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Pronunciation

(al BYOO min)

Index Terms

  • Albumin (Human)
  • Normal Human Serum Albumin
  • Normal Serum Albumin (Human)
  • Salt Poor Albumin
  • SPA

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, 500 mL)

Albuminar-25: 25% (50 mL, 100 mL)

AlbuRx: 5% (250 mL, 500 mL)

Albutein: 25% (50 mL, 100 mL)

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

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

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

Generic: 5% (50 mL [DSC]); 25% (50 mL, 100 mL)

Solution, Intravenous [preservative free]:

Albuked 5: 5% (250 mL)

Albuked 25: 25% (50 mL, 100 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)

Brand Names: U.S.

  • Albuked 25
  • Albuked 5
  • Albumin - ZLB
  • Albuminar - 25
  • Albuminar - 5
  • AlbuRx
  • Albutein
  • Buminate
  • Flexbumin
  • Human Albumin Grifols
  • Kedbumin
  • Plasbumin-25
  • Plasbumin-5

Pharmacologic Category

  • Blood Product Derivative
  • Plasma Volume Expander, Colloid

Pharmacology

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

Half-Life Elimination

Half-life: 15 to 20 days

Use: Labeled Indications

Hypovolemia: Plasma volume expansion and maintenance of cardiac output in the treatment of certain types of shock or impending shock; adult respiratory distress syndrome (ARDS), acute/severe nephrosis, hemolytic disease of the newborn; cirrhotic ascites (prevention of central volume depletion after paracentesis); ovarian hyperstimulation syndrome (treatment); plasma volume exchange (replacement fluid); unless the condition responsible for hypoproteinemia can be corrected, albumin can provide only symptomatic relief or supportive treatment

Use: Unlabeled

In patients with cirrhosis, administered with diuretics to help facilitate diuresis; large volume paracentesis; volume expansion in dehydrated, mildly hypotensive patients with cirrhosis; to prevent renal impairment and reduce mortality associated with spontaneous bacterial peritonitis (SBP) in patients with cirrhosis

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)

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.

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 speed of infusion should be adapted to individual response.

Large-volume paracentesis: IV:

Manufacturer's labeling: 25% albumin: 8 g for every liter removed.

Alternate recommendations: 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).

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: 5% should be used in hypovolemic patients or intravascularly-depleted patients. 25% should be used in patients in whom fluid and sodium intake must be minimized.

Hemolytic disease of the newborn: Infants: IV: 1 g/kg/dose of 25% albumin prior to or during exchange transfusion

Hypovolemia:

Infants and Younger Children: IV: 0.5 to 1 g/kg/dose (10 to 20 mL/kg/dose of albumin 5%); repeat in 30 minute intervals as needed

Older Children and Adolescents: IV: 12.5 to 25 g (250 to 500 mL of albumin 5%); repeat in 30 minute intervals as needed.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

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.

Compatibility

Stable in dextran 6% in D5W, dextran 6% in NS, D5LR, D5NS, D51/2NS, D51/4NS, D5W, D10W, LR, NS, 1/2NS; incompatible with sterile water.

Y-site administration: Incompatible with fat emulsion (Intralipid), micafungin, midazolam, vancomycin, verapamil.

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: Congestive heart 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 Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted. Albumin may be used for the treatment of severe ovarian hyperstimulation syndrome when hypovolemia, hypotension, and oliguria are refractory to normal saline (ASRM 2008). Use for other indications may be considered in pregnant women when contraindications to nonprotein colloids exist (Liumbruno 2009).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber signs of fluid and electrolyte problems (mood changes, confusion, muscle pain or weakness, abnormal heartbeat, severe dizziness or passing out, tachycardia, increased thirst, seizures, loss of strength and energy, lack of appetite, urinary retention or change in amount of urine passed, dry mouth, dry eyes, or nausea or vomiting), headache, shortness of breath, excessive weight gain, or swelling of arms or legs (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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