Albumin

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous:

Albumin-ZLB: 5% (250 mL, 500 mL); 25% (50 mL, 100 mL)

Albuminar-5: 5% (250 mL [DSC], 500 mL [DSC])

Albuminar-25: 25% (50 mL [DSC], 100 mL [DSC])

Albutein: 25% (50 mL, 100 mL)

Buminate: 5% (250 mL [DSC], 500 mL [DSC]); 25% (20 mL [DSC])

Plasbumin-5: 5% (50 mL [DSC], 250 mL [DSC])

Plasbumin-25: 25% (20 mL [DSC], 50 mL [DSC], 100 mL [DSC])

Generic: 25% (50 mL, 100 mL)

Solution, Intravenous [preservative free]:

Albuked 5: 5% (250 mL)

Albuked 25: 25% (50 mL, 100 mL)

Albuminex: 5% (250 mL, 500 mL); 25% (50 mL, 100 mL)

AlbuRx: 5% (250 mL, 500 mL)

Albutein: 5% (50 mL, 250 mL, 500 mL); 25% (20 mL, 50 mL, 100 mL)

Flexbumin: 5% (250 mL); 25% (50 mL, 100 mL)

Human Albumin Grifols: 25% (50 mL, 100 mL)

Kedbumin: 25% (50 mL, 100 mL)

Plasbumin-5: 5% (50 mL, 250 mL)

Plasbumin-25: 25% (20 mL, 50 mL, 100 mL)

Generic: 5% (100 mL, 250 mL, 500 mL); 25% (50 mL, 100 mL)

Pharmacology

Mechanism of Action

Provides increase in intravascular oncotic pressure and causes mobilization of fluids from interstitial into intravascular space

Pharmacokinetics/Pharmacodynamics

Half-Life Elimination

Half-life: 15 to 20 days

Use: Labeled Indications

Acute respiratory distress syndrome (25% solution only): To correct interstitial pulmonary edema and hypoproteinemia associated with acute respiratory distress syndrome in conjunction with diuretics.

Cirrhotic ascites, adjunct treatment: To maintain intravascular volume following removal of large-volume paracentesis in cirrhotic patients.

Erythrocyte resuspension: To avoid excessive hypoproteinemia, during certain types of exchange transfusion, or with the use of very large volumes or previously frozen or washed red cells.

Hypovolemia: Plasma volume expansion and maintenance of intravascular volume in the emergency treatment of hypovolemia (with or without shock).

Neonatal hemolytic disease: Binds and detoxifies unconjugated bilirubin in severe hemolytic disease of the newborn during exchange transfusion.

Nephrosis (acute), adjunct: Treatment of edema in patients with acute nephrosis in combination with diuretics.

Ovarian hyperstimulation syndrome, treatment (25% solution only): As a plasma volume expander in fluid management for the treatment of severe ovarian hyperstimulation syndrome.

Use: Off Label

Cirrhosis (in combination with diuretics to facilitate diuresis)byes

Data from an unblinded, randomized, controlled study supports the use of albumin in the treatment of cirrhosis (in combination with diuretics) to facilitate diuresis Romanelli 2006. Additional trials may be necessary to further define the role of albumin in this condition.

Based on the American Association for the Study of Liver Diseases (AASLD) guidelines for the management of adult patients with ascites due to cirrhosis, albumin given for cirrhosis (in combination with diuretics) to facilitate diuresis is possibly effective, but further studies are needed before albumin can be recommended for the management of this condition.

Spontaneous bacterial peritonitis (treatment)byes

American Association for the Study of Liver Diseases and European Association for the Study of the Liver clinical practice guidelines recommend albumin in conjunction with antibiotic therapy for treatment of cirrhotic patients with SBP. In controlled trials, the addition of albumin to antibiotic therapy was associated with significant reductions in incidences of renal impairment and mortality.

Volume expansion in dehydrated, mildly hypotensive patients with cirrhosisyes

Based on the American Association for the Study of Liver Diseases (AASLD) guidelines for the management of adult patients with ascites due to cirrhosis, albumin given for volume expansion in dehydrated, mildly hypotensive patients with cirrhosis is effective and recommended in the management of this condition.

Contraindications

Hypersensitivity to albumin or any component of the formulation; severe anemia, heart failure; patients at risk of volume overload (eg, patients with renal insufficiency, severe anemia, stabilized chronic anemia, or heart failure); dilution with sterile water for injection (may cause hemolysis or acute renal failure)

Dosage and Administration

Dosing: Adult

Note: Use 5% solution in hypovolemic patients or intravascularly depleted patients. Use 25% solution in patients in whom fluid and sodium intake is restricted or to mobilize fluids.

Usual dose: IV: 25 g; initial dose may be repeated in 15 to 30 minutes if response is inadequate.

Adult respiratory distress syndrome: IV: 25 g over 30 minutes (in combination with furosemide); may repeat at 8 hours (if necessary) for 3 days; titrate to fluid loss and normalization of serum total protein. Patients enrolled into the clinical trial had hypoproteinemia (total protein <6 g/dL) (Martin 2005).

Hypovolemia: 5% albumin: IV: Initial: 12.5 to 25 g (250 to 500 mL); repeat after 15 to 30 minutes as needed (if hemodynamic stability is not achieved). Note: May be considered after inadequate response to crystalloid therapy and when nonprotein colloids are contraindicated. The volume administered and the rate of infusion should be adapted to individual response.

Large-volume paracentesis: IV:

25% albumin: 5 to 10 g for every liter removed (usual dose cited: 8 g for every liter removed) (Bernardi 2012; Moore 2003; AASLD [Runyon 2012]) or 50 g total for paracentesis >5 L (ATS 2004). Note: Administer soon after the procedure to avoid postprocedural complications (eg, hypovolemia, hyponatremia, renal impairment) (Moore, 2003).

Manufacturer's labeling: Dosing in the prescribing information may not reflect current clinical practice. 25% albumin: 8 g for every liter removed.

Ovarian hyperstimulation syndrome (treatment): 25% albumin: IV: 50 to 100 g over 4 hours; repeat at 4 to 12 hours intervals as needed.

Plasma exchange: 5% albumin: IV: Titrate dose to plasma volume removed during procedure.

Spontaneous bacterial peritonitis (treatment) (off-label use): 25% albumin: IV: Initial: 1.5 g/kg within 6 hours of diagnosis (in conjunction with appropriate antimicrobial therapy), followed by 1 g/kg on day 3 (Abd 2012; AASLD [Runyon 2012]; Sort 1999). Note: Clinical trials used albumin 20%; the difference in concentration compared with 25% albumin is deemed to be clinically inconsequential.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Albumin 5% should be used in hypovolemic or intravascularly depleted patients; albumin 25% should be used in patients with fluid or sodium restrictions (eg, patients with hypoproteinemia and generalized edema, or nephrotic syndrome). Dose depends on condition of patient:

Ascites with hypoalbuminemia: Limited data available: Infants, Children, and Adolescents: 25% albumin: IV: 1 g/kg/dose over 2 to 3 hours; may repeat up to 3 times per day until albumin is >2.5 g/dL; maximum dose: 25 g/dose (Giefer 2011, Sabri 2003)

Hypovolemia, plasma volume expansion, including hypovolemic shock (SCCM [Dellinger 2013]): Infants, Children, and Adolescents: 5% albumin: IV: 0.5 to 1 g/kg/dose (10 to 20 mL/kg/dose) over 5 to 10 minutes. Usual adult dose: 12.5 to 25 g/dose (250 to 500 mL/dose). May repeat after 30 minutes if response is not adequate (Kleigman 2007).

Large volume paracentesis: Limited data available: Infants, Children, and Adolescents: 5% or 25% albumin: IV: 0.5 to 1 g/kg over 1 to 2 hours after paracentesis (Giefer 2011, Kramer 2001)

Nephrotic syndrome edema, refractory: Infants, Children, and Adolescents: 25% albumin: IV: 0.5 to 1 g/kg/dose over 30 to 60 minutes followed by diuretic therapy (Gipson 2009; Kliegman 2011; Robinson 2003)

Reconstitution

May dilute 25% albumin solutions with NS or D₅W. Do not use sterile water to dilute albumin solutions, as this has been associated with hypotonic-associated hemolysis. If 5% human albumin is unavailable, it may be prepared by diluting 25% human albumin with 0.9% sodium chloride or 5% dextrose in water.

Administration

For IV administration only. Infusion rate depends on indication and clinical situation. In emergencies, may administer as rapidly as necessary to improve clinical condition. After initial volume replacement:

5%: Do not exceed 2 to 4 mL/minute in patients with normal plasma volume; 5 to 10 mL/minute in patients with hypoproteinemia

25%: Do not exceed 1 mL/minute in patients with normal plasma volume; 2 to 3 mL/minute in patients with hypoproteinemia

Rapid infusion may cause vascular overload. Albumin 25% may be given undiluted or diluted in normal saline. May give in combination or through the same administration set as saline or carbohydrates. Warm to room temperature before use if large volumes are administered. Use within 4 hours after entering package; discard unused portion. Some products may require a filter; refer to product labeling. Do not use with ethanol or protein hydrolysates (precipitation may form).

Dietary Considerations

Some products may contain potassium and/or sodium.

Storage

Store at ≤30°C (86°F); do not freeze. Do not use solution if it is turbid or contains a deposit; use within 4 hours after opening vial; discard unused portion.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

Frequency not defined.

Cardiovascular: Cardiac failure (precipitation), edema, hypertension, hypotension, tachycardia

Central nervous system: Chills, headache

Dermatologic: Pruritus, skin rash, urticaria

Endocrine & metabolic: Hypervolemia

Gastrointestinal: Nausea, vomiting

Hypersensitivity: Anaphylaxis

Respiratory: Bronchospasm, pulmonary edema

Miscellaneous: Fever

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: Severe allergic or anaphylactic reaction may occur. Discontinue immediately and manage appropriately if allergic or anaphylactic reactions are suspected.
• Coagulation abnormality: Large replacement volumes may result in coagulation abnormality. Monitor and replete with blood constituents if indicated.
• Electrolyte imbalance: Large replacement volumes may result in electrolyte imbalance. Monitor electrolytes and replace or maintain as indicated.
• Hemodynamic effects: Cardiac or respiratory failure, renal failure, or increasing intracranial pressure can occur; closely monitor hemodynamic parameters in all patients.
• Hypervolemia/hemodilution: Use with caution in conditions where hypervolemia and its consequences or hemodilution may increase the risk of adverse effects (eg, heart failure, pulmonary edema, hypertension, hemorrhagic diathesis, esophageal varices). Adjust rate of administration per hemodynamic status and solution concentration; monitor closely with rapid infusions. Avoid rapid infusions in patients with a history of cardiovascular disease (may cause circulatory overload and pulmonary edema). Discontinue at the first signs of cardiovascular overload (eg, headache, dyspnea, jugular venous distention, rales, abnormal elevations in systemic or central venous blood pressure). All patients should be observed for signs of hypervolemia, such as pulmonary edema. Monitor blood pressure.

Disease-related concerns:

• Critical illness: In patients with increased microvascular permeability (eg, sepsis, trauma, burn), the translocation of fluid from the interstitial compartment to the intravascular compartment may decrease due to increased albumin in the interstitial space. Furthermore, in extreme microvascular permeability states, administration of albumin (or other colloids) may increase the net flux of fluid into the interstitial space reducing intravascular volume and precipitating edematous states (eg, pulmonary edema) (Roberts, 1998).
• Hepatic impairment: Use with caution in patients with hepatic impairment; protein load may exacerbate or precipitate encephalopathy.
• Renal impairment: Use with caution in patients with renal impairment; protein load may precipitate azotemia. Patients with chronic renal insufficiency receiving albumin solution may be at risk for accumulation of aluminum and potential toxicities (eg, hypercalcemia, vitamin D refractory osteodystrophy, anemia, severe progressive encephalopathy).

Special populations:

• Sodium restricted patients: Use with caution in those patients for whom sodium restriction is necessary. Albumin 5% and 25% solutions contain 130 to 160 mEq/L sodium and are considered isotonic with plasma.

Dosage form specific issues:

• Aluminum: The parenteral product may contain aluminum (Kelly, 1989); toxic aluminum concentrations may be seen with high doses, prolonged use, or renal dysfunction. Premature neonates are at higher risk due to immature renal function and aluminum intake from other parenteral sources. Parenteral aluminum exposure of >4 to 5 mcg/kg/day is associated with CNS and bone toxicity; tissue loading may occur at lower doses (Federal Register 2002). See manufacturer's labeling.
• Dilution: Do not dilute 5% albumin with sterile water for injection (may result in hemolysis and/or renal failure).
• Human plasma: Product of human plasma; may potentially contain infectious agents which could transmit disease. Screening of donors, as well as testing and/or inactivation or removal of certain viruses, reduces the risk. Infections thought to be transmitted by this product should be reported to the manufacturer.
• Latex: Packaging may contain natural latex rubber.

Monitoring Parameters

Monitor electrolytes, hemoglobin/hematocrit, and urine output regularly; monitor hemodynamic parameters, blood pressure, heart rate, central venous pressure, pulmonary artery occlusion pressure.

Pregnancy

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted.

Albumin is an endogenous substance; products are prepared from pooled human plasma. Available data are insufficient to recommend use of albumin to reduce the risk of ovarian hyperstimulation syndrome (Practice Committee 2016). Use for other indications may be considered in pregnant women when contraindications to nonprotein colloids exist (Liumbruno 2009).

Patient Education

What is this drug used for?

• It is used to treat or prevent low blood volume, to treat low blood pressure, to replace albumin in people with low blood albumin levels. It may be given for other reasons. Talk with doctor.

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, abnormal heartbeat, severe dizziness or passing out, fast heartbeat, increased thirst, seizures, loss of strength and energy, lack of appetite, unable to pass urine or change in amount of urine passed, dry mouth, dry eyes, or nausea or vomiting
• Dizziness
• Passing out
• Vision changes
• Headache
• Shortness of breath
• Excessive weight gain
• Swelling of arms or legs
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.