64. [PubMed:13367025]
  3. FDA code of federal regulations [Link]
  4. Dailymed [Link]
  5. Dailymed [Link]
  6. Octapharma [Link]
  7. Octapharma monograph [Link]
RxNav
33835
AHFS Codes
  • 16:00.00 — Blood Derivatives
  • 20:28.16 — Hemostatics
FDA label
Download (213 KB)
MSDS
Download (430 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedTreatmentAdverse Effects in the Therapeutic Use of Plasma Substitutes1
4CompletedTreatmentAortic Aneurysm, Thoracic / Endothelial Dysfunction1
4CompletedTreatmentCoagulation Disorders / Liver Dysfunction / Liver Surgery / Surgery, Cardiac1
4WithdrawnTreatmentPostpartum Haemorrhage (PPH)1
2Active Not RecruitingTreatmentShock, Septic1
1CompletedTreatmentComparison of Octaplas LG and Octaplas SD1
Not AvailableCompletedNot AvailableFactor VII Deficiency1
Not AvailableTerminatedNot AvailableCoagulation Disorders / Endstage Liver Disease1
Not AvailableTerminatedNot AvailableThrombotic Thrombocytopenic Purpura (TTP)1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, solutionIntravenous57.5 mg/ml
SolutionIntravenous11.5 g/200mL
Solution, concentrateIntravenous70 mg
SolutionIntravenous
LiquidIntravenous
Injection, solutionParenteral57.5 mg/ml
Injection, powder, lyophilized, for solutionIntravenous6 g
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
PropertyValueSource
boiling point (°C)>100 ºC'MSDS'
water solubilitySoluble'MSDS'

Drug created on January 17, 2018 14:46 / Updated on October 19, 2020 07:46

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