Pronunciation:

al-BUE-min HUE-man

Brand Names:

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

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Volume Expander

Uses of This Medicine:

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 This Medicine:

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.

Children—

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.

Older adults—

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

Breast-feeding—

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.

Other 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.

Other interactions—

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 This Medicine:

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 This Medicine:

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.

Side Effects of This Medicine:

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.