Kedbumin (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 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 (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 for your doctor to monitor your or your child's progress closely while using this medicine to ensure it is working properly. Blood and urine tests are necessary to check for unwanted effects.

This medicine may cause a serious allergic reaction known as anaphylaxis, which can be life-threatening and requires 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 cause too much fluid in the blood (hypervolemia or hemodilution), which may lead to heart, blood vessel, or lung overload (swelling). Contact your doctor immediately if you or your child experiences a headache, troubled 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, a 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. 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, you and your doctor need to weigh the risks of taking it against the benefits it may provide. For this medicine, consider the following:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you have, including to foods, dyes, preservatives, or animals. For non-prescription products, check the label or package ingredients carefully.

Pediatric

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

Geriatric

There is no information available on how age affects the effects 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. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a chance of interaction. 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

Certain medicines should not be taken around mealtimes or with specific foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect 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—This medicine should not be used in these cases.

• Bleeding problems (e.g., hemorrhagic diathesis) or
• Esophageal varices (very enlarged veins in the esophagus that may cause bleeding) or
• Heart failure or
• Hypertension (high blood pressure) or
• Kidney failure or
• Pulmonary edema (fluid buildup in the lungs)—Use with caution. This may increase the risk for hypervolemia or hemodilution (too much fluid in the blood).

Along with its necessary effects, a medicine can cause some unwanted effects. While not all of these side effects may happen, if they do, they might require medical attention.

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

More common

• Blue lips and fingernails
• chest pain
• cough
• coughing that sometimes brings up 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 standing 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 require medical attention. These side effects may go away during treatment as your body adapts to the medicine. Your health care professional may also be able to tell you how to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, 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 sometimes, upper chest

Other side effects not listed may also happen 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

Find detailed information on biosimilars for this medication.

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.