Brand names: Albuminar, AlbuRx, Albutein, Buminate, Flexbumin, Plasbumin
Drug class: Blood Derivatives
ATC class: B05AA01
VA class: BL500
CAS number: 9048-46-8

Medically reviewed by Drugs.com on Sep 18, 2023. Written by ASHP.

Introduction

A protein colloid; a sterile solution of serum albumin prepared by fractionating pooled plasma from healthy human donors.

Uses for Albumin Human

Hypovolemia

Used for plasma volume expansion and maintenance of cardiac output (fluid resuscitation) in the emergency treatment of hypovolemia (with or without shock) when urgent restoration of blood volume is indicated.

Goal of fluid resuscitation is to restore intravascular volume and preserve organ perfusion while minimizing complications of fluid overload (e.g., pulmonary edema).

Albumin human, a protein colloid, is one of several options that can be used to restore effective circulating volume; other options include nonprotein colloids (e.g., hetastarch, dextran) and large volume crystalloids (e.g., lactated Ringer's, various sodium chloride-containing solutions).

Beneficial effect of albumin human for fluid resuscitation is thought to result principally from its contribution to colloid osmotic pressure (i.e., oncotic pressure).

Albumin human should not be considered a substitute for blood or blood components when oxygen-carrying capacity is reduced and/or when replenishment of clotting factors or platelets is necessary. Transfusion with whole blood or packed RBCs is required in patients with active hemorrhage and/or substantial anemia.

Controversy exists regarding optimum choice of fluid (i.e., crystalloids, albumin human, nonprotein colloids) for fluid resuscitation. Protocols used, including type of replacement fluid, vary widely among health-care facilities and may depend on geographic area (e.g., country).

Theoretical advantages of colloids include greater retention in the intravascular space, more effective and rapid plasma volume expansion, and reduced risk of pulmonary edema. However, colloids generally have not been shown to be more effective than crystalloids, and costs associated with colloids are substantially higher than those associated with crystalloids.

Based on current evidence, albumin human appears to offer no survival advantage over crystalloids for fluid resuscitation; possibility of a modest benefit or harm cannot be excluded. Additional studies needed to determine role of albumin human in selected patient populations.

Hemorrhagic Shock

Used for fluid resuscitation in patients with hemorrhagic shock.

Guidelines on use of albumin, nonprotein colloids, and crystalloids issued in 2000 by the US University Health System Consortium (UHC) state that crystalloids are preferred for initial fluid resuscitation in adults with hemorrhagic shock. Nonprotein colloids may be considered when crystalloids (4 L) fail to produce an adequate response within 2 hours; albumin human 5% solution may be considered if nonprotein colloids are contraindicated.

Initiate transfusion with whole blood or packed RBCs as soon as possible when there is active hemorrhage and/or substantial anemia.

Nonhemorrhagic (Maldistributive) Shock

Has been used for fluid resuscitation in patients with nonhemorrhagic (maldistributive) shock, including septic shock.

UHC guidelines state that crystalloids should be considered first-line therapy in adults with nonhemorrhagic (maldistributive) shock and that nonprotein colloids and albumin human should be used with caution in those with systemic sepsis. In the presence of capillary leak with pulmonary and/or severe peripheral edema, use of up to 4 L of crystalloid solution is appropriate before using colloids. If albumin human is used for acute management of nonhemorrhagic shock, consider possibility of a potentially detrimental effect on edema in patients with increased capillary permeability or capillary leak.

Other experts state that either crystalloids or colloids can be used for fluid resuscitation in patients with septic shock. Although there is some evidence that adult or pediatric patients with severe infection and shock who receive albumin human have lower mortality compared with those who receive crystalloids, prospective, randomized studies are needed to clearly identify which type of fluid is superior for fluid resuscitation in patients with septic shock.

Thermal Injury

Has been used for fluid resuscitation in burn patients.

Fluid resuscitation is an essential component of burn therapy, but optimum regimen of crystalloids, colloids, electrolytes, and fluid not clearly established.

Crystalloids generally recommended for initial fluid resuscitation during first 24 hours following thermal injury. Beyond 24 hours, colloids may be used in conjunction with crystalloids to prevent hemoconcentration, combat electrolyte imbalances, and counteract protein deficits. To avoid complications of over-resuscitation (“fluid creep”), such as abdominal compartment syndrome and ARDS, use minimal amount of fluid necessary to maintain adequate organ perfusion.

UHC guidelines recommend crystalloids for initial fluid resuscitation in adults with thermal injury, but state that nonprotein colloids may be added if burns extend over >30% of body surface area and if >4 L of crystalloid has been administered 18–26 hours following initial injury; albumin human may be considered if nonprotein colloids are contraindicated.

Guidelines issued by the American Burn Association state that the addition of colloids to burn resuscitation protocols may be beneficial in terms of decreasing total fluid volume requirements, but randomized, controlled trials are needed to clearly establish other benefits.

In pediatric burn patients, albumin human does not appear to decrease morbidity and mortality and, depending on the preparation used, may result in aluminum accumulation in infants. (See Aluminum Content under Cautions.)

Nephrosis and Nephrotic Syndrome

Used as an adjunct to diuretic therapy to treat edema in patients with acute nephrosis refractory to cyclophosphamide and steroid therapy.

Cardinal features of nephrotic syndrome include albuminuria, hypoalbuminemia, and edema. Decreased hepatic production and increased renal catabolism are responsible for hypoalbuminemia and renal sodium retention is responsible for edema.

Principal goal of therapy is treatment of the underlying cause. Diuretic therapy is treatment of choice for symptomatic management.

UHC guidelines recommend short-term adjunctive use of albumin human with diuretics in adults with nephrotic syndrome who have acute, severe peripheral and/or pulmonary edema unresponsive to diuretics alone; consider possibility of potentially detrimental effect on edema.

Albumin human has no role in management of chronic nephrosis; parenteral albumin is rapidly excreted renally with no relief of chronic edema and no effect on the underlying renal lesion.

Hemodialysis

Has been used as an adjunct to hemodialysis in long-term hemodialysis patients with oncotic or volume deficits or in those experiencing shock or hypotension who cannot tolerate substantial volumes of sodium chloride solution.

Intradialytic hypotension, a complication of hemodialysis (especially in long-term hemodialysis patients), usually is managed by volume expansion through the use of crystalloids (e.g., 0.9% sodium chloride solutions, hypertonic sodium chloride solutions), nonprotein colloids, or albumin human.

Although some experts recommend colloids for dialysis-related hypotension and maintenance of hemodynamics in chronic dialysis patients, others state that 0.9% sodium chloride solution should be considered first-line therapy for treatment of intradialytic hypotension in maintenance hemodialysis patients.

UHC guidelines state that albumin human should not be used for intradialytic blood pressure support. If hemodialysis patients experience shock symptoms, crystalloids should be used for initial fluid resuscitation; nonprotein colloids may be considered if crystalloids (4 L) fail to produce an adequate response within 2 hours; albumin human 5% solution may be used if nonprotein colloids are contraindicated.

Cirrhotic Ascites and Paracentesis

Used to prevent central volume depletion following paracentesis in adults with cirrhosis who require removal of large volumes of ascitic fluid.

Diet modification (e.g., sodium restricted to 2 g daily) combined with oral diuretic therapy is first-line therapy for cirrhosis and ascites.

If tense ascites is present in new-onset disease, an initial large-volume paracentesis may be necessary in addition to sodium restriction and oral diuretics. In those with refractory ascites (fluid overload unresponsive to sodium restriction and high-dose oral diuretic therapy or that recurs rapidly after paracentesis), serial therapeutic paracentesis may be indicated to control ascites.

A single paracentesis involving removal of ≤4–5 L of fluid usually can be performed safely without postparacentesis colloid support; when larger volumes (>5 L) are removed, use of albumin human may be considered and usually is recommended to decrease risk of postparacentesis circulatory dysfunction and maintain effective arterial blood volume.

Although albumin human has been used alone (without large-volume paracentesis) in patients with cirrhosis in an attempt to control or prevent recurrence of ascites, guidelines from the American Association for the Study of Liver Diseases (AASLD) and UHC state that such use is notrecommended.

UHC guidelines state that albumin human should notbe used for treatment of noncirrhotic postsinusoidal portal hypertension^{† [off-label]}.

Despite the presence of hypoalbuminemia, albumin human has no role in the management of chronic cirrhosis^{† [off-label]}.

Hepatorenal Syndrome

Has been used in conjunction with vasoconstrictors for treatment of type I hepatorenal syndrome^{† [off-label]} in patients with cirrhosis.

Type I hepatorenal syndrome is characterized by acute, rapidly progressing renal failure caused by intrarenal vasoconstriction and usually requires liver transplantation if not reversed.

Although additional study is needed, AASLD and other experts state that a regimen of albumin human used in conjunction with vasoconstrictors (e.g., terlipressin [not commercially available in the US], octreotide and midodrine, norepinephrine) should be considered in the treatment of type I hepatorenal syndrome^{† [off-label]}.

Data are limited regarding use of albumin human alone or in conjunction with vasoconstrictors in the management of type II hepatorenal syndrome^{† [off-label]} (characterized by moderate and slowly progressive renal failure and typically associated with refractory ascites); additional study is needed to determine if albumin human has a role in this form of the disease.

Spontaneous Bacterial Peritonitis

Has been used for volume expansion as an adjunct to anti-infectives in the treatment of spontaneous bacterial peritonitis^† in patients with cirrhosis and ascites.

Spontaneous bacterial peritonitis is a complication that can occur in patients with cirrhosis and ascites, develops without a contiguous source of infection (e.g., intestinal perforation, intra-abdominal abscess), requires prompt empiric anti-infective therapy, and may result in potentially fatal, progressive renal impairment and/or hepatorenal syndrome. Although there is some evidence that adjunctive use of albumin human for volume expansion in addition to appropriate anti-infective treatment may decrease risk of renal impairment and death, such use is controversial and additional study is needed.

AASLD recommends that albumin human be used in addition to appropriate anti-infective treatment (e.g., cefotaxime) in patients who have ascitic fluid polymorphonuclear (PMN) counts ≥250 cells/mm³ and also have S _cr >1 mg/dL, BUN >30 mg/dL, or total bilirubin >4 mg/dL.

Acute Liver Failure

Has been used in patients with acute liver failure.

May serve dual purpose of supporting plasma colloid osmotic pressure as well as binding excess plasma bilirubin in the uncommon situation of rapid loss of liver function, with or without coma.

Individualize use in patients with acute liver failure. When fluid resuscitation is indicated, some experts recommend use of colloids (e.g., albumin human) instead of crystalloids.

Hepatic Resection

Has been used for postoperative fluid support in patients undergoing hepatic resection^†. Surgical liver resection results in substantial blood loss and, depending on preoperative functional status of the liver, decreased albumin production capacity.

UHC guidelines state that crystalloids are first-line therapy for maintenance of effective circulating volume following hepatic resection in adults; if crystalloids have no effect and anemia and/or coagulopathy are present, consider use of packed RBCs and fresh frozen plasma before use of albumin human.

UHC guidelines state that albumin human is appropriate to maintain effective circulation volume following major (>40%) hepatic resection in adults and also is indicated if clinically important edema develops secondary to use of crystalloids.

Hypoproteinemia

Has been used in management of severe hypoalbuminemia (with or without edema) in an attempt to restore serum albumin concentrations to within normal range. However, in the absence of clinically important hypovolemia, should not be used to correct temporary protein deficits resulting from redistribution of albumin.

Hypoproteinemia (hypoalbuminemia) can occur in association with various clinical conditions (e.g., surgery, sepsis, chronic liver failure, chronic renal impairment) and is a result of inadequate production, increased catabolism, redistribution, and/or excessive loss of albumin.

Principal goal of therapy is treatment of the underlying cause; albumin human may be used to provide symptomatic relief and prevent acute complications.

May relieve edema associated with hypoproteinemia by increasing colloid osmotic pressure and producing diuresis. However, there is potential risk of fluid overload if administered to normovolemic patients with hypoproteinemia.

Not recommended for use in severe hypoalbuminemia in the absence of hypovolemia simply to increase serum albumin concentrations to normal; identify and treat cause of the underlying hypoalbuminemia instead.

Should not be used for treatment of hypoproteinemia associated with chronic cirrhosis, chronic nephrosis, malabsorption, protein-losing enteropathies, pancreatic insufficiency, or malnutrition, unless a concomitant indication warrants use.

Has been used to treat neonatal hypoalbuminemia^†, but data are insufficient to determine whether routine use of albumin human reduces mortality or morbidity in preterm neonates with hypoalbuminemia.

Nutritional Support

Not recommended for use as a supplemental caloric protein source in nutritional support^†.

Oral, enteral, and/or parenteral nutrition with amino acids and treatment of underlying disorders generally restore plasma protein concentrations more effectively than albumin human.

Albumin human may be beneficial for severe diarrhea (>2 L daily) associated with enteral feeding intolerance^† when serum albumin concentration is <2 g/dL or if diarrhea occurs despite a trial of short-peptide and elemental formulas and other causes of diarrhea have been excluded.

Neonatal Hyperbilirubinemia

Adjunct to exchange transfusions in the treatment of neonatal hyperbilirubinemia, including hemolytic disease of the newborn (erythroblastosis fetalis).

Because of its ability to bind unconjugated bilirubin, albumin human may decrease risk of kernicterus in infants with hyperbilirubinemia.

Has been administered prior to exchange transfusion (as a primer) or during the procedure (as a substitute for a portion of the blood). Because there is some evidence that administration prior to exchange transfusion is less efficient in bilirubin removal and may increase the risk of volume overload, UHC guidelines recommend administration during the procedure if albumin human is used as an adjunct to exchange transfusion.

Use caution in hypervolemic infants. (See Hypervolemia/Hemodilution under Cautions.)

Not indicated when neonatal hyperbilirubinemia is treated using phototherapy without exchange transfusions.

Crystalloids and nonprotein colloids do not share the bilirubin-binding properties of albumin human and should not be considered alternatives for adjunctive treatment of neonatal hyperbilirubinemia.

Ovarian Hyperstimulation

Used as a plasma expander for fluid management in women with severe ovarian hyperstimulation syndrome (OHSS). Albumin human 20 or 25% solutions have been recommended in the treatment of severe OHSS if 0.9% sodium chloride solutions fail to achieve or maintain hemodynamic stability and adequate urine output.

Has been investigated for prevention of severe OHSS in high-risk women undergoing ovulation induction^†. Additional study needed to more fully evaluate benefits and risks for prevention of OHSS. Although there is some evidence that administration of albumin human 20 or 25% solution immediately before or after oocyte retrieval can reduce the risk of severe OHSS in high-risk women (i.e., <35 years of age, multifollicular development, high serum estradiol concentrations, nonobesity, polycystic ovary disease), other studies failed to confirm such benefits.

Acute Respiratory Distress Syndrome and Acute Lung Injury

Has been used in conjunction with a diuretic in the management of ARDS.

Use in ARDS is controversial because of the risk of aggravating interstitial fluid accumulation and other possible detrimental pulmonary effects. Although uncertainty exists regarding the precise indication in patients with ARDS, some manufacturers state that albumin human may have a therapeutic effect if used in conjunction with a diuretic in patients with pulmonary overload accompanied by hypoalbuminemia.

Has been used in conjunction with furosemide in the management of hypoproteinemic patients with acute lung injury^† (ALI) and has resulted in improved oxygenation and hemodynamic stability in some patients. Some experts state that conservative fluid management or restriction is appropriate for most patients with hemodynamically stable ALI/ARDS, but a regimen of colloids and diuretics may be considered in those with hypo-oncotic ALI/ARDS.

Sequestration of Protein Rich Fluids

Has been used for volume and oncotic replacement in conditions associated with sequestration of protein rich fluid (third-spacing) (e.g., acute peritonitis, pancreatitis, mediastinitis, extensive cellulitis).

Has been used as an adjunct to anti-infectives in the treatment of spontaneous bacterial peritonitis^† in patients with cirrhosis and ascites. (See Spontaneous Bacterial Peritonitis under Uses.)

May be useful in early treatment of shock associated with acute hemorrhagic pancreatitis or peritonitis.

UHC guidelines state that albumin human is not recommended in the treatment of acute or chronic pancreatitis.

Cardiac Surgery

Has been used as a pump prime for preoperative dilution of blood prior to cardiopulmonary bypass procedures, usually in conjunction with a crystalloid.

UHC guidelines state that crystalloids alone are preferred for priming cardiopulmonary bypass pumps in adults, although use of nonprotein colloids in addition to crystalloids may be preferred when it is extremely important to avoid pulmonary shunting.

Has been used in cardiac surgery patients to restore fluid balance during surgery and in the postoperative period; however, there are no data establishing clear benefit over crystalloids alone. For postoperative volume expansion after cardiac surgery in adults, UHC guidelines state that crystalloids are preferred, followed in descending order of preference by nonprotein colloids and then albumin human.

Neurosurgery and Cerebral Injury

Has been used for hemodilution to maintain or improve cerebral perfusion in the treatment of subarachnoid hemorrhage^†, acute ischemic stroke^†, traumatic brain injury^†, and in other neurosurgical patients^†.

Various fluid protocols have been used in an attempt to prevent secondary ischemia after subarachnoid hemorrhage, severe ischemic stroke, or severe traumatic brain injury; improved clinical outcomes reported in some patients. However, there is no clear evidence to date from adequately controlled, randomized studies that hemodilution decreases mortality or improves functional outcome in survivors of acute ischemic stroke.

UHC guidelines state that crystalloids are preferred for maintenance of cerebral perfusion pressure in the treatment of cerebral vasospasm associated with subarachnoid hemorrhage, cerebral ischemia, or head trauma in adults, but albumin human 25% solution should be used if cerebral edema is a concern. Patients with elevated hematocrits should receive crystalloids first to increase intravascular volume, creating a state of hypervolemia and hemodilution; those with hematocrits <30% should receive packed RBCs to increase intravascular volume and maintain cerebral perfusion pressure. If volume therapy alone is inadequate to maintain cerebral perfusion pressure, vasopressor therapy may be necessary.

Liver or Kidney Transplantation

Has been used to control ascites and severe pulmonary and peripheral edema in liver transplant recipients^†. Because of excessive blood loss, volume expanders such as crystalloids, blood products, nonprotein colloids, and albumin human may be required intraoperatively during liver transplantation.

UHC guidelines state that albumin human may be used in adult liver transplant recipients when serum albumin is <2.5 g/dL, pulmonary capillary wedge pressure is <12 mm Hg, and hematocrit is >30%.

Has been used intraoperatively in conjunction with crystalloids for volume expansion in kidney transplant patients. However, there is no conclusive evidence from controlled, randomized studies that albumin human given during and/or after renal transplant surgery improves outcome.

Plasmapheresis

Used in conjunction with large-volume plasma exchange as protein volume replacement in plasmapheresis^† procedures involving exchange of >20 mL of plasma/kg in one session or >20 mL/kg weekly in multiple sessions.

UHC guidelines state that nonprotein colloids and crystalloids may substitute for some of the albumin human in therapeutic plasmapheresis^† procedures and should be considered cost-effective exchange media.

Some evidence indicates that nonprotein colloids (e.g., hetastarch 3%) are comparably effective and tolerated relative to albumin for small- or large-volume plasma exchange.

Erythrocyte Resuspension

Has been used to resuspend large volumes of previously frozen or washed RBCs prior to administration or during certain types of exchange transfusion to provide sufficient volume and/or avoid excessive hypoproteinemia during the transfusion.

Albumin Human Dosage and Administration

Administration

Administer by IV infusion.

Concentration administered depends on fluid and protein requirements of the patient.

Albumin human 5% solution: Generally preferred for treatment of acute blood volume deficits in the absence of adequate or excessive hydration.

Albumin human 20 or 25% solutions: May be preferred in patients with oncotic deficits or in those with long standing hypovolemia and hypoalbuminemia that exists in the presence of adequate or excessive hydration. Also recommended when albumin human is used for its binding rather than oncotic properties (e.g., treatment of neonatal hyperbilirubinemia).

When used for treatment of hypovolemia, most effective in well-hydrated patients. If patient is dehydrated, albumin human 5% solution usually preferred; if albumin human 20 or 25% solution used in dehydrated patients, administer additional crystalloids or fluids.

Use immediately after vial or container is opened; discard if >4 hours have elapsed since container was first entered.

Consult manufacturers' prescribing information for specific directions regarding use of IV administration sets and filters. Some manufacturers state that adequate filtration is required; others state that filtration is not required.

IV Infusion

Dilution

Depending on indication, protein and fluid requirements, sodium restrictions, and availability, commercially available albumin human solutions can be administered undiluted or can be further diluted in a compatible IV solution (e.g., 0.9% sodium chloride, 5% dextrose). For solution and drug compatibility information, see Compatibility under Stability.

Whenever dilution of albumin human is necessary, the oncotic and osmotic properties as well as the tonicity of the resultant dilution must be considered.

Substantially hypotonic solutions when admixed with erythrocytes result in hemolysis. Such hemolysis occurs when erythrocytes are admixed in vitro with albumin human solutions containing less than 90 mEq of sodium per L; the sodium concentration not the suspending medium (albumin) or cell concentration determines the hemolytic risk.

Because of risk of potentially life-threatening hemolysis and acute renal failure, do not dilute albumin human with sterile water since tonicity can be reduced substantially by such dilution. (See Oncotic, Osmotic, and Tonicity Considerations under Cautions.)

If necessary, albumin human 5% solutions may be prepared from albumin human 25% solutions by adding 1 volume of the 25% solution to 4 volumes of 0.9% sodium chloride or 5% dextrose. Since albumin human 25% solution diluted with 0.9% sodium chloride or 5% dextrose results in 5% dilutions that are approximately isotonic and iso-oncotic with citrated plasma, these diluents are preferred for such dilutions.

Do not use dilutions with substantially reduced tonicity as replacement fluids in plasmapheresis procedures or other situations where administration of large volumes and resultant replacement of a significant fraction of blood volume could result.

When sodium restriction is necessary, administer albumin human solutions either undiluted or diluted in sodium-free carbohydrate solution such as 5% dextrose. However, because administration of large volumes of albumin human 5% prepared by diluting 25% solutions with 5% dextrose could result in hyponatremia and potentially serious adverse effects (e.g., cerebral swelling), 0.9% sodium chloride is the preferred diluent when administration, particularly rapid administration, of large volumes is anticipated (e.g., during plasmapheresis or plasma exchange) and the fluid and electrolyte status of the patient permits.

Alternatively, more physiologic diluents (e.g., those closely resembling plasma) can be used to dilute albumin human for use in plasmapheresis or plasma exchange.

Rate of Administration

Individualize rate of IV infusion based on indication, concentration of albumin human solution used, and patient's clinical status and response. Consult manufacturers’ prescribing information for specific recommendations.

Albumin human 5% solution: When used for treatment of hypovolemic shock in patients with greatly reduced blood volume, a rapid rate of administration may be necessary initially to provide clinical improvement and restore normal blood volume. However, in patients with a history of cardiac or vascular disease, some manufacturers suggest a slow infusion rate (e.g., 5–10 mL/minute) to avoid too rapid a BP increase. In patients with normal or slightly low blood volume, some manufacturers suggest an infusion rate of 1–2 mL/minute.

Albumin human 20 or 25% solutions: When used for treatment of hypovolemic shock in patients with greatly reduced blood volume, a rapid rate of administration may be necessary initially to provide clinical improvement and restore normal blood volume. However, in patients with normal or slightly low blood volume, some manufacturers state that the IV infusion rate should not exceed 1 mL/minute since more rapid infusion rates may result in circulatory overload or pulmonary edema. Slower rate also is recommended in patients with hypertension. When albumin human 20 or 25% solution is used in hypoproteinemic patients with approximately normal blood volume, a maximum rate of 2 mL/minute (Plasbumin-20, Plasbumin-25) or 2–3 mL/minute (Albuminar-25) has been recommended.

Pediatric patients: Some manufacturers recommend that rate of administration be reduced to 25% of the usual adult rate.

Dosage

Dosage is variable; individualize based on specific indication, concentration of albumin human solution used, and patient's clinical status and response. Consult manufacturers' prescribing information for specific dosage recommendations.

Predetermined formulas for dosage calculation generally are avoided since they assume that the same dose is appropriate for all patients.

In the absence of acute hemorrhage, total daily albumin dosage should not exceed the theoretical amount present in total normal plasma volume (i.e., 2 g/kg body weight).

To assess response to therapy, monitor hemodynamic response (e.g., BP), degree of pulmonary congestion, and hematocrit. Measurement of serum protein usually not necessary, but may be useful to guide dosage selection in some cases of hypoproteinemia.

Pediatric Patients

General Dosage

IV

Some manufacturers suggest 25–50% of the usual adult dose, depending on child's weight and clinical condition.

For specific dosage recommendations, consult manufacturers' prescribing information.

Hypovolemia

IV

0.5–1 g/kg is recommended by some clinicians.

Albumin human 5% solution: Some manufacturers recommend initial dose of 0.5–1 g/kg or 2.5–12.5 g. Dose may be repeated after 15–30 minutes if response is inadequate.

Albumin human 20% solution: One manufacturer recommends initial dose of 0.5–1 g/kg or 2.5–12.5 g. Dose may be repeated after 15–30 minutes if response is inadequate.

Albumin human 25% solution: Some manufacturers recommend initial dose of 0.5–1 g/kg or 2.5–12.5 g. Dose may be repeated after 15–30 minutes if response is inadequate.

Hypoproteinemia

IV

0.5–1 g/kg given over 0.5–2 hours and repeated once every 1–2 days as needed is recommended by some clinicians.

Albumin human 20 or 25% solution: 25 g daily recommended by one manufacturer; larger amounts may be required in those with severe hypoproteinemia who continue to lose albumin.

Neonatal Hyperbilirubinemia

IV

Albumin human 20 or 25% solutions: 1 g/kg as an adjunct to exchange transfusions.

Has been given prior to exchange transfusion (as a primer) or during the procedure (as a substitute for a portion of the blood). (See Neonatal Hyperbilirubinemia under Uses.)

Adults

Hypovolemia

IV

For hypovolemic shock, some manufacturers recommend the following initial dose. Dose may repeated after 15–30 minutes if response is inadequate.

Albumin human 5% solution: 12.5–25 g (250–500 mL of a 5% solution).

Albumin human 20% solution: 25 g (125 mL of a 20% solution).

Albumin human 25% solution: 25–50 g (100–200 mL of a 25% solution).

Thermal Injury

Burns

IV

Optimum regimen of crystalloids, colloids, electrolytes, and fluid not clearly established. Duration of replacement therapy varies, depending on such factors as extent of protein loss from renal excretion, denuded skin areas, and decreased albumin production.

A suggested goal is to maintain plasma albumin concentration of 2–3 g/dL and plasma oncotic pressure of 20 mm Hg (equivalent to a total plasma protein concentration of 5.2 g/dL).

One manufacturer recommends use of large volumes of crystalloids initially to maintain plasma volume; after 24 hours, albumin human may be added. Initially, 25 g; adjust dosage thereafter to maintain a plasma protein concentration of 2.5 g/dL or serum protein concentration of 5.2 g/dL.

Kidney Disease

Acute Nephrosis

IV

Albumin human 20 or 25% solutions: 20–25 g once daily for 7–10 days recommended by some manufacturers (in conjunction with an appropriate diuretic).

Hemodialysis

IV

Albumin human 20 or 25% solutions: If used for treatment of volume or oncotic deficit in patients undergoing long-term dialysis or for treatment of shock or hypotension in these patients, some manufacturers state that usual dose is about 100 mL (initial dose should not be >100 mL). Carefully monitor for signs of circulatory overload.

Liver Disease

Cirrhotic Ascites and Paracentesis

IV

Usually 6–8 g of albumin for each liter of ascitic fluid removed.

A single paracentesis involving removal of ≤4–5 L of fluid usually can be performed safely without colloid support; use of albumin human may be considered when larger volumes (>5 L) are removed.

Hepatorenal Syndrome (Type I)†

IV

Optimum regimens not identified.

Some experts recommend 1 g/kg (up to 100 g) on day 1, followed by 20–40 g once daily. If a response is obtained, continue until S _cr <1.5 mg/dL. May discontinue if serum albumin >4.5 g/dL; discontinue if pulmonary edema is present.

Spontaneous Bacterial Peritonitis†

IV

Optimum regimens not identified (see Spontaneous Bacterial Peritonitis under Uses).

AASLD recommends that adults with ascitic PMN counts ≥250 cells/mm³ and clinical suspicion of spontaneous bacterial peritonitis who also have S _cr >1 mg/dL, BUN >30 mg/dL, or total bilirubin concentration >4 mg/dL receive 1.5 g/kg of albumin human within 6 hours of detection and 1 g/kg on day 3.

Hypoproteinemia

IV

Albumin human 5% solution: 50–75 g recommended by one manufacturer.

Albumin human 20 or 25% solutions: 50–75 g daily (e.g., 250–375 mL of a 20% solution or 200–300 mL of a 25% solution) is recommended by some manufacturers; larger amounts may be required in those with severe hypoproteinemia who continue to lose albumin. Some manufacturers recommend a maximum dosage of 2 g/kg daily.

Consider total body albumin deficit (including hidden extravascular albumin deficiency) when determining dosage necessary to reverse hypoalbuminemia. When using serum albumin concentrations to estimate protein deficit, calculate body albumin compartment based on 80–100 mL/kg to account for any hidden extravascular albumin deficits.

Ovarian Hyperstimulation Syndrome (OHSS)

Treatment of Severe OHSS

IV

Albumin human 20 or 25% solutions: One manufacturer recommends 50–100 g given by IV infusion over 4 hours every 4–12 hours as necessary.

Acute Respiratory Distress Syndrome

IV

Albumin human 20 or 25% solutions: For management of fluid overload in conjunction with a diuretic (see Acute Respiratory Distress Syndrome and Acute Lung Injury under Uses), one manufacturer recommends 25 g given by IV infusion over 30 minutes and repeated at 8-hour intervals for 3 days, if necessary.

Cardiac Surgery

Cardiopulmonary Bypass

IV

Optimum fluid regimen to ensure adequate blood volume during cardiopulmonary bypass unclear. (See Cardiac Surgery under Uses.)

Some manufacturers suggest that albumin human and crystalloid pump prime solution be adjusted to achieve plasma albumin concentration of 2.5 g/dL and hematocrit of 20%.

Erythrocyte Resuspension

IV

Albumin human 20 or 25% solutions: If used to resuspend RBCs during certain types of exchange transfusion or to resuspend large volumes of previously frozen or washed RBCs, some manufacturers recommend adding approximately 20–25 g of albumin per liter of isotonic suspended RBCs immediately prior to transfusion; greater amounts may be required in patients with preexisting hepatic impairment or hypoproteinemia.

Prescribing Limits

Pediatric Patients

IV

Hypovolemia or hypoproteinemia: maximum 2 g/kg daily recommended by some manufacturers.

Maximum 6 g/kg in 24 hours or 250 g in 48 hours recommended by some clinicians.

Adults

IV

Maximum 2 g/kg daily recommended by some manufacturers.

Cautions for Albumin Human

Contraindications

• Hypersensitivity to albumin, any ingredient in the formulation, or component of the container. (See Sensitivity Reactions under Cautions.)

• Severe anemia.

• Cardiac failure in the presence of normal or increased intravascular volume.

• Consider that certain individuals are at particular risk of circulatory overload, including those with stabilized chronic anemia, CHF, or renal insufficiency. (See Renal Impairment under Cautions.)

• Buminate 25%: Contraindicated in patients with chronic renal impairment because of risk of aluminum accumulation. (See Aluminum Content under Cautions.)

• Dilution with sterile water for injection contraindicated because of risk of potentially life-threatening hemolysis and acute renal failure. (See Oncotic, Osmotic, and Tonicity Considerations under Cautions.)

Warnings/Precautions

Warnings

Risk of Transmissible Agents in Plasma-derived Preparations

Because albumin human is prepared from pooled human plasma, it is a potential vehicle for transmission of human viruses (e.g., hepatitis viruses, HIV) and theoretically may carry a risk of transmitting the causative agent of Creutzfeldt-Jakob disease (CJD) or related agents such as variant CJD (vCJD).

Donor plasma screening and viral elimination/inactivation procedures (e.g., pasteurization) have reduced, but not entirely eliminated risk of transmission of infectious agents.

Risk of transmission of viral disease with plasma-derived albumin human is considered extremely remote. No causes of transmission of HBV, HCV, or HIV have been documented following use of commercially available albumin human. However, transmission of nonenveloped viruses, (e.g., hepatitis A virus [HAV] and parvovirus B19) has been documented following administration of plasma-derived coagulation factors.

There are no documented cases of CJD or vCJD transmitted through plasma-derived preparations (including plasma-derived albumin human); theoretical risk for transmission of CJD with commercially available albumin human is considered extremely remote. There have been 3 probable cases of vCJD acquired through transfusion of RBCs. For further information on CJD and vCJD precautions related to blood and blood products, consult the FDA guidance for industry on this topic ().

Transmission of West Nile Virus (WNV) through commercially available plasma-derived preparations is unlikely; WNV is an enveloped virus, like HCV, which is known to be inactivated by purification and viral elimination/inactivation procedures used in manufacture of these preparations. However, there is evidence that WNV can be transmitted in transplanted organs (e.g., heart, liver, kidney) and blood products (e.g., whole blood, packed RBCs, fresh frozen plasma). For further information on WNV precautions related to blood and blood products, consult the FDA guidance for industry on this topic ([Web]).

Because no purification method has been shown to be totally effective in removing the risk of viral infectivity from plasma-derived preparations and because new blood-borne viruses or other disease agents may emerge which may not be removed or inactivated by current manufacturing processes, discuss risks and benefits of albumin human with patient.

Report any infection believed to have been transmitted by albumin human to the manufacturer.

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity reactions reported, including anaphylaxis or anaphylactoid reactions, fever, chills, rash, urticaria, pruritus, angioneurotic edema, and erythema or flushing.

If an allergic or hypersensitivity reaction (e.g., anaphylaxis) occurs or is suspected, discontinue immediately and initiate appropriate therapy as indicated. Epinephrine should be readily available in case acute hypersensitivity occurs.

Latex Sensitivity

Some packaging components of certain albumin human preparations (e.g., Buminate 5%, Buminate 25%) may contain natural latex proteins. Take appropriate precautions if these preparations are administered to individuals with a history of latex sensitivity.

Some individuals may be hypersensitive to natural latex proteins; rarely, hypersensitivity reactions to natural latex proteins have been fatal.

General Precautions

Hypervolemia/Hemodilution

Hypervolemia may occur if dosage and IV infusion rate are not adjusted based on patient's volume status. Rapid IV infusion may cause vascular overload.

Use with caution in conditions where hypervolemia and its consequences or hemodilution could represent a special risk for the patient (e.g., decompensated cardiac insufficiency, hypertension, esophageal varices, pulmonary edema, hemorrhagic diathesis, severe anemia, renal and postrenal anuria).

Use with caution in patients with low cardiac reserve (e.g., cardiac disease) and in those who do not have albumin deficiency. Use with great caution in patients with chronic anemia, hypertension, renal insufficiency, or severe pulmonary infections.

Closely observe all patients (especially those with normal or increased circulatory volumes) for signs of increased venous pressure such as pulmonary edema.

At first clinical sign of possible cardiovascular overload (e.g., headache, dyspnea, increased BP, jugular venous distention, elevated central venous pressure, pulmonary edema), immediately discontinue albumin human infusion and reevaluate patient.

Hemodynamic Monitoring

Closely monitor hemodynamic performance; evaluate patient for evidence of cardiac, respiratory, or renal failure or increasing intracranial pressure.

Frequently monitor arterial BP and pulse rate, central venous pressure, pulmonary artery occlusion pressure, urine output, electrolytes, hemoglobin, and hematocrit.

In postoperative or injured patients, a rapid rise in BP following administration of albumin human may reveal bleeding points that were not apparent at lower BP. To prevent hemorrhage and shock, carefully observe such patients and treat appropriately.

Anemia and Coagulation Abnormalities

If hemorrhage occurred in patients receiving albumin human, relative anemia may be present and should be controlled by supplemental administration of compatible whole blood or RBCs.

If comparatively large volumes of fluid are being replaced with albumin human, monitor coagulation parameters and hematocrit; ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets, erythrocytes) when indicated.

Electrolyte Imbalance

Monitor electrolyte status; take appropriate steps to restore or maintain electrolyte balance.

Compared with albumin human 5% solution, albumin human 20 and 25% solutions are relatively low in electrolytes.

Sodium Content

All commercially available albumin human preparations contain 130–160 mEq of sodium per L.

Oncotic, Osmotic, and Tonicity Considerations

When dilution of albumin human is necessary (e.g., to prepare a 5% solution from a 25% solution), the oncotic and osmotic properties as well as the tonicity of the resultant dilution must be considered.

Hypotonic dilutions can cause life-threatening hemolysis and acute renal failure.

Several cases of hemolysis (e.g., during or after plasmapheresis) and at least one death probably related to hemolysis have been reported following administration of as little as 270 mL of an albumin human 5% solution that had been prepared extemporaneously by diluting a 25% solution with sterile water. Such dilutions are markedly hypotonic with respect to blood, with calculated resultant sodium concentrations of 26–32 mEq/L.

Because of risk of potentially life-threatening hemolysis and acute renal failure, albumin human must not be diluted with sterile water. (See Dilution under Dosage and Administration.)

Aluminum Content

Aluminum has been detected as a contaminant in albumin human solutions; aluminum accumulation and associated toxicity (e.g., hypercalcemia, osteodystrophy with associated fracturing osteomalacia, severe progressive encephalopathy) reported in some patients with renal failure receiving albumin human (e.g., via plasmapheresis procedures).

Consider possibility that aluminum could accumulate in patients with impaired renal function.

Aluminum concentrations in commercially available albumin human vary widely from brand to brand and lot to lot, and reportedly may range up to 323–1830 mcg/L.

Manufacturer states that Buminate 25% should not be used in patients with chronic renal impairment because of risk of aluminum accumulation.

Certain commercially available albumin human preparations are labeled as containing ≤200 mcg/L of aluminum (AlbuRx 5 or 25%, Albutein 5 or 25%, Plasbumin 5, 20, or 25% [low aluminum formulations]).

Albumin human preparations containing ≤200 mcg/L of aluminum may be preferred in patients at high risk for aluminum toxicity (e.g., neonates, premature infants, geriatric adults, dialysis patients and others with impaired renal function, patients receiving total parenteral nutrition, burn patients).

Specific Populations

Pregnancy

Category C.

Consider potential risks and benefits for the specific patient. Use in pregnant women or during labor and delivery only if clearly needed. One manufacturer states that there is no evidence for any contraindications specifically associated with reproduction, pregnancy, or the fetus.

Lactation

Not known whether distributed into milk. Use caution and only when clearly needed.

Pediatric Use

Manufacturers of Albuminar and Plasbumin state safety and efficacy not established in pediatric patients.

Manufacturers of Buminate and Flexbumin state specific pediatric safety studies have not been performed; safety has been demonstrated in children receiving dosage appropriate for child's body weight.

Some manufacturers state data regarding use in pediatric patients, including premature infants, are limited. Weigh benefits and risks and use in pediatric patients only when clearly needed.

Has been used as an adjunct to exchange transfusions in the treatment of neonatal hyperbilirubinemia, including hemolytic disease of the newborn (erythroblastosis fetalis). Not indicated when neonatal hyperbilirubinemia is treated using phototherapy without exchange transfusions. (See Neonatal Hyperbilirubinemia under Uses.) Use caution in hypervolemic infants.

Some clinicians state albumin human 25% is contraindicated in preterm infants because of risk of intraventricular hemorrhage.

Risk of aluminum accumulation and associated toxicity in premature neonates. A preparation with low aluminum may be preferred in neonates and premature infants. (See Aluminum Content under Cautions)

Geriatric Use

Insufficient experience in patients >65 years of age to determine whether geriatric patients respond differently than younger adults.

Renal Impairment

Increased risk of circulatory overload. Use caution in hemodialysis patients or other patients with renal impairment and closely observe for signs of circulatory overload.

Risk of aluminum accumulation and associated toxicity. (See Aluminum Content under Cautions)

Common Adverse Effects

Anaphylactoid reactions, fever, chills, rash, nausea, vomiting, tachycardia, hypotension.

Drug Interactions

Specific drug interaction studies not performed using albumin human.

Specific Drugs

Stability

Storage

Parenteral

Injection

Store in tight containers at temperature recommended by manufacturer or indicated on label. Protect from light.

Most commercially available albumin human 5, 20, or 25% solutions should be stored at ≤30°C.

Do not freeze; do not use solutions that have been frozen.

Do not use if solution appears turbid or contains sediment.

Use immediately after opening; do not use if >4 hours have elapsed since vial or container was first entered.

Compatibility

May be administered in conjunction with whole blood or plasma, or with dextrose, sodium lactate, or sodium chloride injections.

Do not mix with parenteral nutrient solutions, protein hydrolysates, amino acid solutions, or solutions containing alcohol since proteins may precipitate in the solutions. (See Dilution under Dosage and Administration.)

Parenteral

Solution CompatibilityHID

Drug Compatibility

Actions

• Albumin is an important factor in regulation of plasma volume and tissue fluid balance through its contribution to the colloid oncotic pressure of plasma.

• Albumin is a highly soluble globular protein with a relatively low molecular weight (66,500) and exerts 70–80% of the colloid oncotic pressure of normal plasma.

• IV administration of concentrated albumin human solution causes a shift of fluid from the interstitial spaces into the circulation and a slight increase in the concentration of plasma proteins.

• In the US, albumin human is commercially available as 5, 20, or 25% solutions; other concentrations (e.g., 4% solutions) are available in other countries.

• Albumin human 5% solution is iso-oncotic with normal human plasma and will expand circulating blood volume by an amount approximately equal to the volume infused.

• When administered IV in well-hydrated patients, each volume of albumin human 20 or 25% solution draws about 2.5 or 3.5 volumes, respectively, of additional fluid into the circulation within 15 minutes, reducing hemoconcentration and blood viscosity.

• In patients with reduced circulating blood volumes (e.g., from hemorrhage or loss of fluid through exudates or into extravascular spaces), hemodilution persists for many hours. In patients with normal blood volume, excess fluid and protein are lost from the circulation within a few hours.

• When used for treatment of hypovolemia, most effective in well-hydrated patients.

• Not considered and not used as an IV nutrition source.

• Binds and functions as a carrier of intermediate metabolites (including bilirubin), trace metals, some drugs, dyes, fatty acids, hormones, and enzymes, thus affecting the transport, inactivation, and/or exchange of tissue products.

Advice to Patients

• Advise patient and/or patient's caregiver of the benefits and risks of albumin human.

• Advise patient and/or patient's caregiver that albumin human is prepared from pooled human plasma. Improved donor screening and viral-inactivating procedures used in manufacture of plasma-derived preparations have reduced, but not entirely eliminated, risk of pathogen transmission. (See Risk of Transmissible Agents in Plasma-derived Preparations under Cautions.)

• Importance of reporting any infection believed to have been transmitted by albumin human.

• Importance of discontinuing immediately if allergic symptoms or other severe adverse reactions (e.g., rash, hives, itching, breathing difficulties, coughing, nausea, vomiting, decrease in BP, increased heart rate) occur.

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

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

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

Preparations

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

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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