Plasma Protein Fraction

Class: Blood Derivatives
ATC Class: B05AA
VA Class: BL500
CAS Number: 55963-80-9
Brands: Plasmanate

Introduction

Protein colloid; sterile solution of selected proteins prepared from pooled human plasma.104

Uses for Plasma Protein Fraction

Fluid Resuscitation (Shock)

Used for plasma volume expansion in the treatment of certain types of shock, including shock resulting from burns, crushing injuries, abdominal emergencies, or any other cause where there is a predominant loss of plasma fluids and not RBCs.104

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Adequate replacement for human plasma in the treatment of shock and suitable means of providing human proteins for their osmotic effect;104 however, albumin solutions may be preferable because they contain a greater percentage of albumin and, since they are more purified, are less likely to cause hypotensive reactions.a (See Hypotension under Cautions.)

Initial therapy in infants and small children for shock resulting from dehydration and infection.104

Emergency treatment of shock due to hemorrhage.104 Following the emergency phase of therapy, transfusions of whole blood or RBCs may be indicated, depending on the severity of the blood loss.104

Plasma Protein Fraction Dosage and Administration

Administration

IV Administration

Administer by IV infusion, preferably at a site at some distance from any site of infection or trauma.104

Swab the rubber stopper on vial with iodine tincture followed by a sterile antiseptic swab.104 Insert a 16-gauge needle or dispensing pin perpendicular to the stopper in the area delineated by a raised ring.104

Does not contain preservatives; discard any partially used vials.104

Do not mix with protein hydrolysates or solutions containing alcohol.104

To minimize administration errors, consult the manufacturer’s administration instructions for proper use.104

Rate of Administration

Adjust rate of infusion according to the clinical response of the patient and changes in BP.104

For hypovolemic shock in infants and young children: Infusion at a rate of up to 5–10 mL/minute has been suggested.a

As plasma volume approaches normal, do not exceed 5–8 mL/minute.a Rapid IV infusion (e.g., >10 mL/minute) may cause vascular overload.104 a (See Infusion Effects under Cautions.)

Dosage

Dosage depends on the patient’s condition and response to therapy.104

Pediatric Patients

Fluid Resuscitation (Shock)
Hypovolemic Shock
IV

Infants and young children: Initially, 6.6–33 mL/kg (0.33–1.65 g/kg of protein).a Subsequent dosage is determined by the patient’s condition.a

Adults

Fluid Resuscitation (Shock)
Hypovolemic Shock
IV

Usual minimum effective dosage: 250–500 mL (12.5–25 g of protein).104 Subsequent dosage is determined by the patient’s condition.a

Prescribing Limits

Adults

Fluid Resuscitation (Shock)
Hypovolemic Shock
IV

Do not exceed 5–8 mL/minute.a

Special Populations

No special population dosage recommendations at this time.104

Cautions for Plasma Protein Fraction

Contraindications

  • Cardiopulmonary bypass procedures.104 (See Hypotension under Cautions.)

  • Severe anemia.104

  • CHF.104

  • Increased blood volume.104

Warnings/Precautions

Warnings

Risk of Transmissible Agents in Plasma-derived Preparations

Potential vehicle for transmission of human viruses, including hepatitis virus, or other infectious agents.104

Despite screening for certain viruses (e.g., human immunodeficiency virus [HIV], hepatitis B virus [HBV], hepatitis C virus [HCV]) and a pasteurization procedure to reduce viral infectious potential associated with plasma protein fraction (PPF), a risk for transmission of infectious agents still remains.a

Transmission of nonenveloped viruses, including hepatitis HAV and parvovirus B19, has been documented following administration of plasma-derived coagulation factors.105

Report any suspected PPF-associated infections to the manufacturer.104

Risk of Creutzfeldt-Jakob Disease

May carry a risk of transmitting the causative agent of Creutzfeldt-Jacob disease (CJD) or variant CJD (vCJD).100 101 102 103 106 107

There have been 3 probable cases of vCJD acquired through transfusion of human RBCs,117 although, transmission via human plasma derivatives (including plasma-derived albumin) has not been documented to date.106 107 108

Risk of West Nile Virus

Evidence exists that West Nile Virus (WNV) can be transmitted in transplanted organs (e.g., heart, liver, kidney) and blood products (e.g., whole blood, packed RBCs, fresh frozen plasma).110 111 113 114 However, WNV transmission unlikely through commercially available plasma-derived preparations since WNV is an enveloped virus, like HCV, which is known to be inactivated by the heat and solvent/detergent viral inactivation procedures used in the manufacture of these preparations.111 112

For further information on WNV precautions related to blood and blood products, the FDA’s guidance for industry should be consulted ().111

General Precautions

Infusion Effects

Rapid infusion may cause vascular overload.a

Observe all patients (especially those with normal or increased circulatory volumes) for signs of hypervolemia, including dyspnea, fluid in the lungs, pulmonary edema, cardiac failure, or abnormal increases in BP or central venous pressure.a

Hypotension

Hypotension may occur, especially following rapid IV infusion (i.e., at rates >10 mL/minute) in patients undergoing surgery or in the pre- or postoperative period or during intra-arterial administration in patients on cardiopulmonary bypass.104 Monitor BP during administration; slow or stop the infusion if sudden hypotension occurs.104 BP may return to normal spontaneously following slowing or discontinuance of the infusion; vasopressors also may be used to correct hypotension.104

Sodium Content

Commercially available PPF contains approximately 145 mEq of sodium per liter.104

Trauma or Surgery Risk

Rapid rise in BP accompanying administration of PPF following injuries or surgery may reveal bleeding points that were not apparent at the lower BP; observe patient carefully to prevent hemorrhage and subsequent shock.a

Hematologic Effects

Does not contain coagulation factors and, therefore, cannot be used to correct coagulation disorders.104 Contains trace amounts of blood groups A and B isohemagglutins; however, these are at such low concentrations that use of PPF should have no effect on routine blood typing procedures.104

Specific Populations

Pregnancy

Category C.104

Pediatric Use

Manufacturer states that safety and efficacy not established in pediatric patients; however, protein colloid has been found to be very useful in infants and small children for initial treatment of shock resulting from dehydration and infection.104

Hepatic Impairment

Use with caution in patients with hepatic failure because of added protein, fluid, and sodium load.a

Renal Impairment

Use with caution in patients with renal failure because of added protein, fluid, and sodium load.a

Common Adverse Effects

Flushing,104 urticaria,104 nausea,104 headache,104 back pain.104

Plasma Protein Fraction Pharmacokinetics

Absorption

Duration

Following IV administration, increased blood volume may last up to 48 hours.104

Stability

Storage

Parenteral

Solution for Injection

Room temperature (not >30°C).104 Do not freeze.104

Do not use solutions that appear turbid.104

Do not start administration if >4 hours have elapsed since the container was first entered.104

Do not use solutions that have been frozen, since the container may crack and permit contamination of the contents.104

Actions

  • Pharmacologic properties of PPF are similar to those of its primary constituent, albumin.a

  • Replacement for human plasma in the treatment of shock.104

  • IV administration of PPF results in an increased blood volume.104

  • Causes a shift of fluid from the interstitial spaces into the circulation and a slight increase in the concentration of plasma protein.a

Advice to Patients

  • Potential risk of transmission of infectious agents (e.g., human viruses).104

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.104

  • Importance of women informing clinicians if they are or plan to become pregnant.104

  • Importance of informing patients of other important precautionary information.104 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Plasma Protein Fraction (Human)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for IV infusion

50 mg/mL

Plasmanate

Talecris

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions August 1, 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

100. Nightingale SL. Dear doctor letter regarding withdrawal of certain plasma products. Rockville, MD: Department of Health and Human Services. Public Health Service. Food and Drug Administration; 1995 Mar 29.

101. Department of Health and Human Services, Food and Drug Administration. Precautionary measures to further reduce the possible risk of transmission of Creutzfeldt-Jakob disease by blood and blood products. 1995 Aug 8. Memorandum.

102. Department of Health and Human Services, Food and Drug Administration. Precautionary measures to further reduce the possible risk of transmission of Creutzfeldt-Jakob disease by blood and blood products. 1995 Aug 8. (Supplemental recommendations to 1987 Nov 25 memorandum on deferral of donors who have received human pituitary-derived growth hormone.)

103. Vidor A. Dear customer letter regarding withdrawal of certain lots of Buminate 25%. Lakewood, NJ: Baxter Healthcare Corp; 1997 Mar 13.

104. Talecris. Plasmanate (plasma protein fraction [human] 5%) prescribing information. Research Triangle Park, NC; 2005 Jan.

105. Medical and Scientific Advisory Council (MASAC), National Hemophilia Foundation. MASAC recommendations concerning the treatment of hemophilia and other bleeding disorders (revised October 2005). MASAC recommendation #165. From National Hemophilia Foundation website ().

106. Medical and Scientific Advisory Council (MASAC), National Hemophilia Foundation. MASAC recommendations regarding the use of recombinant clotting factor products with respect to pathogen transmission (June 3, 2006). MASAC recommendation #169. From National Hemophilia Foundation website ().

107. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). Guidance for industry. Revised preventive measures to reduce the possible risk of transmission of Creutzfeldt-Jacob disease (CJD) and variant Creutzfeldt-Jacob disease (vCJD) by blood and blood products. January 2002. From FDA website ().

108. Ricketts MN, Cashman NR, Stratton EE et al. Is Creutzfeldt-Jacob disease transmitted in blood? Emerg Infectious Dis. 1997; 3:155-63.

109. Brown P, Will RG, Bradley R et al. Bovine spongiform encephalopathy and variant Creutzfeldt-Jakob disease: background, evolution, and current concerns. Emerg Infectious Dis. 2001; 7:6-16.

110. Centers for Disease Control and Prevention. West Nile virus activity—United States, October 10–16, 2002, and update on West Nile virus infections in recipients of blood transfusions. MMWR Morb Mortal Wkly Rep. 2002; 51:929-31. [PubMed 12403410]

111. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). Guidance for industry. Revised recommendations for the assessment of donor suitability and blood and blood product safety in cases of known or suspected West Nile virus infection. May 2003. From FDA website ().

112. National Hemophilia Foundation. West Nile virus fact sheet. From National Hemophilia Foundation website ().

113. Harrington T, Kuehnert MF, Kamel H et al. West Nile virus infection transmitted by blood transfusion. Transfusion. 2003; 43:1018-22. [PubMed 12869105]

114. Iwamoto M, Jernigan DB, Gausch A et al. Transmission of West Nile virus from an organ donor to four transplant recipients. N Engl J Med. 2003; 348:2196-203. [PubMed 12773646]

115. Chiron. New test developed to screen donated blood for West Nile virus by July 1 deadline. Press release. 2003 June 18.

116. Centers for Disease Control and Prevention. Questions and answers: blood transfusions and organ donations. From the CDC website ().

117. Hewitt PE, Llewelyn CA, Mackenzie J et al. Creutzfeldt-Jakob disease and blood transfusion: result of the UK transfusion medicine epidemiological review study. Vox Sang. 2006; 91:221-30. [PubMed 16958834]

a. AHFS Drug Information 2007. McEvoy GK, ed. Plasma protein fraction. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 1405–6.

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