Albumarc (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 Albumarc

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 Albumarc

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 Albumarc

This section provides information on the proper use of a number of products that contain albumin human. It may not be specific to Albumarc. 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 Albumarc

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.

Albumarc 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

Package insert / product label
Dosage form: injection
Drug class: Plasma expanders

Medically reviewed by Drugs.com. Last updated on Jul 22, 2022.

Indications and Usage for Albumin (Human) 20%

Hypovolemia

Albumin (Human) 20% is indicated in the emergency treatment of hypovolemia with or without shock. Its effectiveness in reversing hypovolemia depends largely upon its ability to draw interstitial fluid into the circulation. It is most effective in patients who are well hydrated. When blood volume deficit is the result of hemorrhage, compatible red blood cells or whole blood should be administered as quickly as possible. [1, 2]

When hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20% - 25% albumin solutions should be used. [ 1 ]

Hypoalbuminemia

For subjects with hypoalbuminemia who are critically ill and/or are bleeding actively, ALBUMIN (HUMAN) 20% infusions may be indicated. [ 3 ] When albumin deficit is the result of excessive protein loss, the effect of administration of Albumin (Human) 20% will be temporary unless the underlying disorder is reversed.

Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites (Treatment Adjunct)

Albumin (Human) 20% may be used to maintain cardiovascular function following the removal of large volumes of ascitic fluid after paracentesis due to cirrhotic ascites. [ 2 ]

Ovarian Hyperstimulation Syndrome (OHSS)

Albumin (Human) 20% may be used as a plasma expander in fluid management relating to severe forms of ovarian hyperstimulation syndrome (OHSS). [7, 8]

Adult Respiratory Distress Syndrome (ARDS) (Treatment Adjunct)

Albumin (Human) 20% infusions may be indicated in conjunction with diuretics to correct the fluid volume overload associated with ARDS. [ 5 ]

Acute Nephrosis (Treatment Adjunct)

Albumin (Human) 20% may be used to treat edema in patients with acute nephrosis who are refractory to cyclophosphamide and corticosteroid therapy. [ 1 ]

Hemolytic Disease of the Newborn (HDN)

Albumin (Human) 20% is indicated in the treatment of hyperbilirubinemia. It may be used prior to or during an exchange procedure in an attempt to bind free and to enhance its removal. [ 6 ]

Albumin (Human) 20% Dosage and Administration

Dosage

General Recommendations

The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patient’s individual requirements.

The dose required depends on the body weight of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required.

The daily dose should not exceed 2 g of Albumin (Human) 20% per kg of body weight.

Hypovolemia

In adults, an intravenous infusion of 25 g should be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.

In spite of limited information about the efficacy in pediatric subjects, an intravenous infusion of 2.5 to 12.5 g or 0.5 to 1 g/kg body weight may be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.

Hemodilution may follow administration of Albumin (Human) 20%. If hemorrhage has occurred, this may result in relative anemia. This condition should be controlled by the supplemental administration of compatible red blood cells or compatible whole blood.

Hypoalbuminemia

In adults, intravenous infusion of 50 to 75 g of Albumin (Human) 20% may be used. Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoalbuminemia.

In burns, therapy usually starts with the administration of large volumes of crystalloid injection to maintain plasma volume. After 24 hours, Albumin (Human) 20% may be added at an initial dose of 25 g with the dose adjusted thereafter to maintain a plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g/100 mL.

Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites

In adults, intravenous infusion of 8 g of Albumin (Human) 20% may be given for every 1,000 mL of ascitic fluid removed.

Ovarian Hyperstimulation Syndrome

In adults, as a guideline, doses of 50 – 100 g of Albumin (Human) 20% should be infused over 4 hours and repeated at 4- to 12-hour intervals as necessary, when infusion of normal saline fails to achieve or maintain hemodynamic stability and urine output. [ 7 ]

Adult Respiratory Distress Syndrome (ARDS)

In adults, a dose of 25 g of Albumin (Human) 20% can be infused over 30 minutes and repeated at 8 hour intervals for 3 days, if necessary. [ 5 ]

Induction of Diuresis in Patients with Acute Nephrosis

In adults, a dose of 25 g of Albumin (Human) 20% can be infused, administered with an appropriate diuretic once a day for 7 to 10 days.

Hemolytic Disease of the Newborn

In newborns, Albumin (Human) 20% may be administered prior to or during exchange transfusion at a dose of 1 g per kilogram body weight. [ 6 ]

Administration

Intravenous use only.

Prior to administration, parenteral drug products should be inspected visually for turbidity and discoloration, whenever solution and container permit.

Do not dilute with sterile water for injection.

Do not use solutions of Albumin (Human) 20% which are cloudy or have deposits. Once the infusion container has been opened the contents should be used immediately. Discard the unused portion. Filtration of Albumin (Human) 20% is not required.

The infusion rate should be adjusted according to the individual circumstances and the indication. In plasma exchange during paracentesis, the infusion rate may be higher and should be adjusted to the rate of removal.

If large volumes (greater than 1500 ml) are administered, the product should be warmed to room temperature before use.

Dosage Forms and Strengths

Albumin (Human) 20% is supplied in

• 10 g in 50 mL infusion bottle
• 20 g in 100 mL infusion bottle

Contraindications

Do not use in individuals who are hypersensitive to albumin preparations, any ingredient in the formulation, or components of the container.

Warnings and Precautions

Hypersensitivity

Hypersensitivity or allergic reactions have been observed, and may in some cases progress to severe anaphylaxis. Epinephrine should be available immediately to treat any acute hypersensitivity reaction.

Hypervolemia/Hemodilution

Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the patient’s volume status. At the first clinical signs of possible cardiovascular overload, e.g., headache, dyspnea, increased blood pressure, jugular venous distention, elevated central venous pressure, pulmonary edema, the infusion should be stopped immediately and the patient reevaluated. Albumin should be used with caution in conditions where hypervolemia and its consequences or hemodilution could represent a special risk for the patient. Examples of such conditions are:

• Decompensated cardiac insufficiency
• Hypertension
• Esophageal varices
• Pulmonary edema
• Hemorrhagic diathesis
• Severe anemia
• Renal and post-renal anuria.

Electrolyte Imbalance

20-25% Albumin (Human) is relatively low in electrolytes compared to the 4-5% Albumin (Human) solutions. When albumin is given, monitor the electrolyte status of the patient and take appropriate steps to restore or maintain the electrolyte balance.

Coagulation Abnormalities

If comparatively large volumes are to be replaced, monitoring of coagulation and hematocrit is necessary. Ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets and erythrocytes).

Laboratory Monitoring

If Albumin (Human) 20% is to be administered, monitor hemodynamic performance regularly; this may include:

• Arterial blood pressure and pulse rate
• Central venous pressure
• Pulmonary artery occlusion pressure
• Urine output
• Electrolytes
• Hematocrit/hemoglobin.

Application Precautions

Albumin (Human) 20% must not be diluted with sterile water for injection as this may cause hemolysis in recipients.

Infection Risk from Human Plasma

This product is a derivative of human plasma. Based on effective donor screening and product manufacturing processes it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob Disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have been identified for Albumin (Human) 20%.

Adverse Reactions

General

The most serious events are anaphylactic shock, circulatory failure, cardiac failure, and pulmonary edema.

The most common adverse events are anaphylactoid type of reactions.

Adverse reactions for Albumin (Human) 20% normally resolve when the infusion rate is slowed down or the infusion is stopped. In case of severe reactions, the infusion should be stopped and appropriate treatment should be initiated.

Clinical Studies Experience

No clinical studies were done using Albumin (Human) 20%

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ALBUMIN (HUMAN) (any strength). Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency.

Table 1 Adverse reactions observed for ALBUMIN HUMAN (any strength) during post-marketing phase (in decreasing order of severity)

No drug interaction studies have been conducted.

Drug Interactions

No drug interaction studies have been conducted.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been performed with Albumin (Human) 20%. It is also not known whether Albumin (Human) 20% can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Albumin (Human) 20% should be given to a pregnant woman only if necessary.

Labor and Delivery

It is also not known whether Albumin (Human) 20% can cause fetal harm when administered to a woman during labor or delivery of if it will affect reproductive capacity. Albumin (Human) 20% should be given during labor or delivery only if necessary.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Albumin (Human) 20% should be given to nursing mothers only if necessary. Because many drugs are excreted in human milk, caution should be exercised when Albumin (Human) 20% is administered to a lactating woman.

Pediatric Use

Data on the use of Albumin (Human) 20% in children including premature babies are very limited. The product should be administered to pediatric patients only if needed.

Geriatric Use

Clinical studies did not include a sufficient number of subjects aged 65 and older to determine whether they respond differently from younger subjects.

Albumin (Human) 20% Description

Albumin (Human) 20% is a sterile, liquid preparation of albumin derived from large pools of human plasma. All units of human plasma used in the manufacture of Albumin (Human) 20% are provided by FDA approved blood establishments only.

The product is manufactured by cold ethanol fractionation followed by ultra- and diafiltration. The manufacturing process includes final container pasteurization and additional bulk pasteurization at 60 +/- 0.5°C for 10 – 11 hours. The Albumin (Human) 20% manufacturing process provides a significant viral reduction in in vitro studies (table 2). These reductions are achieved through a combination of process steps including Cohn fractionation and final container pasteurization.

No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma.[see Warnings and Precautions, Infection Risk from Human Plasma (5.7)]

Table 2 In vitro reduction factor during Albumin (Human) 20% manufacturing

PRV:Pseudorabies Virus

SBV: Sindbis Virus

HIV-1:Human Immunodeficiency Virus - 1

Reo 3:Reovirus Type 3

PPV:Porcine Parvovirus

HAV:Hepatitis A Virus

Albumin (Human) 20% is a clear, slightly viscous liquid; it is almost colorless or slightly yellow or green.

The composition of Albumin (Human) 20% is as follows:

Albumin (Human) 20% contains no preservatives and components used in its packaging are latex-free.

Albumin (Human) 20% - Clinical Pharmacology

No pharmacokinetic or pharmacodynamic studies with Albumin (Human) 20% have been conducted.

Mechanism of Action

Albumin is responsible for 75-80% of the colloid osmotic pressure of normal plasma. Albumin stabilizes circulating blood volume and is a carrier of hormones, enzymes, medicinal products and toxins. [ 3 ]

Albumin is a protein with a total extravascular mass of approximately 160 g and an intravascular mass of about 120 g. [ 3 ]

Pharmacodynamics

The colloid osmotic effect of Albumin (Human) 20% and 25% is approximately 5 times the volume administered. When injected intravenously, it will increase circulating plasma volume by approximately 3.5 times the volume infused within 15 minutes if the patient is adequately hydrated. This extra fluid reduces hemoconcentration and blood viscosity. The degree and duration of volume expansion depends 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. [ 4 ]

NON-CLINICAL TOXICOLOGY

No non-clinical toxicology studies with Albumin (Human) 20% have been conducted. Human Albumin is a normal constituent of human plasma and acts like physiological albumin.

Clinical Studies

No clinical studies with Albumin (Human) 20% have been conducted.

REFERENCES

1. Tullis JL: Albumin 2.Guidelines for Clinical Use. JAMA 1977; 237:460-463
2. Vermeulen LC et al.: A Paradigm for Consensus. Arch. Intern. Med. 1995; 155:373-379
3. Mendez CM, McClain CJ, Marsano LS: Albumin Therapy in Clinical Practice. Nutrition in Clinical Practice 2005; 20: 314-320
4. Janeway, C. A. "Human Serum Albumin: Historical Review" in: Proceedings of the Workshop on Albumin. DHEW Publication No. (NIH) 76-925. Sgouris, J. T. and René A. (eds.), Washington, D.C., U.S. Government Printing Office. 1976, pp 3-21.
5. Martin GS et al.: A randomized, controlled trail of furosemide with or without albumin in hypoproteinemic patients with acute lung injury. Crit. Care Med. 2005; 33: 1681-1687
6. Tsao YC, Yu VY: Albumin in management of neonatal hyperbilirubinaemia. Arch Dis.Child 1972;47:250-256.
7. Practice Committee of the American Society for Reproductive Medicine. Ovarian hyperstimulation syndrome. Fertil.Steril. 2006;86:S178-S183.
8. Aboulghar M, Evers JH, Al Inany H: Intravenous albumin for preventing severe ovarian hyperstimulation syndrome: a Cochrane review. Hum.Reprod. 2002;17:3027-3032.

How Supplied/Storage and Handling

Albumin (Human) 20% is supplied in 10 g in 50 mL or 20 g in 100 mL single use bottles.

Albumin (Human) 20% may be stored for 36 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture.

Store protected from light.

Do not freeze.

Do not use after expiration date.

Do not use if turbid.

Patient Counseling Information

Information for Patients

This product is usually given in a hospital setting.

Inform patients being treated with Albumin (Human) 20% about the potential risks and benefits with its use [see Adverse Reactions (6)].

Discontinue immediately if allergic symptoms occur (e.g. skin rashes, hives, itching, breathing difficulties, coughing, nausea, vomiting, fall in blood pressure, increased heart rate).

Inform patients that Albumin (Human) 20% is a derivative of human plasma and may contain infectious agents that cause disease (e.g., viruses, and theoretically, CJD agent). Inform patients that the risk that Albumin (Human) 20% may transmit an infections agent has been reduced by screening plasma donors for prior exposure for certain viruses, by testing the donated plasma for certain virus infections and by inactivating and/or removing certain viruses during manufacturing [see Warnings and Precautions (5.7)].

Manufactured by:

Octapharma Pharmazeutika Produktionsges.m.b.H.

Oberlaaer Strasse 235

A-1100 Vienna, Austria

Octapharma AB

Elersvägen 40

SE- 112 75, Sweden

U.S. License No. 1646

Distributed by:

Octapharma USA Inc.

121 River Street, 12 th floor

Hoboken, NJ 07030

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

Albumin (Human) 20%

10 g in 50 mL

Octapharma Pharmazeutika Produktionsges.m.b.H

NDC 67467-633-01

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

Albumin (Human) 20%

20 g in 100 mL

Octapharma Pharmazeutika Produktionsges.m.b.H

NDC 67467-633-02

Medical Disclaimer