Albumin Human

Pronunciation

Class: Blood Derivatives
ATC Class: B05AA01
VA Class: BL500
CAS Number: 9048-46-8
Brands: Albuminar, AlbuRx, Albutein, Buminate, Flexbumin, Plasbumin

Introduction

A protein colloid; a sterile solution of serum albumin prepared by fractionating pooled plasma from healthy human donors.133 139 204 205 206 207 208 210 211 212 213 214 215 254 255 256

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.187 204 205 206 207 208 210 211 212 213 214 215 218 220 221 226 227 254 255 256 295 297 300 301 303 304

Goal of fluid resuscitation is to restore intravascular volume and preserve organ perfusion while minimizing complications of fluid overload (e.g., pulmonary edema).187 225

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).148 187 219 222 225 226 227 228 304 308

Beneficial effect of albumin human for fluid resuscitation is thought to result principally from its contribution to colloid osmotic pressure (i.e., oncotic pressure).148 210 211

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.134 170 187 Transfusion with whole blood or packed RBCs is required in patients with active hemorrhage and/or substantial anemia.204 205 207 208 210 211 214 215

Controversy exists regarding optimum choice of fluid (i.e., crystalloids, albumin human, nonprotein colloids) for fluid resuscitation.148 187 219 220 222 225 226 227 228 261 299 303 304 308 Protocols used, including type of replacement fluid, vary widely among health-care facilities148 187 219 220 222 225 226 227 228 261 303 304 308 and may depend on geographic area (e.g., country).304

Theoretical advantages of colloids include greater retention in the intravascular space, more effective and rapid plasma volume expansion, and reduced risk of pulmonary edema.187 211 214 220 225 226 227 228 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.148 187 219 220 222 225 226 228

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.187 218 219 222 225 Additional studies needed to determine role of albumin human in selected patient populations.218 219 222 224 225

Hemorrhagic Shock

Used for fluid resuscitation in patients with hemorrhagic shock.187 301

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.187 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.187

Initiate transfusion with whole blood or packed RBCs as soon as possible when there is active hemorrhage and/or substantial anemia.204 205 207 208 210 211 214 215 254 255 256

Nonhemorrhagic (Maldistributive) Shock

Has been used for fluid resuscitation in patients with nonhemorrhagic (maldistributive) shock, including septic shock.187 250 261 295 297 299 300

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.187 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.187 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.152 168 187

Other experts state that either crystalloids or colloids can be used for fluid resuscitation in patients with septic shock.250 251 261 295 297 300 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,222 261 297 299 300 prospective, randomized studies are needed to clearly identify which type of fluid is superior for fluid resuscitation in patients with septic shock.250 251 261 297 298 299 300

Thermal Injury

Has been used for fluid resuscitation in burn patients.187 218 302 305 306 307 309

Fluid resuscitation is an essential component of burn therapy,187 306 but optimum regimen of crystalloids, colloids, electrolytes, and fluid not clearly established.204 205 207 208 211 213 214 215 218 302 305 306 307 309

Crystalloids generally recommended for initial fluid resuscitation during first 24 hours following thermal injury.187 204 205 207 211 213 214 309 Beyond 24 hours, colloids may be used in conjunction with crystalloids to prevent hemoconcentration, combat electrolyte imbalances, and counteract protein deficits.204 205 207 208 210 211 213 214 215 309 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.305 306 307 309

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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.187

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.307

In pediatric burn patients, albumin human does not appear to decrease morbidity and mortality187 and, depending on the preparation used, may result in aluminum accumulation in infants.140 143 144 187 (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.187 204 205 206 208 214 215 245 255 256

Cardinal features of nephrotic syndrome include albuminuria, hypoalbuminemia, and edema.187 Decreased hepatic production and increased renal catabolism are responsible for hypoalbuminemia and renal sodium retention is responsible for edema.187

Principal goal of therapy is treatment of the underlying cause.187 Diuretic therapy is treatment of choice for symptomatic management.187

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;187 consider possibility of potentially detrimental effect on edema.152 168 187

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.134 204 205 213 214

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.204 205 206 212 214 261 265 266

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.261 265 266

Although some experts recommend colloids for dialysis-related hypotension and maintenance of hemodynamics in chronic dialysis patients,261 others state that 0.9% sodium chloride solution should be considered first-line therapy for treatment of intradialytic hypotension in maintenance hemodialysis patients.265

UHC guidelines state that albumin human should not be used for intradialytic blood pressure support.187 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.187

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.187 214 226 236 254 255 256 261 286 287 310

Diet modification (e.g., sodium restricted to 2 g daily) combined with oral diuretic therapy is first-line therapy for cirrhosis and ascites.187 236 286

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.236 286 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.236 287

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.187 236 261 264 286 287

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,187 236 285 236 guidelines from the American Association for the Study of Liver Diseases (AASLD) and UHC state that such use is notrecommended.187 236

UHC guidelines state that albumin human should notbe used for treatment of noncirrhotic postsinusoidal portal hypertension.187

Despite the presence of hypoalbuminemia, albumin human has no role in the management of chronic cirrhosis.21 134 148 204 205 206

Hepatorenal Syndrome

Has been used in conjunction with vasoconstrictors for treatment of type I hepatorenal syndrome in patients with cirrhosis.226 236 243 244 264 286 287 288 289 290 291 292 293 294

Type I hepatorenal syndrome is characterized by acute, rapidly progressing renal failure caused by intrarenal vasoconstriction and usually requires liver transplantation if not reversed.236 244 286 287 288 289 293 294

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.236 264 289 294

Data are limited regarding use of albumin human alone or in conjunction with vasoconstrictors in the management of type II hepatorenal syndrome (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.236 289 291 294

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.187 236 267 268 269 286 289 293

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.236 267 286 287 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,236 261 267 268 269 286 such use is controversial and additional study is needed.187 267 268 269 270 289

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.236

Acute Liver Failure

Has been used in patients with acute liver failure.205 206 213 296

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.204 205 213

Individualize use in patients with acute liver failure.206 When fluid resuscitation is indicated, some experts recommend use of colloids (e.g., albumin human) instead of crystalloids.296

Hepatic Resection

Has been used for postoperative fluid support in patients undergoing hepatic resection.187 Surgical liver resection results in substantial blood loss and, depending on preoperative functional status of the liver, decreased albumin production capacity.187

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.187

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.187

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.204 205 207 208 210 211 212 214 215 254 255 266 However, in the absence of clinically important hypovolemia, should not be used to correct temporary protein deficits resulting from redistribution of albumin.211 214 231

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.204 205 206 208 210 211 214 215 231

Principal goal of therapy is treatment of the underlying cause; albumin human may be used to provide symptomatic relief and prevent acute complications.204 205 206 207 208 210 211 212 214 215 226

May relieve edema associated with hypoproteinemia by increasing colloid osmotic pressure and producing diuresis.207 214 However, there is potential risk of fluid overload if administered to normovolemic patients with hypoproteinemia.231

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.147 152

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.204 205 211 213 214

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.231

Nutritional Support

Not recommended for use as a supplemental caloric protein source in nutritional support.21 148 187 204 205 206 208 210 211 213 214 215 226

Oral, enteral, and/or parenteral nutrition with amino acids and treatment of underlying disorders generally restore plasma protein concentrations more effectively than albumin human.208 210 215

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.134 148 177 187

Neonatal Hyperbilirubinemia

Adjunct to exchange transfusions in the treatment of neonatal hyperbilirubinemia, including hemolytic disease of the newborn (erythroblastosis fetalis).187 204 205 206 208 214 215 255 256

Because of its ability to bind unconjugated bilirubin, albumin human may decrease risk of kernicterus in infants with hyperbilirubinemia.187 204 205 206 208 214 215 255 256

Has been administered prior to exchange transfusion (as a primer) or during the procedure (as a substitute for a portion of the blood).187 204 205 208 214 215 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.187

Use caution in hypervolemic infants.204 205 214 (See Hypervolemia/Hemodilution under Cautions.)

Not indicated when neonatal hyperbilirubinemia is treated using phototherapy without exchange transfusions.134 187

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.187

Ovarian Hyperstimulation

Used as a plasma expander for fluid management in women with severe ovarian hyperstimulation syndrome (OHSS).255 256 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.238 255 256

Has been investigated for prevention of severe OHSS in high-risk women undergoing ovulation induction.187 232 237 238 239 240 241 242 258 259 260 Additional study needed to more fully evaluate benefits and risks for prevention of OHSS.187 232 260 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),232 237 238 239 240 241 242 other studies failed to confirm such benefits.258 259 260

Acute Respiratory Distress Syndrome and Acute Lung Injury

Has been used in conjunction with a diuretic in the management of ARDS.148 171 177 204 205 206 208 214 215 255 256

Use in ARDS is controversial because of the risk of aggravating interstitial fluid accumulation and other possible detrimental pulmonary effects.134 171 172 173 177 Although uncertainty exists regarding the precise indication in patients with ARDS,208 214 215 261 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.208 214 215

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.261 262 263 283 Some experts state that conservative fluid management or restriction is appropriate for most patients with hemodynamically stable ALI/ARDS,261 283 284 283 but a regimen of colloids and diuretics may be considered in those with hypo-oncotic ALI/ARDS.261 283

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).204 205 211 213 214

Has been used as an adjunct to anti-infectives in the treatment of spontaneous bacterial peritonitis in patients with cirrhosis and ascites.187 236 267 268 269 286 (See Spontaneous Bacterial Peritonitis under Uses.)

May be useful in early treatment of shock associated with acute hemorrhagic pancreatitis or peritonitis.211

UHC guidelines state that albumin human is not recommended in the treatment of acute or chronic pancreatitis.187

Cardiac Surgery

Has been used as a pump prime for preoperative dilution of blood prior to cardiopulmonary bypass procedures,187 204 205 206 208 210 212 213 214 281 282 usually in conjunction with a crystalloid.187 204 205 213 214 215 282

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.187

Has been used in cardiac surgery patients to restore fluid balance during surgery and in the postoperative period;187 208 210 215 281 however, there are no data establishing clear benefit over crystalloids alone.187 208 210 215 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.187

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.174 175 176 187 261 272 273 274 275 276 277 278 279 280

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.187 272 275 276 277 278 279 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.187 274

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.187 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.187 If volume therapy alone is inadequate to maintain cerebral perfusion pressure, vasopressor therapy may be necessary.187

Liver or Kidney Transplantation

Has been used to control ascites and severe pulmonary and peripheral edema in liver transplant recipients.187 Because of excessive blood loss, volume expanders such as crystalloids, blood products, nonprotein colloids, and albumin human may be required intraoperatively during liver transplantation.187

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%.187

Has been used intraoperatively in conjunction with crystalloids for volume expansion in kidney transplant patients.148 187 However, there is no conclusive evidence from controlled, randomized studies that albumin human given during and/or after renal transplant surgery improves outcome.148 187

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.148 187

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.187

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.134 178 179 180 181

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.204 205 214

Albumin Human Dosage and Administration

Administration

Administer by IV infusion.204 205 206 207 208 210 211 212 213 214 215 254 255 256

Concentration administered depends on fluid and protein requirements of the patient.21 204 205 208 210 213 215

Albumin human 5% solution: Generally preferred for treatment of acute blood volume deficits in the absence of adequate or excessive hydration.204 205 208 213 215

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.204 205 208 210 215 Also recommended when albumin human is used for its binding rather than oncotic properties (e.g., treatment of neonatal hyperbilirubinemia).204 205 206 208 211 212 214 215

When used for treatment of hypovolemia, most effective in well-hydrated patients.208 215 254 255 256 If patient is dehydrated, albumin human 5% solution usually preferred;204 205 208 213 215 if albumin human 20 or 25% solution used in dehydrated patients, administer additional crystalloids or fluids.204 205 206 207 208 214 215

Use immediately after vial or container is opened;254 255 256 discard if >4 hours have elapsed since container was first entered.204 205 206 207 208 210 211 212 213 214 215

Consult manufacturers' prescribing information for specific directions regarding use of IV administration sets and filters.204 205 206 207 208 210 211 212 213 214 215 254 255 256 Some manufacturers state that adequate filtration is required;206 208 210 212 215 others state that filtration is not required.254 255 256

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).37 124 125 126 127 128 129 130 131 132 133 134 135 136 137 184 204 205 206 207 208 214 215 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.37 124 125 126 127 128 129 130 131 132 133 134 135 136 137 184

Substantially hypotonic solutions when admixed with erythrocytes result in hemolysis.131 132 Such hemolysis occurs when erythrocytes are admixed in vitro with albumin human solutions containing less than 90 mEq of sodium per L;37 127 the sodium concentration not the suspending medium (albumin) or cell concentration determines the hemolytic risk.37 131 132

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.125 127 128 129 130 133 134 135 136 137 138 184 204 205 206 207 208 210 214 215 254 255 256 (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.208 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.133 136 137

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.125 126 127 128 129 130 133 136 137 138 184

When sodium restriction is necessary, administer albumin human solutions either undiluted or diluted in sodium-free carbohydrate solution such as 5% dextrose.133 184 204 205 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),136 137 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.136 137 184

Alternatively, more physiologic diluents (e.g., those closely resembling plasma) can be used to dilute albumin human for use in plasmapheresis or plasma exchange.136

Rate of Administration

Individualize rate of IV infusion based on indication, concentration of albumin human solution used, and patient's clinical status and response.204 205 206 207 208 210 211 212 213 214 215 254 255 256 Consult manufacturers’ prescribing information for specific recommendations.204 205 206 207 208 210 211 212 213 214 215 254 255 256

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.210 211 212 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.210 In patients with normal or slightly low blood volume, some manufacturers suggest an infusion rate of 1–2 mL/minute.211 212

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.206 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.206 207 208 215 Slower rate also is recommended in patients with hypertension.207 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)204 205 or 2–3 mL/minute (Albuminar-25) has been recommended.207

Pediatric patients: Some manufacturers recommend that rate of administration be reduced to 25% of the usual adult rate.206 212

Dosage

Dosage is variable; individualize based on specific indication, concentration of albumin human solution used, and patient's clinical status and response.204 205 206 207 208 210 211 212 213 214 215 254 255 256 Consult manufacturers' prescribing information for specific dosage recommendations.204 205 206 207 208 210 211 212 213 214 215

Predetermined formulas for dosage calculation generally are avoided since they assume that the same dose is appropriate for all patients.187

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).21 204 205 208 210 214 215 254 255 256

To assess response to therapy, monitor hemodynamic response (e.g., BP), degree of pulmonary congestion, and hematocrit.207 211 214 Measurement of serum protein usually not necessary, but may be useful to guide dosage selection in some cases of hypoproteinemia.214

Osmotic Equivalence of Commercially Available Albumin Human Injections for IV Infusion139

Albumin human injection for IV infusion

Osmotic equivalence

100 mL of 5% solution (5 g)

100 mL of normal human plasma

100 mL of 20% solution (20 g)

400 mL of normal human plasma

100 mL of 25% solution (25 g)

500 mL of normal human plasma

Pediatric Patients

General Dosage
IV

Some manufacturers suggest 25–50% of the usual adult dose, depending on child's weight and clinical condition.206 212

For specific dosage recommendations, consult manufacturers' prescribing information.206 208 210 211 212 213 215

Hypovolemia
IV

0.5–1 g/kg is recommended by some clinicians.311

Albumin human 5% solution: Some manufacturers recommend initial dose of 0.5–1 g/kg 213 254 254 or 2.5–12.5 g.254 Dose may be repeated after 15–30 minutes if response is inadequate.210 254

Albumin human 20% solution: One manufacturer recommends initial dose of 0.5–1 g/kg or 2.5–12.5 g.255 Dose may be repeated after 15–30 minutes if response is inadequate.255

Albumin human 25% solution: Some manufacturers recommend initial dose of 0.5–1 g/kg256 or 2.5–12.5 g.256 Dose may be repeated after 15–30 minutes if response is inadequate.208 215 255 256

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.311

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.204 205

Neonatal Hyperbilirubinemia
IV

Albumin human 20 or 25% solutions: 1 g/kg as an adjunct to exchange transfusions.204 205 206 208 214 215 255 256

Has been given prior to exchange transfusion (as a primer) or during the procedure (as a substitute for a portion of the blood).187 204 205 208 214 215 255 256 (See Neonatal Hyperbilirubinemia under Uses.)

Adults

Hypovolemia
IV

For hypovolemic shock, some manufacturers recommend the following initial dose.206 208 210 211 212 215 254 255 256 Dose may repeated after 15–30 minutes if response is inadequate.206 208 210 211 212 215 254 255 256

Albumin human 5% solution: 12.5–25 g (250–500 mL of a 5% solution).210 211 212 254

Albumin human 20% solution: 25 g (125 mL of a 20% solution).255

Albumin human 25% solution: 25–50 g (100–200 mL of a 25% solution).206 208 215 256

Thermal Injury
Burns
IV

Optimum regimen of crystalloids, colloids, electrolytes, and fluid not clearly established.204 205 207 208 211 213 214 215 218 302 305 306 307 309 Duration of replacement therapy varies, depending on such factors as extent of protein loss from renal excretion, denuded skin areas, and decreased albumin production.204 205 207 213 214

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).204 205 213 214

One manufacturer recommends use of large volumes of crystalloids initially to maintain plasma volume; after 24 hours, albumin human may be added.254 255 256 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.254 255 256

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).204 205 214 255 256

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 mL204 205 (initial dose should not be >100 mL).214 Carefully monitor for signs of circulatory overload.204 205 212 214

Liver Disease
Cirrhotic Ascites and Paracentesis
IV

Usually 6–8 g of albumin for each liter of ascitic fluid removed.187 236 254 255 256 286

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.187 236 261 264 286 287

Hepatorenal Syndrome (Type I)
IV

Optimum regimens not identified.226 236 243 244 264 286 287 288 289 290 291 292 293 294

Some experts recommend 1 g/kg (up to 100 g) on day 1, followed by 20–40 g once daily.289 293 294 If a response is obtained, continue until S cr <1.5 mg/dL.294 May discontinue if serum albumin >4.5 g/dL; discontinue if pulmonary edema is present.289

Spontaneous Bacterial Peritonitis
IV

Optimum regimens not identified (see Spontaneous Bacterial Peritonitis under Uses).236 267 268 269 286 289 293

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 3.236

Hypoproteinemia
IV

Albumin human 5% solution: 50–75 g recommended by one manufacturer.254

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;204 205 207 255 256 larger amounts may be required in those with severe hypoproteinemia who continue to lose albumin.204 205 Some manufacturers recommend a maximum dosage of 2 g/kg daily.208 210

Consider total body albumin deficit (including hidden extravascular albumin deficiency) when determining dosage necessary to reverse hypoalbuminemia.208 210 215 255 256 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.208 210 215

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.255 256

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.255 256

Cardiac Surgery
Cardiopulmonary Bypass
IV

Optimum fluid regimen to ensure adequate blood volume during cardiopulmonary bypass unclear.206 214 (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%.204 205 213 214

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;204 205 214 greater amounts may be required in patients with preexisting hepatic impairment or hypoproteinemia.204 205

Prescribing Limits

Pediatric Patients

IV

Hypovolemia or hypoproteinemia: maximum 2 g/kg daily recommended by some manufacturers.254 255 256

Maximum 6 g/kg in 24 hours or 250 g in 48 hours recommended by some clinicians.311

Adults

IV

Maximum 2 g/kg daily recommended by some manufacturers.254 255 256

Cautions for Albumin Human

Contraindications

  • Hypersensitivity to albumin,204 205 206 207 208 210 211 212 213 214 215 254 255 256 any ingredient in the formulation,254 255 256 or component of the container.254 255 256 (See Sensitivity Reactions under Cautions.)

  • Severe anemia.206 208 207 210 211 212 215

  • Cardiac failure206 207 208 210 211 212 215 in the presence of normal or increased intravascular volume.206 212

  • Consider that certain individuals are at particular risk of circulatory overload, including those with stabilized chronic anemia, CHF, or renal insufficiency.204 205 213 (See Renal Impairment under Cautions.)

  • Buminate 25%: Contraindicated in patients with chronic renal impairment because of risk of aluminum accumulation.215 (See Aluminum Content under Cautions.)

  • Dilution with sterile water for injection contraindicated because of risk of potentially life-threatening hemolysis and acute renal failure.125 127 128 129 130 133 134 135 136 137 138 184 204 205 206 207 208 210 214 215 254 255 256 (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).192 193 194 204 205 206 207 208 210 211 212 213 214 215 254 255 256

Donor plasma screening and viral elimination/inactivation procedures (e.g., pasteurization) have reduced, but not entirely eliminated risk of transmission of infectious agents.192 204 205 206 207 208 210 211 212 213 214 215 254 255 256

Risk of transmission of viral disease with plasma-derived albumin human is considered extremely remote.192 206 207 208 210 211 212 214 215 No causes of transmission of HBV, HCV, or HIV have been documented following use of commercially available albumin human.192 206 207 208 210 211 212 214 215 However, transmission of nonenveloped viruses, (e.g., hepatitis A virus [HAV] and parvovirus B19) has been documented following administration of plasma-derived coagulation factors.190

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.120 121 122 123 191 192 193 206 207 208 210 211 212 214 215 There have been 3 probable cases of vCJD acquired through transfusion of RBCs.202 For further information on CJD and vCJD precautions related to blood and blood products, consult the FDA guidance for industry on this topic ().192

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.196 197 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).195 196 198 199 For further information on WNV precautions related to blood and blood products, consult the FDA guidance for industry on this topic ().196

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.204 205 206 207 208 210 211 212 213 214 215

Report any infection believed to have been transmitted by albumin human to the manufacturer.204 205 207 208 210 211 213 214 215 254 255 256

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity reactions reported, including anaphylaxis or anaphylactoid reactions,207 208 210 215 252 253 254 255 256 fever,204 205 206 207 208 210 211 212 213 214 215 254 255 256 chills,204 205 206 207 208 210 211 212 213 214 215 254 255 256 rash,206 207 212 254 255 256 urticaria,204 205 207 208 210 211 213 214 215 254 255 256 pruritus,207 254 255 256 angioneurotic edema,254 255 256 and erythema or flushing.207 254 255 256

If an allergic or hypersensitivity reaction (e.g., anaphylaxis) occurs or is suspected, discontinue immediately and initiate appropriate therapy as indicated.207 208 210 215 254 255 256 Epinephrine should be readily available in case acute hypersensitivity occurs.254 255 256

Latex Sensitivity

Some packaging components of certain albumin human preparations (e.g., Buminate 5%, Buminate 25%) may contain natural latex proteins.210 215 Take appropriate precautions if these preparations are administered to individuals with a history of latex sensitivity.233 234 235

Some individuals may be hypersensitive to natural latex proteins;233 234 235 rarely, hypersensitivity reactions to natural latex proteins have been fatal.234 235

General Precautions

Hypervolemia/Hemodilution

Hypervolemia may occur if dosage and IV infusion rate are not adjusted based on patient's volume status.254 255 256 Rapid IV infusion may cause vascular overload.206 208 212 215

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).206 210 215 254 255 256

Use with caution in patients with low cardiac reserve (e.g., cardiac disease)204 205 206 207 212 and in those who do not have albumin deficiency.207 Use with great caution in patients with chronic anemia, hypertension, renal insufficiency, or severe pulmonary infections.206 207 211 214

Closely observe all patients (especially those with normal or increased circulatory volumes) for signs of increased venous pressure such as pulmonary edema.206 210 211 212 213 214

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.210 254 255 256

Hemodynamic Monitoring

Closely monitor hemodynamic performance;208 210 215 254 255 256 evaluate patient for evidence of cardiac, respiratory, or renal failure or increasing intracranial pressure.208 210 215 254 255 256

Frequently monitor arterial BP and pulse rate, central venous pressure, pulmonary artery occlusion pressure, urine output, electrolytes, hemoglobin, and hematocrit.254 255 256

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.204 205 206 207 208 210 212 213 215 To prevent hemorrhage and shock, carefully observe such patients and treat appropriately.204 205 206 207 208 210 212 213 215

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.254 255 256

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.208 210 215 254 255 256

Electrolyte Imbalance

Monitor electrolyte status; take appropriate steps to restore or maintain electrolyte balance.208 210 215 254 255 256

Compared with albumin human 5% solution, albumin human 20 and 25% solutions are relatively low in electrolytes.255 256

Sodium Content

All commercially available albumin human preparations contain 130–160 mEq of sodium per L.139 204 205 206 207 208 210 211 212 213 214 215 254 255 256

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.37 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 184

Hypotonic dilutions can cause life-threatening hemolysis and acute renal failure.125 127 128 129 130 133 134 135 136 137 138 184 204 205 206 207 208 214 215

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.124 125 126 127 129 130 133 138 184 Such dilutions are markedly hypotonic with respect to blood, with calculated resultant sodium concentrations of 26–32 mEq/L.124 125 126 127 129 130 133

Because of risk of potentially life-threatening hemolysis and acute renal failure, albumin human must not be diluted with sterile water.125 127 128 129 130 133 134 135 136 137 138 184 204 205 206 207 208 210 214 215 254 255 256 (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).101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 140 141 142 143 144 145 215

Consider possibility that aluminum could accumulate in patients with impaired renal function.101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 140 141 142 144 145 215

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.101 106 141 144 145

Manufacturer states that Buminate 25% should not be used in patients with chronic renal impairment because of risk of aluminum accumulation.215

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]).206 211 212 214 247 248 249

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).246

Specific Populations

Pregnancy

Category C.204 205 206 207 208 210 211 212 213 214 215 254 255 256

Consider potential risks and benefits for the specific patient.208 210 215 Use in pregnant women or during labor and delivery only if clearly needed.204 205 206 207 208 210 211 212 213 214 215 254 255 256 One manufacturer states that there is no evidence for any contraindications specifically associated with reproduction, pregnancy, or the fetus.211 214

Lactation

Not known whether distributed into milk.254 255 256 Use caution and only when clearly needed.254 255 256

Pediatric Use

Manufacturers of Albuminar and Plasbumin state safety and efficacy not established in pediatric patients.204 205 207 213

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.208 210 215

Some manufacturers state data regarding use in pediatric patients, including premature infants, are limited.254 255 256 Weigh benefits and risks206 212 and use in pediatric patients only when clearly needed.254 255 256

Has been used as an adjunct to exchange transfusions in the treatment of neonatal hyperbilirubinemia, including hemolytic disease of the newborn (erythroblastosis fetalis).187 204 205 206 208 214 215 Not indicated when neonatal hyperbilirubinemia is treated using phototherapy without exchange transfusions.134 187 (See Neonatal Hyperbilirubinemia under Uses.) Use caution in hypervolemic infants.204 205 214

Some clinicians state albumin human 25% is contraindicated in preterm infants because of risk of intraventricular hemorrhage.311

Risk of aluminum accumulation and associated toxicity in premature neonates.141 142 143 A preparation with low aluminum may be preferred in neonates and premature infants.246 (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.254 255 256

Renal Impairment

Increased risk of circulatory overload.204 205 213 214 Use caution in hemodialysis patients or other patients with renal impairment and closely observe for signs of circulatory overload.204 205 211 213 214 215 254 255 256

Risk of aluminum accumulation and associated toxicity.101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 140 141 142 144 145 215 (See Aluminum Content under Cautions)

Common Adverse Effects

Anaphylactoid reactions,254 255 256 fever,204 205 206 207 208 211 210 212 213 214 215 254 255 256 chills,204 205 206 207 208 210 211 212 213 214 215 254 255 256 rash,206 207 212 254 255 256 nausea,206 207 208 210 211 212 214 215 254 255 256 vomiting,206 207 208 210 212 215 254 255 256 tachycardia,206 208 210 212 215 254 255 256 hypotension.206 207 208 210 211 212 214 215 252 254 255 256

Interactions for Albumin Human

Specific drug interaction studies not performed using albumin human.208 210 215 254 255 256

Specific Drugs

Drug

Interaction

Comments

ACE inhibitors

Increased risk of atypical reactions (e.g., flushing, hypotension) to ACE inhibitors in patients undergoing therapeutic plasma exchange with albumin human replacement182

Withhold ACE inhibitors ≥ 24 hours prior to plasma exchange in which large volumes of albumin human are given182

Stability

Storage

Parenteral

Injection

Store in tight containers at temperature recommended by manufacturer or indicated on label.204 205 206 207 208 210 211 212 213 214 215 254 255 256 Protect from light.254 255 256

Most commercially available albumin human 5, 20, or 25% solutions should be stored at ≤30°C.204 205 206 207 208 210 211 212 213 214 215

Do not freeze;204 205 206 207 208 210 211 212 213 214 215 254 255 256 do not use solutions that have been frozen.204 205 210 213

Do not use if solution appears turbid or contains sediment.204 205 206 207 208 210 211 212 213 214 215 254 255 256

Use immediately after opening;254 255 256 do not use if >4 hours have elapsed since vial or container was first entered.204 205 206 207 208 210 211 212 213 214 215

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

May be administered in conjunction with whole blood or plasma, or with dextrose, sodium lactate, or sodium chloride injections.135 204 205 206 207 208 210 211 212 213 214 215

Do not mix with parenteral nutrient solutions,257 protein hydrolysates,204 205 206 208 210 212 213 214 215 amino acid solutions,204 205 213 214 or solutions containing alcohol204 205 206 208 210 212 213 214 215 since proteins may precipitate in the solutions.206 212 213 (See Dilution under Dosage and Administration.)

Parenteral

Solution CompatibilityHID

Compatible

Dextrose–Ringer’s injection combinations

Dextrose–Ringer’s injection, lactated, combinations

Dextrose–saline combinations

Dextrose 2.5, 5, or 10% in water

Ionosol products

Ringer’s injection

Ringer’s injection, lactated

Sodium chloride 0.45 or 0.9%

Sodium lactate (1/6) M

Drug Compatibility
Admixture CompatibilityHID

Incompatible

Verapamil HCl

Y-Site CompatibilityHID

Compatible

Diltiazem HCl

Lorazepam

Incompatible

Fat emulsion, IV (Intralipid)

Micafungin sodium

Midazolam HCl

Vancomycin HCl

Verapamil HCl

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.204 205 206 207 208 210 211 212 213 214 215 254 255 256

  • 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.206 208 210 211 212 215 226 254 255 256

  • 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.204 205 206 207 208 214 215 254 255 256

  • In the US, albumin human is commercially available as 5, 20, or 25% solutions;204 205 206 207 208 210 211 212 213 214 215 254 255 256 other concentrations (e.g., 4% solutions) are available in other countries.250

  • 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.210 211 212 213

  • 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.204 205 206 207 208 215

  • 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.204 205 206 207 208 210 212 215 In patients with normal blood volume, excess fluid and protein are lost from the circulation within a few hours.204 205 206 207 208 210 212 215

  • When used for treatment of hypovolemia, most effective in well-hydrated patients.208 215 254 255 256

  • Not considered and not used as an IV nutrition source.21 204 206

  • 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.20 21 204 205 208 213 226 230 231

Advice to Patients

  • Advise patient and/or patient's caregiver of the benefits and risks of albumin human.204 205 206 207 208 210 211 212 213 214 215 254 255 256

  • Advise patient and/or patient's caregiver that albumin human is prepared from pooled human plasma.204 205 206 207 208 210 211 212 213 214 215 254 255 256 Improved donor screening and viral-inactivating procedures used in manufacture of plasma-derived preparations have reduced, but not entirely eliminated, risk of pathogen transmission.204 205 206 207 208 210 211 212 213 214 215 254 255 256 (See Risk of Transmissible Agents in Plasma-derived Preparations under Cautions.)

  • Importance of reporting any infection believed to have been transmitted by albumin human.204 205 207 208 210 211 213 214 215 254 255 256

  • 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.254 255 256

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.204 205 206 207 208 210 211 212 213 214 215

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.204 205 206 207 208 210 211 212 213 214 215 254 255 256

  • Importance of informing patients of other important precautionary information. 204 205 206 207 208 210 211 212 213 214 215 254 255 256 (See Cautions.)

Preparations

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

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

Albumin Human

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for IV infusion

50 mg/mL*

Albuminar-5

CSL Behring

Albumin Human 5%

AlbuRx 5

CSL Behring

Albutein 5%

Grifols

Buminate 5%

Baxter

Plasbumin-5

Talecris

200 mg/mL*

Albumin Human 20%

Plasbumin -20

Talecris

250 mg/mL*

Albuminar-25

CSL Behring

Albumin Human 25%

Albutein 25%

Grifols

AlbuRx 25

CSL Behring

Buminate 25%

Baxter

Flexbumin 25%

Baxter

Plasbumin-25

Talecris

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions September 28, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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21. Tullis JL. Albumin 2: guidelines for clinical use. (From the Proceedings of the Workshop on Albumin, National Institutes of Health, Bethesda, MD: 1975 Feb 12-14.) JAMA. 1977; 237:460-3.

24. Thompson WL. Rationale use of albumin and plasma substitutes. Johns Hopkins Med J. 1975; 136:220-5. [IDIS 54331] [PubMed 47936]

30. Ranson JHC, Turner JW, Roses DF et al. Respiratory complications in acute pancreatitis. Ann Surg. 19974; 179:557-66.

36. Food and Drug Administration. Normal serum albumin (human) and plasma protein fraction (human): proposed additional standards. Proposed rule (Docket No. 75-4593). Fed Regist. 1975; 40:7456-60.

37. Food and Drug Administration. Normal serum albumin (human) and plasma protein fraction (human). Final rule (Docket No. 77N-0047). Fed Regist. 1977; 42:27575-84.

101. Milliner DS, Shinaberger JH, Shuman P et al. Inadvertent aluminum administration during plasma exchange due to aluminium contamination of albumin-replacement solutions. N Engl J Med. 1985; 312:165-7. [IDIS 194870] [PubMed 3965935]

102. El Habib R, Eygonnet JP. Aluminum bone disease. BMJ. 1987; 295:1415-6. [PubMed 3121039]

103. Maher ER, Brown EA, Curtis JR et al. Accumulation of aluminium in chronic renal failure due to administration of albumin replacement solutions. BMJ. 1986; 292:306. [PubMed 3080148]

104. Maharaj D, Fell GS, Boyce BF et al. Aluminium bone disease in patients receiving plasma exchange with contaminated albumin. BMJ. 1987; 295:693-6. [IDIS 234639] [PubMed 3117305]

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107. Holberg CP. Aluminum in parenteral products: overview of chemistry concerns and regulatory actions. J Parenter Sci Tech. 1989; 43:127-31.

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122. 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.)

123. Department of Health and Human Services, Food and Drug Administration. Disposition of products derived from donors diagnosed with, or at known high risk for, Creutzfeldt-Jakob disease. 1995 Aug 8. Memorandum.

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

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149. Feigal D. Dear Doctor letter regarding medical administration of albumin or plasma protein fraction to seriously ill patients. Rockville, MD: Food and Drug Administration; 1998 Aug 19.

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