Albumin is a parenteral colloid indicated for hypovolemia, hypoalbuminemia, prevention of central volume depletion after paracentesis due to cirrhotic ascites, ovarian hyperstimulation syndrome, adult respiratory distress syndrome, acute nephrosis, hemolytic disease of the newborn, burns, cardiopulmonary bypass surgery, and erythrocyte resuspension during exchange transfusion to prevent hypoproteinemia. The main clinical indications are for hypoproteinemic states involving reduced oncotic pressure, with or without edema. Albumin is made from large pools of human venous plasma by the Cohn cold ethanol fractionation process. As with other products derived from or purified with human blood components, the remote possibility of contamination with Creutzfeldt-Jakob disease (CJD) or other viral infections exists in patients receiving albumin. The manufacturing processes are designed to reduce the risk of transmitting viral infection. No cases of transmission of viral illness or CJD have ever been identified for albumin.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
-Albumin is a transparent or slightly opalescent solution which may have a greenish tint or may vary from pale straw to amber color.
-Albumin may be given undiluted. Acceptable diluents include 0.9% Sodium Chloride Injection or 5% Dextrose Injection; do NOT dilute with Sterile Water for Injection.
-Do not mix or add with other medicinal products including blood and blood components, protein hydrolysates, or solutions containing alcohol. Do not add supplementary medication.
-Storage: Administer within 4 hours of entering the container.
-Adjust infusion rate to the patient's individual requirements. Do not exceed 1 to 2 mL/minute for patients with normal blood volume. More rapid administration can cause circulatory overload and pulmonary edema.
-Monitor hemodynamic parameters and for the risk of hypervolemia and cardiovascular overload.
-For the treatment of acute respiratory distress syndrome (ARDS), administer each dose over 30 minutes.
Adverse reactions to albumin are rare. Reactions are often allergic or due to high plasma protein concentrations or fluid overload from excessive albumin administration. Adverse reactions normally resolve when the infusion rate is slowed or the infusion is discontinued. For severe reactions, discontinue albumin and institute appropriate treatment.
Hypotension, circulatory failure, heart failure, and sinus tachycardia may occur with albumin administration. Slowing or stopping the infusion for a short period of time may alleviate these symptoms. Hypervolemia may occur if the dosage and rate of infusion of albumin are too high; stop the infusion and reevaluate the patient at the first signs of possible volume overload. Changes in pulse blood pressure may be a component of an allergic reaction. Hypertension, flushing, bradycardia, atrial fibrillation, and myocardial infarction have been reported with postmarketing use.
Fever, chills, hyperhidrosis, and edema have been reported with albumin use. These symptoms may be a component of an allergic reaction.
Aluminum toxicity is rare but may be seen with high doses and/or prolonged use of aluminum-containing albumin products. Accumulation at concentrations associated with central nervous system and bone toxicity is more likely to occur in patients with impaired renal function.
Pulmonary edema, dyspnea, and bronchospasm have been reported with albumin use. Changes in respiration may be a result of an allergic reaction or hypervolemia. If hypervolemia is suspected, adjust dose and rate of infusion to the patient's volume status. Discontinue albumin administration at the first sign of cardiovascular overload or if hypersensitivity is suspected.
Anaphylactoid reactions are the most common adverse events seen with albumin. Hypersensitivity/allergic reactions including anaphylactic shock, angioedema, urticaria, rash, erythematous rash, and pruritus have been reported with albumin use. Allergic manifestations may also include changes in respiration, pulse, and blood pressure.
Nausea (1% to 2%), abdominal pain (1%), hypersalivation, and vomiting have been reported with albumin use. Slowing or stopping the infusion for a short time may alleviate these symptoms. Nausea and vomiting may be a component of an allergic reaction.
Albumin is a derivative of human blood and carries an extremely remote risk of infection via transmission of viral disease and Creutzfeldt-Jakob disease (CJD). No cases have ever been identified for licensed albumin products. Risk has been reduced via the donor screening and manufacturing processes. During clinical trials, urinary tract infection (3%) was reported in patients receiving albumin; however, causality has not been established.
Headache, confusion, and loss of consciousness have been reported during postmarketing use of albumin.
Use of albumin is contraindicated in patients with a history of albumin hypersensitivity or hypersensitivity to any of the excipients. Discontinue administration immediately and institute appropriate medical treatment if a hypersensitivity reaction is suspected.
Albumin is contraindicated in patients with severe anemia or heart failure with normal or increased intravascular volume. Under conditions where hypervolemia and/or hemodilution may occur, adjust the albumin dose and rate of infusion to the patient's volume status. Monitor coagulation and hematology parameters when large volumes are replaced. Ensure adequate substitution of other blood constituents (e.g., coagulation factors, platelets, erythrocytes). Monitor electrolyte status and take appropriate steps to address electrolyte imbalance. Discontinue albumin administration at the first sign of cardiovascular overload (e.g., headache, dyspnea, jugular venous distention, rales, hypertension). Albumin increases plasma volume and can cause vascular overload, especially after rapid infusion. Patients with preexisting heart failure, hypertension, esophageal varices, pulmonary edema, coagulopathy, severe anemia, or renal failure are at increased risk of hypervolemia and/or hemodilution. Monitor blood pressure in trauma and postoperative surgery patients in order to detect rebleeding secondary to clot disruption. Closely monitor hemodynamic parameters for evidence of increased intracranial pressure and cardiac, respiratory, or renal failure in all patients.
Aluminum toxicity is rare but may be seen with high doses and/or prolonged use of aluminum-containing albumin products. Accumulation at concentrations associated with central nervous system and bone toxicity is more likely to occur in patients with renal disease or in premature neonates with immature kidneys.
Albumin is a derivative of human blood. As with other products derived from or purified with human blood components, the remote possibility of contamination with Creutzfeldt-Jakob disease (CJD) or other viral infections exists in patients receiving albumin. The manufacturing processes are designed to reduce the risk of transmitting viral infection. No cases of transmission of viral illness or CJD have ever been identified for albumin. Report all infections thought to have been transmitted by albumin to the manufacturer.
Patients with marked dehydration require the administration of additional fluids when treated with concentrated albumin. The colloid-osmotic effect of 25% albumin is approximately 5-times that of blood plasma. Monitor patients carefully to guard against circulatory overload and hyperhydration.
It is not known whether albumin products can cause fetal harm or affect reproductive capacity when administered to a pregnant woman. No human or animal data are available to indicate the presence or absence of drug-associated risk with albumin use during pregnancy.
It is not known whether albumin is excreted in human milk. No human or animal data are available to indicate the presence or absence of drug-associated risk with albumin use while breast-feeding.
For the treatment of shock due to hypovolemia:
NOTE: Dosage should be based on patient response as indicated by blood pressure, degree of pulmonary congestion, and hematocrit.
Adults: Initially, rapidly administer 5% solution IV. As the plasma volume approaches normal, infuse IV at a rate <= 2-4 mL/minute (rate of 25% solution <= 1 mL/minute). May repeat initial dose in 15-30 minutes. Continued protein loss may require administration of whole blood and/or other blood factors.
Children: 0.5-1 g/kg/dose IV. May repeat as needed. Maximum dosage is 6 g/kg/day.
Neonates: The usual dose is 0.5 g/kg IV as a 5% solution; however, dosages may range from 0.25-0.5 g/kg IV. The 25% solution should be avoided in preterm neonates due to the risk of intraventricular hemorrhage.
For adjunctive treatment of severe burns:
Adults: 25 g IV initially, beginning after 24 hours of crystalloid administration. Adjust dose to maintain plasma albumin concentration of 2.5 g/100 mL or serum protein concentration of 5.2 g/100 mL (equivalent to a plasma oncotic pressure of 20 mmHg). Max: 2 g/kg/day. Duration of treatment is based on protein loss through renal excretion, denuded skin, and decreased albumin synthesis.
For the treatment of acute nephrosis in nephrotic syndrome:
Intravenous dosage (25% solution):
Adults: 25 g IV once daily for 7 to 10 days. Administer with an appropriate diuretic.
For treatment of hypoproteinemia:
Adults: 50 to 75 g IV initially. Consider the total body albumin deficit when determining the amount of albumin necessary. Calculate the body albumin compartment to be 80 to 100 mL/kg. Do not exceed 2 g/kg/day.
Children and Adolescents: 25 g IV initially. Consider the total body albumin deficit when determining the amount of albumin necessary. Calculate the body albumin compartment to be 80 to 100 mL/kg. Do not exceed a daily dose of 2 g/kg.
-for third space protein loss due to infection:
Adults: 50 to 100 g IV initially.
For adjunctive use with exchange transfusion in the treatment of hyperbilirubinemia and erythroblastosis fetalis (hemolytic disease of the newborn):
Intravenous dosage (25% solution):
Neonates: 1 g/kg/dose IV given approximately 1 hour prior to or during exchange transfusion.
For use during cardiopulmonary bypass surgery, including pump priming:
Adults: 25 g IV initially. May administer additional amounts as clinically indicated.
Infants, Children, and Adolescents: Preoperative dilution of blood using albumin and crystalloids can be used.
Adults: Adjust the albumin and crystalloid pump prime to achieve a hematocrit of 20% and a plasma albumin concentration of 2.5 g/100 mL in the patient.
Infants, Children, and Adolescents: Albumin may be used in the priming fluid.
For the treatment of acute respiratory distress syndrome (ARDS):
Intravenous dosage (25% solution):
Adults: 25 g IV every 8 hours for up to 3 days, if necessary.
For the prevention of central volume depletion after paracentesis due to ascites in hepatic cirrhosis:
Intravenous dosage (25% solution):
Adults: 8 g IV for every 1,000 mL of ascitic fluid removed.
Maximum Dosage Limits:
Individualize dosage based on careful monitoring of clinical parameters in all patient populations. In general, do not exceed 2 g/kg/day.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
There are no drug interactions associated with Albumin products.
Albumin is normally present in the blood and constitutes 50% to 60% of the plasma proteins and 80% to 85% of the oncotic pressure. Exogenously administered albumin increases the oncotic pressure of the intravascular system, pulling fluids from the interstitial space, thereby decreasing edema and increasing the circulating blood volume. This increase in volume reduces the concentration and viscosity of blood in patients with decreased circulating blood volume and also maintains cardiac output in shock. In dehydrated patients, albumin has little or no clinical effect on circulating blood volume. Albumin is also used to replace protein in patients with hypoproteinemia until the cause of the deficiency can be determined.
Albumin is administered intravenously as either a 5%, 20%, or 25% solution. It is distributed only in the intravascular space. Albumin solutions have a plasma half-life of 16 to 24 hours and a duration of volume expansion of 12 to 24 hours. Albumin 5% is osmotically equivalent to an equal volume of normal human plasma and will increase the circulating plasma volume by the amount equal to the volume infused. Albumin 25% solution will draw approximately 3.5 times the administered volume into the circulation within 15 minutes in adequately hydrated patients. The degree and duration of volume expansion depend on initial blood volume. When administered to patients with diminished blood volume, the effect of infused albumin may last for many hours; however, the duration is much shorter in patients with normal blood volume. In a 70-kg patient, total blood albumin is approximately 350 g. Albumin has a circulating life span of 15 to 20 days, with a turnover of approximately 15 g/day.
Affected cytochrome P450 isoenzymes and drug transporters: none