Plasbumin (Intravenous)

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 (for example, malnutrition, burns, major injury, infections), excessive breakdown of albumin (for example, burns, major injury, pancreatitis), loss of albumin from the body (for example, bleeding, excessive kidney excretion, burn exudates), or redistribution of albumin from the body (for example, 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 along with crystalloid treatment to correct lower osmotic pressure in the blood and to replace protein loss from 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 with other medicines (for example, 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.

It is very important that your doctor monitor your or your child's progress closely while using this medicine to ensure it is effective. Blood and urine tests are required to check for any unwanted effects.

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

This medicine may lead to too much fluid in the blood (hypervolemia or hemodilution), which can result in overload (swelling) of the heart, blood vessels, or lungs. Contact your doctor immediately if you or your child has a headache, trouble breathing, chest pain or tightness, a bulging jugular vein, lightheadedness, or dizziness.

Contact your doctor immediately if you or your child has bloody urine, blurred vision, changes in color vision, 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, trouble 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 received them, although the risk is low. Both human donors and donated blood are tested for viruses to minimize the transmission risk. Discuss any concerns you have about this risk with your doctor.

In deciding to use a medicine, it's important to consider the risks against the benefits. This is a decision for you and your doctor. For this medicine, keep the following in mind:

Allergies

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

Pediatric

Studies have not shown any specific problems that would limit the usefulness of albumin (human) injection in children, as long as the dose is appropriate for their body weight. Safety and effectiveness have been established.

Geriatric

There is no information available about how age affects the use of albumin (human) injection in older patients.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction might happen. In such cases, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. Discuss with your healthcare professional how your medicine interacts with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may impact the use of this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

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

• Bleeding problems (e.g., hemorrhagic diathesis) or
• Esophageal varices (very 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).

Along with its desired effects, a medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, they may require medical attention.

Contact your doctor or nurse right away if you experience any of the following side effects:

More common

• Blue lips and fingernails
• Chest pain
• Cough
• Coughing that sometimes produces a pink frothy sputum
• Difficulty breathing that is fast, noisy, or hard
• Trouble 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 standing up suddenly from lying or sitting
• 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 happen that usually do not require medical attention. These side effects may go away as your body adjusts to the medicine. Your healthcare professional may also know ways to prevent or lessen some of these side effects. Talk to your healthcare professional if any of the following side effects persist, are bothersome, or if you have any questions about them:

Incidence not known

• Feeling of warmth
• Change or loss of taste
• Redness of the face, neck, arms, and sometimes, upper chest

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

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

In the U.S.

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

Available Dosage Forms:

• Solution

Therapeutic Class: Volume Expander

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.