AlbuRx

Name: AlbuRx

What Is Alburx?

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.

Albumin 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.

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

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

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

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

If possible before you receive albumin, 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.

Albumin 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.

FDA pregnancy category C. It is not known whether albumin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

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.

Uses of AlbuRx

  • It is used to treat or prevent low blood volume.
  • It is used to treat low blood pressure.
  • It is used to replace albumin in people with low blood albumin levels.
  • It is used to add back fluid after fluid loss.
  • It is used to treat shock.
  • It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take AlbuRx?

  • If you have an allergy to albumin, blood products, or any other part of AlbuRx (albumin).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have anemia or a weak heart.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take AlbuRx with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some other side effects of AlbuRx?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

How do I store and/or throw out AlbuRx?

  • If you need to store AlbuRx at home, talk with your doctor, nurse, or pharmacist about how to store it.

Description

AlbuRx® 5, Albumin (Human) 5% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood.

This product is prepared from the plasma of US donors. The product has been produced by alcohol fractionation and has been heated for 10 hours at 60°C for inactivation of infectious agents. The results of virus validation studies have shown that the manufacturing process, particularly alcohol fractionation, eliminates enveloped and non-enveloped viruses. Additionally, heat treatment at 60°C for a period of 10 hours efficiently inactivates viruses. The solution contains 130–160 milliequivalents of sodium per liter (mEq/L) and the potassium content is not over 2 mEq/L. The aluminum content does not exceed 200 µg/L. The solution is stabilized with 0.08 millimole of sodium acetyltryptophanate plus 0.08 millimole of sodium caprylate per gram of albumin. The solution contains no preservative.

Clinical pharmacology10,16

2.1 AlbuRx® 5, Albumin (Human) 5% solution should not be used as an intravenous nutrient because of the slow breakdown and relatively unfavorable composition of the albumin molecule with respect to its content of essential amino acids. Oral provision of proteins or an intravenous regimen providing adequate calories and a suitable amino acid mixture are the methods of choice for the treatment of protein malnutrition as such, though they do not permit the rapid correction of hypoproteinemia.

2.2 The binding properties of albumin may, in special circumstances, provide an indication for its clinical use. For such purposes, however, an Albumin (Human) 25% solution should be used.

2.3 The colloid osmotic or oncotic properties of albumin constitute the predominant reason for its clinical use. The rationale for this is the Starling concept of the capillary balance of hydrostatic and oncotic pressure gradients across the capillary walls as the determinant of the fluid – i.e. volume – distribution between the intravascular and the interstitial compartment15. The basic indication for the use of AlbuRx® 5, Albumin (Human) 5% solution is therefore a plasma or blood volume deficit. The 5% concentration is approximately isotonic and isooncotic with normal human plasma. The effective colloid osmotic pressure of the serum proteins depends very largely on the relatively small and numerous albumin molecules, which therefore play a decisive role in the maintenance of the circulating plasma volume.

Contraindications

The use of AlbuRx® 5, Albumin (Human) 5% solution is contraindicated in patients with a history of an incompatibility reaction to such preparations (see ADVERSE REACTIONS). In addition, AlbuRx® 5 may be contraindicated in patients with cardiac failure or severe anemia because of the risk of acute circulatory overload.

Package Label - Principal Display Panel - 250 mL

NDC 44206-310-25

5%

AlbuRx® 5
Albumin (Human)
5% Solution

250 mL

For intravenous
administration

Rx only

CSL Behring

(web3)