Plasma protein fraction (human)

Identification

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

Associated Therapies

Blood Plasma Therapy

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

Name	Dosage	Strength	Route	Labeller	Marketing Start	Marketing End
Unlock Additional Data
Octaplas	Solution	11.5 g/200mL	Intravenous	Octapharma USA Inc	2013-07-18	Not applicable
Octaplas	Solution	11.5 g/200mL	Intravenous	Octapharma USA Inc	2013-07-18	Not applicable
Octaplas	Solution	11.5 g/200mL	Intravenous	Octapharma USA Inc	2013-07-18	Not applicable
Octaplas	Solution	11.5 g/200mL	Intravenous	Octapharma USA Inc	2013-07-18	Not applicable
Octaplasma	Solution		Intravenous	Octapharma Pharmazeutika Produktionsges M B H	2012-05-31	Not applicable
Plasma Protein Fraction (human) Protenate	Liquid		Intravenous	Hyland, Division Of Baxter Healthcare Corporation	1963-12-31	2003-07-31

Additional Data Available

Application Number

Available for Purchase

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

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Product Code

Available for Purchase

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

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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

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

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
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	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
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
Injection, solution	Intravenous	50 MG/ML
Liquid	Intravenous
Injection, solution	Parenteral	57.5 mg/ml
Solution	Intravenous	5 %
Injection, powder, lyophilized, for solution	Intravenous	6 g
Injection, solution	Intravenous	12.5 g/250ml
Solution	Parenteral	25 IU/ml

Prices