Albutein (Intravenous)

Generic name: albumin human (intravenous route)
Drug class: Plasma expanders

Medically reviewed by Drugs.com. Last updated on Nov 9, 2022.

Commonly used brand name(s)

In the U.S.

• Albuked 25
• Albuked 5
• Albumarc
• Albuminar
• Alburx
• Albutein
• Buminate
• Flexbumin
• Kedbumin
• Plasbumin

Available Dosage Forms:

• Solution

Therapeutic Class: Volume Expander

Uses for Albutein

Albumin (human) injection is used to treat low blood volume (hypovolemia). It is also used to treat low albumin levels in the blood (hypoalbuminemia) caused by: not enough albumin produced by the body (eg, malnutrition, burns, major injury, infections), excessive breakdown of albumin (eg, burns, major injury, pancreatitis), loss of albumin from the body (eg, bleeding, excessive kidney excretion, burn exudates), or redistribution of albumin from the body (eg, major surgery, inflammatory conditions).

Albumin (human) injection is also used to treat hypoalbuminemia in patients with severe injuries, infections, or pancreatitis (swelling of the pancreas) that cannot be quickly reversed and when nutritional supplements have been given but did not work well. It is also used together with crystalloid treatment to correct lower osmotic pressure in the blood and to replace protein loss caused by severe burns after the first 24 hours.

Albumin (human) injection is used as a priming fluid during cardiopulmonary bypass surgery.

Flexbumin® 25% is used when hypovolemia is long-standing and hypoalbuminemia exists along with enough hydration, or fluid swelling (edema). It is also used together with other medicines (eg, water pill) to treat fluid swelling in the lungs (interstitial pulmonary edema) and hypoproteinemia (low protein levels in the blood) in patients with adult respiratory distress syndrome (ARDS). Flexbumin® 25% is also used to treat swelling in patients with severe nephrosis who are receiving steroids or a water pill. It is also used to treat hemolytic disease of the newborn (HDN) in babies.

This medicine is to be given only by or under the direct supervision of your doctor.

Before using Albutein

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of albumin (human) injection in children, given that the dose is appropriate for the body weight. Safety and efficacy have been established.

Geriatric

No information is available on the relationship of age to the effects of albumin (human) injection in geriatric patients.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to N-acetyltryptophan or sodium caprylate or
• Anemia, severe or
• Heart failure with normal or increased blood volume—Should not be used in patients with these conditions.

• Bleeding problems (eg, hemorrhagic diathesis) or
• Esophageal varices (extremely wide open veins in the esophagus that may cause bleeding) or
• Heart failure or
• Hypertension (high blood pressure) or
• Kidney failure or
• Pulmonary edema (fluid swelling in the lungs)—Use with caution. May increase the risk for hypervolemia or hemodilution (too much fluid in the blood).

Proper use of Albutein

This section provides information on the proper use of a number of products that contain albumin human. It may not be specific to Albutein. Please read with care.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a needle placed into one of your veins.

Precautions while using Albutein

It is very important that your doctor check your or your child''s progress closely while receiving the medicine to make sure it is working properly. Blood and urine tests are needed to check for unwanted effects.

This medicine may cause a serious allergic reaction, called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine may cause too much fluid in the blood (hypervolemia or hemodilution), which may lead to heart, blood vessel, or lung overload (swelling). Check with your doctor right away if you or your child has a headache, troubled breathing, chest pain or tightness, a bulging jugular vein, lightheadedness, or dizziness.

Check with your doctor right away if you or your child has bloody urine, blurred vision, change in the ability to see colors, especially blue or yellow, chest pain or discomfort, headache, irregular breathing or heartbeat, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, troubled breathing, unusual tiredness or weakness, or vomiting.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor if you have concerns about this risk.

Albutein side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Blue lips and fingernails
• chest pain
• cough
• coughing that sometimes produces a pink frothy sputum
• difficult, fast, noisy breathing
• difficulty swallowing
• dizziness
• fast heartbeat
• hives, itching, skin rash
• increased sweating
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• swelling in the legs and ankles
• tightness in the chest
• unusual tiredness or weakness

Incidence not known

• Blurred vision
• chest discomfort
• chills
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, pounding, or irregular heartbeat or pulse
• fever
• headache
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• sweating
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Feeling of warmth
• loss of or change in taste
• redness of the face, neck, arms, and occasionally, upper chest

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Albutein 25% Prescribing Information

Package insert / product label
Generic name: albumin (human)
Dosage form: injection
Drug class: Plasma expanders

Medically reviewed by Drugs.com. Last updated on Jun 21, 2022.

1. INDICATIONS AND USAGE

Albumin (Human) U.S.P., Albutein® 25% Solution is indicated:

1. For treatment of hypovolemic shock.1,2
2. As an adjunct in hemodialysis for patients undergoing long-term dialysis or for those patients who are fluid-overloaded and cannot tolerate substantial volumes of salt solution for therapy of shock or hypotension.3
3. In cardiopulmonary bypass procedures; however, the optimum regimen of fluids has not been established.

Conditions in which Albutein® 25% MAY BE indicated:

• Adult respiratory distress syndrome (ARDS).3,4
• Major injury or surgery resulting in increased albumin loss or inadequate synthesis.3,5
• Acute nephrosis not responding to cyclophosphamide or steroid therapy. Steroid therapy may increase edema which may respond to combined therapy of albumin with a diuretic.3
• Acute liver failure or ascites where the therapeutic use is regulated by the individual circumstances.3

Unless the pathologic condition responsible for hypoalbuminemia can be corrected, administration of albumin can afford only symptomatic relief. There is NO valid reason for the use of albumin as an intravenous nutrient.

2. DOSAGE AND ADMINISTRATION

Albutein® 25% is administered intravenously. The total dosage will vary with the individual. In adults, an initial infusion of 100 mL is suggested. Additional amounts may be administered as clinically indicated.

In the treatment of the patient in shock with greatly reduced blood volume, Albutein® 25% may be administered as rapidly as necessary in order to improve the clinical condition and restore normal blood volume. This may be repeated in 15-30 minutes if the initial dose fails to prove adequate. In the patient with a slightly low or normal blood volume, the rate of administration should be 1 mL per minute.

If dilution of Albutein® 25% is clinically desirable, compatible diluents include sterile 0.9% Sodium Chloride solution or sterile 5% Dextrose in Water.6

DIRECTIONS FOR USE: (50 mL and 100 mL)

When an Administration Set is Used

Flip off plastic cap on top of the vial and expose rubber stopper. Cleanse exposed rubber stopper with suitable germicidal solution, being sure to remove any excess. Observe aseptic technique and prepare sterile intravenous equipment as follows:

1. Close clamp on administration set.
2. With bottle upright, squeeze drip chamber, thrust piercing pin straight through stopper center. Do not twist or angle.
3. Immediately invert bottle, release drip chamber to automatically establish proper fluid level in drip chamber (half full).
4. Attach infusion set to administration set, open clamp and allow solution to expel air from tubing and needle, then close clamp.
5. Make venipuncture and adjust flow.
6. Discard all administration equipment after use. Discard any unused contents.

When an Administration Set is Not Used

Flip off plastic cap on top of the vial and expose rubber stopper. Cleanse exposed rubber stopper with suitable germicidal solution, being sure to remove any excess. Observe aseptic technique and prepare sterile intravenous equipment as follows:

1. Using aseptic technique, attach filter needle to a sterile disposable plastic syringe.
2. Insert filter needle into Albutein® 25%.
3. Aspirate Albutein® 25% from the vial into the syringe.
4. Remove and discard the filter needle from the syringe.
5. Attach desired size needle to syringe.
6. Discard all administration equipment after use. Discard any unused contents.

3. DOSAGE FORMS AND STRENGTHS

Albutein® 25% is a sterile, aqueous solution for single dose intravenous administration containing 25% human albumin (weight/volume). It is available in the following presentations:

• 12.5 g albumin/50 mL single dose vial.
• 25 g albumin/100 mL single dose vial.

4. CONTRAINDICATIONS

Albutein® 25% is contraindicated in patients with severe anemia or cardiac failure in the presence of normal or increased intravascular volume.

The use of Albutein® 25% is contraindicated in patients with a history of allergic reactions to albumin.

5. WARNINGS AND PRECAUTIONS

Warnings

Following reports that there exists a risk of potentially fatal hemolysis and acute renal failure from the inappropriate use of Sterile Water for Injection as a diluent for Albumin (Human)7, if dilution is required, acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water.6

Albutein® 25% is made from pooled human plasma. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases, including a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD). Although no cases of transmission of viral diseases or CJD have ever been identified for albumin, the risk of infectious agents cannot be totally eliminated. The physician should weigh the risks and benefits of the use of this product and should discuss these with the patient.

Solutions of Albutein® 25% should not be used if they appear turbid or if there is sediment in the bottle. Do not begin administration more than 4 hours after the container has been entered. Discard unused portion.

Precautions

Albutein® 25% should be administered with caution to patients with low cardiac reserve.

Rapid infusion may cause vascular overload with resultant pulmonary edema. Patients should be closely monitored for signs of increased venous pressure.

A rapid rise in blood pressure following infusion necessitates careful observation of injured or postoperative patients to detect and treat severed blood vessels that may not have bled at a lower pressure.

Patients with marked dehydration require administration of additional fluids. Albutein® 25% may be administered with the usual dextrose and saline intravenous solutions. However, certain solutions containing protein hydrolysates or alcohol must not be infused through the same administration set in conjunction with Albutein® 25% since these combinations may cause the proteins to precipitate. See also PATIENT COUNSELING INFORMATION (17).

6. ADVERSE REACTIONS

The most common adverse reactions include fever and chills, rash, nausea, vomiting, tachycardia and hypotension. Should an adverse reaction occur, slow or stop the infusion for a short period of time which may result in the disappearance of the symptoms. If administration has been stopped and the patient requires additional Albutein® 25%, material from a different lot should be used. Albutein® 25%, particularly if administered rapidly, may result in vascular overload with resultant pulmonary edema.

To report SUSPECTED ADVERSE REACTIONS, contact Grifols Biologicals Inc. at 1-888-GRIFOLS (1-888-474-3657) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

8. USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with Albutein® 25%. It is also not known whether Albutein® 25% can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Albutein® 25% should be given to a pregnant woman only if clearly needed.

Pediatric Use

Albutein® 25% is indicated in conjunction with exchange transfusion in the treatment of neonatal hyperbilirubinemia. The pediatric use of Albutein® 25% has not been clinically evaluated. The dosage will vary with the clinical state and body weight of the individual. Typically, a dose one-quarter to one-half the adult dose may be administered, or dosage may be calculated on the basis of 0.6 to 1.0 gram per kilogram of body weight (2.4 to 4 mL of Albutein® 25%). For jaundiced infants suffering from hemolytic disease of the newborn, the appropriate dose for binding of free serum bilirubin is 1 gram per kilogram of body weight which may be administered during the procedure.8 The usual rate of administration in children should be one-quarter the adult rate. Therefore, physicians should weigh the risks and benefits of the use of Albutein® 25% in the pediatric population.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

11. DESCRIPTION

Albutein® 25% is a sterile, aqueous solution for single dose intravenous administration containing 25% human albumin (weight/volume). Albutein® 25% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of albumin. Albutein® 25% is osmotically equivalent to five times its volume of normal human plasma. Albutein® 25% contains 130-160 milliequivalents of sodium ion per liter and has a pH of 7.0 ± 0.3. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives.

Albutein® 25% is heated at 60 °C for ten hours. No positive assertion can be made, however, that this heat treatment completely destroys the causative agents of viral hepatitis.

12. CLINICAL PHARMACOLOGY

Mechanism of Action

There are no known cases of viral hepatitis which have resulted from the administration of Albutein® 25%. Albumin is a highly soluble, globular protein (MW 66,500), accounting for 70-80% of the colloid osmotic pressure of plasma. Therefore, it is important in regulating the osmotic pressure of plasma.1,3 Albutein® 25% supplies the oncotic equivalent of approximately 5 times its volume of human plasma. It will increase the circulating plasma volume by an amount approximately 3.5 times the volume infused within 15 minutes, if the recipient is adequately hydrated.9 This extra fluid reduces hemoconcentration and decreases blood viscosity. The degree and duration of volume expansion depend upon the initial blood volume. When treating patients with diminished blood volume, the effect of infused albumin may persist for many hours. The hemodilution lasts for a shorter time when albumin is administered to individuals with normal blood volume.

Albumin is also a transport protein and binds naturally occurring, therapeutic, and toxic materials in the circulation.1

Albumin is distributed throughout the extracellular water and more than 60% of the body albumin pool is located in the extravascular fluid compartment. The total body albumin in a 70 kg man is approximately 320 g. Albumin has a circulating life span of 15-20 days, with a turnover of approximately 15 g per day.3

15. REFERENCES

1. Finlayson, J.S., Albumin Products Semin Thromb Hemo, 6:85-120, 1980.
2. Hauser, C.J., et. al., Oxygen Transport Responses to Colloids and Crystalloids in Critically Ill Surgical Patients, Surg Gyn Obs, 150:811-816, June 1980.
3. Tullis, J.L., Albumin: 1. Background and Use. 2. Guidelines for Clinical Use. JAMA 237:355-360, 460-463, 1977.
4. Shoemaker, W.C., et. al., Comparison of the Relative Effectiveness of Colloids and Crystalloids in Emergency Resuscitation, Am J Surg, 142:73-84, July 1981.
5. Peters, T., Jr., Serum Albumin in: The Plasma Proteins, 2nd Ed., Putnam F.W. (ed), New York, Academic Press, 1:133-181, 1975.
6. Albumin Human. In AHFS Drug Information, 1144-1146, 1998.
7. Data on File, FDA.
8. Tsao, Y.C., Yu, V.Y.H., Albumin in the Management of Neonatal Hyperbilirubinemia, Arch Dis Childhood, 47:250-256, 1972.
9. Janeway, C.A., Human Serum Albumin: Historical Review in Proceedings of the Workshop on Albumin, Sgouris, J.T. and Rene A. (eds), DHEW Publication No. (NIH) 76-925, Washington, D.C., U.S. Government Printing Office, 1976, pp. 3-21.

16. HOW SUPPLIED/STORAGE AND HANDLING

Albutein® 25% is supplied as a sterile, aqueous solution for single dose intravenous administration containing 25% human albumin (weight/volume). It is available in the following vial sizes:

• 50 mL vial Albutein® 25% (NDC 68516-5216-1).
• 100 mL vial Albutein® 25% (NDC 68516-5216-2).

Storage

Albutein® 25% is stable for three years provided that storage temperature does not exceed 30 °C. Protect from freezing.

17. PATIENT COUNSELING INFORMATION

The most common adverse reactions include fever and chills, rash, nausea, vomiting, tachycardia and hypotension. Depending on the severity of the reaction, patients should be advised to discontinue use of the product and contact their physician and/or seek immediate emergency care.

Albutein® 25% should be administered with caution to patients with low cardiac reserve.

Rapid infusion may cause vascular overload with resultant pulmonary edema. Patients should be closely monitored for signs of increased venous pressure.

A rapid rise in blood pressure following infusion necessitates careful observation of injured or postoperative patients to detect and treat severed blood vessels that may not have bled at a lower pressure.

Patients with marked dehydration require administration of additional fluids. Albutein® 25% may be administered with the usual dextrose and saline intravenous solutions. However, solutions containing protein hydrolysates or alcohol must not be infused through the same administration set in conjunction with Albutein® 25% since these combinations may cause the proteins to precipitate. See also WARNINGS AND PRECAUTIONS (5.2).

Manufactured and Distributed by:
Grifols Biologicals Inc.
Los Angeles, CA 90032, U.S.A.
U. S. License No. 1694
DATE OF REVISION: 07/2008

3028184

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 ML VIAL

GRIFOLS

NDC 68516-5216-1

Albumin (Human) U.S.P.

Albutein® 25%

25% 12.5 g 50 mL

Store at temperatures not exceeding 30 °C.

DO NOT USE IF TURBID. DO NOT BEGIN ADMINISTRATION MORE THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 100 ML VIAL

GRIFOLS

NDC 68516-5216-2

Albumin (Human) U.S.P.

Albutein® 25%

25% 25 g 100 mL

Store at temperatures not exceeding 30 °C.

DO NOT USE IF TURBID. DO NOT BEGIN ADMINISTRATION MORE THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 ML CARTON

GRIFOLS

NDC 68516-5214-1

Albumin (Human) U.S.P.

Albutein® 25%

Solution 12.5 g 50 mL

25%

Store at temperatures not exceeding 30 °C.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 100 ML CARTON

GRIFOLS

NDC 68516-5216-2

Albumin (Human) U.S.P.

Albutein® 25%

Solution 25 g 100 mL

25%

Store at temperatures not exceeding 30 °C.

Medical Disclaimer