Serum albumin

Serum albumin
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

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Overview

Serum albumin is a volume expander that is FDA approved for the treatment of burn therapy, Cardiopulmonary bypass, hypovolemic shock, acute liver failure and sequestration of protein rich fluids. Common adverse reactions include {{{adverseReactions}}}.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Emergency Treatment of Hypovolemic Shock

Albuked 5 is iso-oncotic with normal plasma and on intravenous infusion will expand the circulating blood volume by an amount approximately equal to the volume infused. In conditions associated mainly with a volume deficit, albumin is best administered as a 5% solution (Albuked 5); but where there is an oncotic deficit, Albumin (Human) 25%, USP (Albuked™ 25) may be preferred. This is also an important consideration where the treatment of the shock state has been delayed. If Albuked 25 is used, appropriate additional crystalloid should be administered.

Crystalloid solutions in volumes several times greater than that of Albuked 5 may be effective in treating shock in younger individuals who have no preexisting illness at the time of the incident. Older patients, especially those with preexisting debilitating conditions, or those in whom the shock is caused by a medical disorder, or where the state of shock has existed for some time before active therapy could be instituted, may not tolerate hypoalbuminemia as well.

Removal of ascitic fluid from a patient with cirrhosis may cause changes in cardiovascular function and even result in hypovolemic shock. In such circumstances, the use of albumin infusion may be required to support the blood volume.

Burn Therapy

An optimal therapeutic regimen with respect to the administration of colloids, crystalloids, and water following extensive burns has not been established. During the first 24 hours after sustaining thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. Beyond 24 hours, albumin can be used to maintain plasma colloid osmotic pressure. Albuked 25 may be preferred for this purpose.

Cardiopulmonary Bypass

With the relatively small priming volume required with modern pumps, preoperative dilution of the blood using albumin and crystalloid has been shown to be safe and well-tolerated. Although the limit to which the hematocrit and plasma protein concentration can be safely lowered has not been defined, it is common practice to adjust the albumin and crystalloid pump prime to achieve a hematocrit of 20% and a plasma albumin concentration of 2.5 g per 100 mL in the patient.

Acute Liver Failure

In the uncommon situation of rapid loss of liver function, with or without coma, administration of albumin may serve the double purpose of supporting the colloid osmotic pressure of the plasma as well as binding excess plasma bilirubin.

Sequestration of Protein Rich Fluids

This occurs in such conditions as acute peritonitis, pancreatitis, mediastinitis, and extensive cellulitis. The magnitude of loss into the third space may require treatment of reduced volume or oncotic activity with an infusion of albumin.

Hypoproteinemia With or Without Edema

During major surgery, patients can lose over half of their circulating albumin with the attendant complications of oncotic deficit. A similar situation can occur in sepsis or intensive care patients. Treatment with Albuked 25 may be of value in such cases.

Acute Respiratory Distress Syndrome

This is characterized by deficient oxygenation caused by pulmonary interstitial edema complicating shock and postsurgical conditions. When clinical signs are those of hypoproteinemia with a fluid volume overload, Albuked 25 together with a diuretic may play a role in therapy.

Neonatal Hemolytic Disease

The administration of Albuked 25 may be indicated prior to exchange transfusion, in order to bind free bilirubin, thus lessening the risk of kernicterus. A dosage of 1 g /kg body weight is given about 1 hour prior to exchange transfusion. Caution must be observed in hypervolemic infants.

Acute Nephrosis

Certain patients may not respond to cyclophosphamide or steroid therapy. The steroids may even aggravate the underlying edema. In this situation a loop diuretic and 100 mL Albuked 25 repeated daily for 7 to 10 days may be helpful in controlling the edema and the patient may then respond to steroid treatment.

Renal Dialysis

Although not part of the regular regimen of renal dialysis, Albuked 25 may be of value in the treatment of shock or hypotension in these patients. The usual volume administered is about 100 mL, taking particular care to avoid fluid overload as these patients are often fluid overloaded and cannot tolerate substantial volumes of salt solution.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Serum albumin in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Serum albumin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Serum albumin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Serum albumin in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Serum albumin in pediatric patients.

Contraindications

Certain patients, e.g., those with a history of congestive cardiac failure, renal insufficiency or stabilized chronic anemia, are at special risk of developing circulatory overload. A history of allergic reaction to albumin is a specific contraindication for usage.

Warnings

Albuked 5 is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob Disease (CJD) agent that can cause disease. The theoretical risk for transmission of CJD is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Grifols Therapeutics Inc. [1-800-520-2807].The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient.

Solutions which have been frozen should not be used. Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered. Partially used vials must be discarded. Vials which are cracked or which have been previously entered or damaged should not be used, as this may have allowed the entry of microorganisms. Albumin (Human) 5%, USP (Albuked™ 5) contains no preservative.

Adverse Reactions

Clinical Trials Experience

Adverse reactions to albumin are rare. Such reactions may be allergic in nature or be due to high plasma protein levels from excessive albumin administration. Allergic manifestations include urticaria, chills, fever, and changes in respiration, pulse and blood pressure.

Postmarketing Experience

There is limited information regarding Serum albumin Postmarketing Experience in the drug label.

Drug Interactions

Albuked 5 is compatible with whole blood and packed red cells, as well as the standard carbohydrate and electrolyte solutions intended for intravenous use. It should not be mixed with protein hydrolysates, amino acid solutions nor those containing alcohol.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C Animal reproduction studies have not been conducted with Albuked 5. It is also not known whether Albuked 5 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Albuked 5 should be given to a pregnant woman only if clearly needed.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Serum albumin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Serum albumin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Serum albumin in women who are nursing.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

Geriatic Use

There is no FDA guidance on the use of Serum albumin in geriatric settings.

Gender

There is no FDA guidance on the use of Serum albumin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Serum albumin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Serum albumin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Serum albumin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Serum albumin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Serum albumin in patients who are immunocompromised.

Administration and Monitoring

Administration

Albuked 5 should always be administered by intravenous infusion.

Monitoring

There is limited information regarding Serum albumin Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Serum albumin and IV administrations.

Overdosage

There is limited information regarding Serum albumin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

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Mechanism of Action

There is limited information regarding Serum albumin Mechanism of Action in the drug label.

Structure

There is limited information regarding Serum albumin Structure in the drug label.

Pharmacodynamics

There is limited information regarding Serum albumin Pharmacodynamics in the drug label.

Pharmacokinetics

When administered intravenously to an adequately hydrated subject, the oncotic (colloid osmotic) effect of Albuked 5 is to expand the circulating blood volume by an amount approximately equal to the volume infused. It is primarily used in the treatment of shock associated with hemorrhage, surgery, trauma, burns, bacteremia, renal failure, and cardiovascular collapse.

Albumin is a transport protein and it may be useful in severe jaundice in hemolytic disease of the newborn. This could also be of importance in acute liver failure where albumin might serve the dual role of supporting plasma oncotic pressure, as well as binding excessive plasma bilirubin.(1)

Nonclinical Toxicology

There is limited information regarding Serum albumin Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Serum albumin Clinical Studies in the drug label.

How Supplied

Albuked 5 is available in 50 mL and 250 mL rubber-stoppered vials. Each single dose vial contains albumin in the following approximate amounts:

Storage

Store at room temperature not exceeding 30°C (86°F). Do not freeze. Do not use after expiration date.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Serum albumin Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Serum albumin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• Albumarc
• Albuminar
• Alburx
• Albutein
• Buminate
• Flexbumin
• Plasbumin
• Kedbumin

Look-Alike Drug Names

There is limited information regarding Serum albumin Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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