Adult Dosing

General considerations for albumin administration

• Individualize rate of infusion based on indication, concentration of albumin human solution used, clinical status and response of the patient. Consult manufacturers’ information for recommended rates of administration
• The concentration of albumin human to be used (i.e, 4, 5, 20, or 25% solution) depends on the fluid and protein requirements of each individual patient and needs to be determined on the basis of need for volume or oncotic replacement
• 5% solutions usually are preferred in the treatment of acute blood volume deficits in the absence of adequate or excessive hydration, whereas 20 or 25% solutions are preferred when there is an oncotic deficit or when hypovolemia is long standing and hypoalbuminemia exists in the presence of adequate or excessive hydration
• If used for treatment of hypovolemia, albumin human solutions are most effective in well-hydrated patients. In dehydration, the 5% solution usually is preferred, if the 20 or 25% solutions are used in dehydrated patients, additional crystalloids or other fluids should be concomitantly administered
• 20 or 25% solutions are preferred when the drug is being used for its binding rather than oncotic effects (e.g., neonatal hyperbilirubinemia)

Hypovolemia

• 12.5-37.5 g (250-750 mL) IV of 5% solution; may repeat dose x1 in 15-30 minutes if response is inadequate; alt: 25-50 g (100-200 mL) IV of 25% solution; may repeat initial dose after 10-30 minutes if response is inadequate. Max: 2 g/kg

Notes

• Transfuse patient appropriately in the event of blood volume deficit, especially if due to hemorrhage
• Albumin replacement is best administered in the form of 5% albumin human in patients with significant plasma volume deficits

Hypoproteinemia

Notes

• Treatment of the underlying cause of hypoproteinemia remains the primary goal; albumin may relieve edema associated with hypoproteinemia by increasing colloid osmotic pressure and producing diuresis. Albumin use in patients with severe hypoalbuminemia who do not have manifestations of hypovolemia, in an attempt to increase serum albumin concentrations is not recommended
• Consider total body albumin deficit (hidden extravascular deficiency) to determine the amount of albumin for reversing hypoproteinemia. When using serum albumin concentration to estimate the deficit, calculate the body albumin space as 80-100 mL/kg
• Some manufacturers recommend a daily dose of 50-75 g (250-375 mL of 20% solution or 200-300 mL of a 25% solution or 1000-1500 mL of 5% solution). Max daily dose: 2 g/kg
• When hypovolemia is long-standing and hypoproteinemia exists in the presence of adequate hydration or edema, 20-25% solutionsare preferable to the 5% solution

Shock

• Initial dose: 25 g (500 mL) IV of 5% solution; alt: 20 g (100 mL) IV of 20% solution or 25 g (100 mL) IV of the 25% solution. It is important to note, that when a 20-25% solution is used, it must either be diluted or concomitant crystalloid must be administeredwhen given to patients in shock
• The Society of Transfusion Medicine and Immunohaematology has reviewed this indication for albumin and indicates that if the shock is non-hemorrhagic, this is an "Inappropriate indication" for use of albumin

Burns

Notes

• The optimum regimen of crystalloids, colloids, electrolytes, and fluids for the management of burn injuries has not been clearly established
• It is typical to administer large volumes of crystalloids initially to maintain adequate urinary output and maintain plasma volume. If albumin is administered, it generally should not be administered until 24 hours after a burn
• Adjust dose to maintain a plasma protein concentration of 2-3 g/dL or a serum protein concentration of around 5.2 g/dL
• Therapy beyond 24 hours requires more albumin and less crystalloid solution for preventing marked hemoconcentration and maintaining electrolyte balance
• Albumin levels >4.0 g/dL may cause an increased catabolic rate

Dosage

• Albumin 5% is indicated post 24 hrs using doses according to the amount of body surface area (BSA) involved as mentioned below
• BSA 30-50%: 0.3 mL x kg x % of burnt BSA, in 24 hours
• BSA 50-70%: 0.4 mL x kg x % of burnt BSA, in 24 hours
• BSA 70-100%: 0.5 mL x kg x % of burnt BSA, in 24 hours

• In the post-resuscitation phase, albumin 5% or 20% is can be infused at a dose of 1-2 g/kg/day if serum albumin < 1 g/dL (end-point 2 g/dL) or if serum albumin is 1-2 g/dL and the patient cannot tolerate an enteral diet, has pulmonary dysfunction or has massive edema

Cardiopulmonary bypass

• Some manufacturers recommend adjusting albumin and crystalloid pump prime solutions to achieve a 20% hematocrit count and a plasma albumin concentration of 2.5 g/dL
• Note: Optimum fluid regimen to ensure adequate blood volume during CABG is unclear. Albumin is considered the last-choice of treatment after crystalloids and non-protein colloids

Adjunctive treatment for edema in acute nephrosis

• 20-25 g IV q24 hrs x 7-10 days in conjunction with an appropriate diuretic

Renal dialysis

• 25 g (100 mL) IV of 25% solution for treatment of shock, hypotension or volume or oncotic deficit; carefully monitor for signs of circulatory overload
• The Society of Transfusion Medicine and Immunohaematology has reviewed this indication for albumin and indicates it to be an "Inappropriate indication"

Prevention of central volume depletion after paracentesis due to cirrhotic ascites

• 8 g (160 mL) IV of 5% solution for every 1000 mL of ascitic fluid removed; alt 6-8 g (24-32 mL) IV of 25% solution for every 1000 mL of ascitic fluid removed

Hepatorenal syndrome

• Albumin should be used in conjunction with vasoconstrictors. Some experts recommend a dose of 1 g/kg (max: 100 g) of albumin human on day 1, followed by 20-40 g once daily. If response is observed, treatment should be continued until serum creatinine concentrations < 1.5 mg/dL. Discontinue therapy if serum albumin levels exceed 4.5 g/dL or if pulmonary edema is present

Adjunct to anti-infectives in the treatment of spontaneous bacterial peritonitis

• The American Association for the Study of Liver Diseases recommended dose: Patients with ascitic fluid polymorphonuclear counts 250 cells/mm³ and serum creatinine >1 mg/dL, BUN> 30 mg/dL, or total bilirubin > 4 mg/dL should receive 1.5 g/kg within 6 hrs. Another dose of 1 g/kg should be given on day 3 (mortality decreased from 29% to 10% in one controlled trial with use of albumin versus none in this setting)

Acute liver failure

• Individualize albumin 5-25% solution, with dose based on the clinical situation

Ovarian Hyperstimulation Syndrome

• Human albumin 20 or 25% solution is used for plasma expansion in severe ovarian hyperstimulation syndrome. Some manufacturers recommend a dose of 50-100 g IV over 4 hrs and repeated q4-12 hrs as required
• The Society of Transfusion Medicine and Immunohaematology has reviewed this indication for albumin and indicates it to be an "Inappropriate indication"

Acute respiratory distress syndrome

• In conjunction with a diuretic, albumin human albumin solution is used for management of fluid overload. A dose of 25 g IV over 30 mins may be given and repeated q8 hrs x 3 days if required

Erythrocyte resuspension

• 20-25 g (80-100 mL) IV of 25% solution per liter of isotonic suspended RBCs immediately prior to transfusion

Pediatric Dosing

Hypovolemia

Neonates, infants and children

• 0.5-1.0 g/kg (10-20 mL) IV of 5% solution; rate: 5-10 mL/min; may repeat dose after 15-30 minutes if response is inadequate; Max: 6 g/kg/24hr

• Albumin replacement is best administered in the form of 5% solution in patients with significant plasma volume deficits. Transfuse patient appropriately in the event of blood volume deficit, especially if due to hemorrhage
• Treatment should be based on hemodynamic response and not by blood volume calculations or measurements. Assess clinical response, blood pressure and relative anemia during therapy

Neonatal hyperbilirubinemia including hemolytic disease of the newborn

• 1 g/kg (4 mL) IV of 25% solution; administer 1 hour prior during exchange transfusion in jaundiced infants

Hypoproteinemia

• Child: 0.5-1 g/kg/dose IV over 30-120 mins; repeat q1-2 days as required
• Max: 2 g/kg/24 hr

[Outline]

• Adult Dosing
• Pediatric Dosing

• Plasma volume expansion in the emergency treatment of hypovolemia with or without shock and other conditions where urgent restoration of blood volume is required
• Management of severe hypoalbuminemia (with or without edema) to restore serum albumin concentrations
• Fluid resuscitation in patients with hemorrhagic shock. Albumin is used as a third choice in this setting. Crystalloids and blood products (packed red blood cells, fresh frozen plasma, platelets) are the recommended fluids for hemorrhagic shock
• Subjects undergoing major surgery [eg, extensive intestinal resection] when, after normalisation of circulatory volume, serum albumin levels are < 2 g/dL. Albumin is not recommended in the immediate post-operative period of any other surgery
• Fluid resuscitation in burns [In conjunction with crystalloid therapy for treatment of oncotic deficits post 24-hour following extensive burns]. Albumin is not recommended in resuscitation phase in the first 24 hours after burn injuries due to increased capillary permeability
• Prior to or during cardiopulmonary bypass surgery for preoperative dilution of blood, usually in conjunction with a crystalloid. However studies have demonstrated marginal or no additional benefit of colloids in the preoperative regimen
• Post-operative period following liver transplantation in order to control ascites and peripheral edema. Therapy can be considered if serum albumin is <2.5 g/dL, pulmonary capillary pressure is < 12 mmHg and hematocrit > 30%
• Albumin is considered appropriate for therapeutic plasmapheresis for exchange of large volumes of plasma: >20 mL/kg in a single session or 20 mL/kg/week in successive sessions
• As an adjunct to diuretics for management of edema in patients with acute nephrosis who are refractory to cyclophosphamide and corticosteroid therapy
• Short-term adjunctive use of albumin 20%-25% can be considered appropriate if serum albumin < 2 g/dL, presence of marked hypovolemia and/or acute pulmonary edema and/or acute renal failure. Human albumin has no role in chronic nephrosis as it is rapidly excreted renally with no effect on chronic edema
• As an adjunct to hemodialysis in patients undergoing prolonged dialysis or in patients experiencing shock or hypotension unable to tolerate substantial volumes of crystalloids
• Prevention of central volume depletion after paracentesis in cirrhotic ascites in patients who require removal of large volumes of ascitic fluid. Single paracentesisvolume of 4-5 L can probably be safely performed without colloid support; however, for large volume paracentesis (> 5 L), albumin human is recommended to decrease the risk of hypovolemia, dilutional hyponatremia, deterioration of renal function, rapidly recurrent ascites and shortened survival
• Hepatorenal syndrome (HRS): The treatment of choice for hepatorenal syndrome is liver transplantation. Albumin human has been used in conjunction with vasoconstrictors for the treatment of type I hepatorenal syndrome in patients with cirrhosis.Use of albumin human to expand intravascular volume and vasoconstrictors to increase vascular tone in patients with rapidly progressing disease may improve renal function and improve outcomes of surgery
• Albumin used as an adjunct to anti-infectives in the treatment of spontaneous bacterial peritonitis in patients with cirrhosis and ascitesmay decrease the risk of renal impairment and subsequent progression to HRS
• Acute liver impairment to support plasma colloid osmotic pressure and for binding excess plasma bilirubin
• Detoxification of unconjugated bilirubin in infants with severe hemolytic disease
• Plasma expander for fluid management in severe forms of ovarian hyperstimulation syndrome
• As an adjunct with diuretics for correcting fluid volume overload associated with adult respiratory distress syndrome
• To resuspend large volumes of previously frozen or washed RBCs prior to administration or during certain types of exchange transfusion
• Nutritional support: Albumin should not be used for malnutrition syndromes. Oral, enteral, and/or parenteral nutrition with amino acids and treatment of underlying disorders will restore plasma protein concentrations.However, patients with diarrhea who cannot tolerate enteral nutrition may benefit from albumin human if they have severe diarrhea (>2 L/day) and a serum albumin concentration <2 g/dL or if diarrhea occurs despite a trial of short-peptide and elemental formulas and other causes of diarrhea have been excluded

• Hypersensitivity to any of the ingredients of the product
• Severe anemia
• Cardiac failure
• History of CHF (relative contraindication)
• Renal insufficiency
• Stabilized chronic anemia

Conditions where human albumin is inappropriate

• Hypoalbuminemia in the absence of edema and acute hypotension
• Albuminemia >2.5 g/dL
• Malnutrition
• Non-hemorrhagic shock
• Ascites (responsive to diuretics)
• Burns (first 24 hours)
• Protein-losing enteropathies and malabsorption
• Acute or chronic pancreatitis
• Cerebral ischemia
• Acute normovolemic hemodilution in surgery
• Wound healing

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined
• Dialysis: <100 mL of the 25% solution

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Hypersensitivity or allergic reactions have been linked with albumin human use. Severe anaphylaxis may occur in some cases. Serious adverse effects e.g., anaphylaxis, cardiac failure, circulatory failure, pulmonary edema, including some fatalities have been reported. On suspicion of allergic or anaphylactic type reactions immediately discontinue injection. Institute standard medical treatment in case of shock
• As hypervolemia may occur, adjust dose and rate of infusion as per the patient’s volume status
• Immediately stop the infusion and re-evaluate patient on first clinical signs of possible cardiovascular overload (e.g., headache, dyspnea, increased blood pressure, jugular venous distention, elevated central venous pressure, pulmonary edema). Administer the solution slowly to avoid too rapid a rise in the blood pressure. Adjust the rate of administration according to the solution concentration and the patient’s hemodynamic measurements
• During albumin therapy, monitor electrolyte levels and take appropriate steps to restore or maintain the electrolyte balance
• Monitor coagulation indices, and hematocrit if comparatively large volumes are to be replaced. Adequate substitution of coagulation factors, electrolytes, platelets and erythrocytes is essential
• If indicated, may require regular monitoring of arterial blood pressure, pulse rate, central venous pressure, pulmonary artery occlusion pressure, urinary output, electrolytes, hematocrit/hemoglobin
• Dilution should be with normal saline, as sterile water may cause hemolysis and acute renal failure
• For administration of concentrated albumin in patients with hypertension or mild congestive failure, dilute 25% solution with 5% or 10% glucose solution to reduce the albumin concentration to 10%. Administer the diluted solution safely at the rate of 100 mL/hour
• Close monitoring of hemodynamics parameters (evidence of cardiac or respiratory failure, renal failure, or increasing intra-cranial pressure) is essential during administration of albumin human 5% solution
• During or following albumin use administer additional fluids if dehydration is present. To treat anemia, transfuse with packed red blood cells
• Administration of additional crystalloids may be essential to maintain normal fluid balance
• Ensure adequate hydration during administration of concentrated albumin solution. Carefully monitor to guard against circulatory overload
• As albumin human is prepared using pooled human plasma, it is a potential vehicle for transmission of human viruses (e.g., hepatitis A virus, hepatitis B virus hepatitis C virus, human immunodeficiency virus and theoretically carries a risk of transmitting the causative agent of Creutzfeldt-Jakob disease (CJD) or related agents such as variant CJD
• As the product contains no antimicrobial preservative use of turbid solutions is not recommended

Cautions: Use cautiously in

• Cardiac disease
• Decompensated cardiac insufficiency
• Patients with low cardiac reserve
• Hypertension
• Hypotension
• Hypervolemia
• Absence of albumin deficiency
• Hypoalbuminemia with peripheral edema
• Esophageal varices
• Pulmonary edema
• Severe pulmonary infection
• Hemorrhagic diathesis
• Severe anemia
• Renal and post-renal anuria
• Hypervolemia
• Renal failure
• Post Renal failure

Pregnancy Category:C

Breastfeeding: It is not known whether this drug is excreted in human milk. Manufacturer advises caution

• CNS: Headache dizziness malaise, weakness, fatigue
• CV: Chest pain
• DERM: Warm sensation, flushing, injection site discomfort, erythema
• GI: Nausea, vomiting. altered taste
• RESP: Dyspnea
• MISC: Chills, fever, flu-like symptoms

• Plasma protein fraction; acts as a high molecular weight soluble osmolyte. It is a protein colloid that regulates plasma volume and tissue fluid balance through its contribution to the colloidal oncotic pressure. Albumin causes a shift of fluid from the interstitial spaces into the circulation, thereby reducing hemoconcentration and blood viscosity
• Metabolism: Unknown
• Elimination: Unknown
• Half-life: 15-20 days

US Trade Name(s)

• Albumarc 25%
• Albumarc 5%
• Albuminar-20
• Albuminar-25
• Albuminar-5
• Alburx 25
• Alburx 5
• Albutein 25%
• Albutein 5%
• Buminate 25%
• Buminate 5%
• Flexbumin 25%
• Kedbumin
• Plasbumin-25
• Plasbumin-5

US Availability

• Note: 4% = 40 mg/mL, 5% = 50 mg/mL, 20% = 200 mg/mL and 25% = 250 mg/mL

albumin human (generic)

• INJ: 5% (100, 250, 500 mL glass bottles)
• INJ: 25% (20, 50, 100 mL vials)

Albumarc 5%, Buminate 5 %

• INJ: 5% (250, 500 mL glass bottles)

Albumarc 25%, Buminate 25%

• INJ: 25% (50, 100 mL glass bottles)

Albuminar-5

• INJ: 5% (50 mL vials, 250 and 500 mL bottles)

Albuminar-20

• INJ: 20% (50, 100 mL vials)

Albuminar-25, Plasbumin-25

• INJ: 25% (20, 50, 100 mL vials)

Plasbumin-5

• INJ: 5 % (50, 250, 500 mL vials)

Alburx 5, Albutein 5

• INJ: 5% (250, 500 mL vials)

Alburx 25, Albutein 25

• INJ: 25% (50, 100 mL vials)

Flexbumin 25%

• INJ: 25% (50, 100 mL plastic containers)

Kedbumin

• INJ: 25% (50 mL vials)

Canadian Trade Name(s)

• Alburex 5
• Alburex 25
• Albutein 5%
• Albutein 25%
• Buminate 5%
• Buminate 25%
• Plasbumin-5
• Plasbumin-25

Canadian Availability

albumin human (generic)

• INJ: 5% (50, 250, 500 mL vials)
• INJ: 25% (50,100 mL vials)

Alburex 5

• INJ: 5% (100, 250, 500 mL bottles)

Alburex 25

• INJ: 25% (50, 100 mL bottles)

Albutein 5%

• INJ: 5%

Albutein 25%

• INJ: 25%

Buminate 5%

• INJ: 5% (250, 500 mL bottles)

Buminate 25%

• INJ: 25% (20, 50,100 mL bottles)

Plasbumin-5

• INJ: 25% (50, 250 mL vials)

Plasbumin-25

• INJ: 25% (100 mL vials)

UK Trade Name(s)

• Albunorm 5%
• Albunorm 20%
• Alburex 5%
• Alburex 20%
• Zenalb 4.5
• Zenalb 20

UK Availability

albumin human (generic)

• INJ: 5%
• INJ: 20%

Albunorm 5%, Alburex 5%

• INJ: 5% (100, 250, and 500 mL glass bottles)

Albunorm 20%, Alburex 20%

• INJ: 20% (50 and 100 mL glass bottles)

Zenalb 4.5

• INJ: 4.5% (100 mL vial)

Zenalb 20

• INJ:20% (100 mL vial)

Australian Trade Name(s)

• Albumex 4
• Albumex 20

Australian Availability

• Note: 4% = 40 mg/mL, 5% = 50 mg/mL, 20% = 200 mg/mL and 25% = 250 mg/mL

Albumex 4 (40 mg/mL)

• INJ: 2 g/50 mL (50 mL glass bottles)
• INJ: 20 g/500 mL (500 mL glass bottles)

Albumex 20 (200 mg/mL)

• INJ: 2g/10 mL (10 mL glass bottles)
• INJ: 20 g/100 mL ( 100 mL glass bottles)

[Outline]

Cardiovascular

Plasma Expanders