Flexbumin is an injection containg albumin. Albumin is a protein produced by the liver that circulates in plasma (the clear liquid portion of your blood). Medicinal albumin is made of plasma proteins from human blood. This medicine works by increasing plasma volume or levels of albumin in the blood.

Flexbumin is used to replace blood volume loss resulting from trauma such as a severe burns or an injury that causes blood loss. This medicine is also used to treat low albumin levels caused by surgery, dialysis, abdominal infections, liver failure, pancreatitis, respiratory distress, bypass surgery, ovarian problems caused by fertility drugs, and other many other conditions.

Flexbumin may also be used for purposes not listed in this medication guide.

You should not receive Flexbumin if you have severe anemia (lack of red blood cells), or severe heart failure.

Before taking this medicine

You should not use Flexbumin if you are allergic to albumin, or if you have:

• severe anemia (lack of red blood cells); or

• severe heart failure.

If possible before you receive Flexbumin, tell your doctor if you have:

• anemia;

• heart disease, high blood pressure;

• bleeding or blood clotting disorder such as hemophilia;

• lung problems;

• kidney disease;

• a latex allergy; or

• if you are unable to urinate.

In an emergency situation it may not be possible to tell your caregivers about your health conditions. Make sure any doctor caring for you afterward knows you have received this medicine.

Flexbumin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

It is not known whether Flexbumin will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether albumin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

In an emergency situation it may not be possible to tell your caregivers if you are pregnant or breast feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication.

Flexbumin is injected into a vein through an IV. A healthcare provider will give you this injection.

Your breathing, pulse, blood pressure, electrolyte levels, kidney function, and other vital signs will be watched closely while you are receiving Flexbumin. Your blood will also need to be tested regularly during treatment.

Drink plenty of liquids while you are being treated with Flexbumin.

You should not use Flexbumin if you are allergic to albumin, or if you have:

• severe anemia (lack of red blood cells); or

• severe heart failure.

If possible before you receive Flexbumin, tell your doctor if you have:

• anemia;

• heart disease, high blood pressure;

• bleeding or blood clotting disorder such as hemophilia;

• lung problems;

• kidney disease;

• a latex allergy; or

• if you are unable to urinate.

In an emergency situation it may not be possible to tell your caregivers about your health conditions. Make sure any doctor caring for you afterward knows you have received this medicine.

Flexbumin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

It is not known whether Flexbumin will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether albumin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

In an emergency situation it may not be possible to tell your caregivers if you are pregnant or breast feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication.

Because you will receive Flexbumin in a clinical setting, you are not likely to miss a dose.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Flexbumin: hives; cough, difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregiver right away if you have:

• a light-headed feeling, like you might pass out;

• weak or shallow breathing;

• throbbing headache, blurred vision, buzzing in your ears;

• anxiety, confusion, sweating, pale skin; or

• severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, chest pain, and fast or uneven heart rate.

Common Flexbumin side effects may include:

• nausea, vomiting;

• fever, chills;

• fast heart rate;

• mild rash; or

• flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.