Plasma protein fraction (human)



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

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

Biologic Classification
Protein Based Therapies
Blood factors
Protein Chemical Formula
Not Available
Protein Average Weight
Not Available
Not Available
  • Human plasma protein
  • Human plasma protein fraction
  • Human plasma proteins
  • Plasma protein fraction
  • Plasma protein fraction human
  • Plasma protein fraction,human



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 Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Treatment ofAcquired coagulation factor deficiency••••••••••••
Used in combination to treatHypoproteinemiaCombination Product in combination with: Albumin human (DB00062)•••••••••••••••••••••• ••••••••
Used in combination to treatKwashiorkorCombination Product in combination with: Albumin human (DB00062)•••••••••••••••••••••• ••••••••
Treatment ofThrombocytopenic purpura••••••••••••
Used in combination for prophylaxis ofVaricella zoster virus infectionCombination Product in combination with: Human varicella-zoster immune globulin (DB11621)••••••••••••••••••••• •••••••••••••••
Associated Therapies
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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


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.


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


The registered clearance rate is reported to be in a range of 5-60 h. This value depends on the studied factor.7


The registered clearance rate is reported to be in a range of 0.6-7.9 This value depends on the studied factor.7

Adverse Effects
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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

Not Available
Pharmacogenomic Effects/ADRs
Not Available


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.


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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
OctaplasmaSolution14 g / 200 mLIntravenousOctapharma Pharmazeutika Produktionsges M B H2012-05-31Not applicableCanada flag


Drug Categories
Chemical TaxonomyProvided by Classyfire
Not Available
Organic Compounds
Super Class
Organic Acids
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Alternative Parents
Not Available
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available
Affected organisms
  • Humans

Chemical Identifiers

CAS number
Not Available


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. [Article]
  2. KELLEY MB, ROBERTS S: Metabolism of plasma proteins in vitro. J Biol Chem. 1956 Oct;222(2):555-64. [Article]
  3. FDA code of federal regulations [Link]
  4. Dailymed [Link]
  5. Dailymed [Link]
  6. Octapharma [Link]
  7. Octapharma monograph [Link]
FDA label
Download (213 KB)
Download (430 KB)

Clinical Trials

Clinical Trials


Not Available
Not Available
Dosage Forms
Injection, solutionIntravenous57.5 mg/ml
SolutionIntravenous11.5 g/200mL
SolutionIntravenous57.5 mg/200ml
Solution, concentrateIntravenous70 mg
SolutionIntravenous6 g/100ml
SolutionIntravenous14 g / 200 mL
Injection, solutionIntravenous
LiquidIntravenous5 g / 100 mL
Injection, solutionParenteral57.5 mg/ml
SolutionIntravenous5 %
InjectionIntravenous5 g/100ml
Injection, powder, lyophilized, for solutionIntravenous6 g
Injection, solutionIntravenous
Not Available
Not Available


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

Drug created at January 17, 2018 21:46 / Updated at June 18, 2024 20:06