AlbuRx^® 5, AlbuRx^® 25

Albumin (Human) 5% Solution and 25% Solution

Q. What is AlbuRx^®?

A. AlbuRx^® is a plasma-derived protein used to treat patients who have a low volume of blood. It is primarily used in hospitals and often used for treating patients who have experienced major trauma, such as a car or industrial accident or stabbing, or for people who have lost blood during medical procedures, such as kidney dialysis.

Q. What other uses are there for AlbuRx^®?

A. AlbuRx^® can be used to replace naturally occurring albumin in people who have low amounts of the protein. This decrease in the plasma protein is known as hypoproteinemia. While AlbuRx^® 5 or 25 may be needed to treat acute complications of chronic hypoproteineimia, they are not indicated for treatment of the chronic condition itself.

Q. What causes hypoproteinemia?

A. The common causes of hypoproteinemia are protein malnutrition, poor absorption due to gastrointestinal disorders, low albumin production caused by chronic liver failure or the abnormal loss of albumin through chronic kidney disease.

Q. What are the possibilities of contracting blood-transmitted diseases from plasma-derived products?

A. CSL Behring and its predecessor companies have been manufacturing human blood-derived products for more than 25 years, giving us an extremely high level of expertise. Our manufacturing process has been fully approved by the FDA and we have one of the highest quality records in the industry. All blood and plasma donors are thoroughly screened prior to the collection of blood or plasma. Once collected, blood and plasma are tested using FDA-licensed tests to further check for the presence of viruses before the manufacturing process has even begun.

Q. Can AlbuRx^® 25 be diluted to a 5% solution?

A. AlbuRx^® 25 can be diluted to a 5% solution using either normal saline solution or 5% dextrose. (However, no albumin, including AlbuRx^® 25, should EVER be diluted with Sterile Water for Injection. Sterile water is NOT an appropriate diluent for albumin and could result in a hypo-osmolar solution, leading to adverse events and possibly death.) Using aseptic technique, we recommend you first add the diluent to a sterile pooling bag; then add the appropriate volume of AlbuRx^® 25 to achieve the final total volume needed. For example, 80 mL diluent plus 20 mL AlbuRx^® 25 will yield a final solution of 100 mL of albumin 5%.

Q. Can AlbuRx^® 25 be further diluted with sterile water?

A. No albumin, including AlbuRx^® 25, should EVER be diluted with Sterile Water for Injection. Sterile water is NOT an appropriate diluent for albumin and could result in a hypo-osmolar solution, leading to adverse events and possibly death. AlbuRx^® 25 should only be further diluted with either normal saline or 5% dextrose.

Q. What is the osmolarity of AlbuRx^® 5?

A. The osmolarity of AlbuRx^® 5 is 265 mOsm/kg.

Q. What is the osmolarity of AlbuRx^® 25?

A. The osmolarity of AlbuRx^® 25 is 269 mOsm/kg.

Q. Does AlbuRx^® have to be filtered?

A. AlbuRx^® does not have to be filtered.

Q. What is the risk of virus transmission with AlbuRx^®?

A. Since the introduction of Albumin over 50 years ago, there have been no confirmed reports of viral transmission. AlbuRx^® is pasteurized (heat treatment in aqueous solution) at 60°C for 10 hours. This viral inactivation process has demonstrated elimination of both lipid-enveloped and certain non-lipid-enveloped viruses in validation experiments. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Q. What information is available on the stability and compatibility of AlbuRx^® when mixed with other intravenous preparations?

A. CSL Behring has not conducted any studies on the stability and compatibility of AlbuRx^® when mixed with other intravenous preparations and, therefore, cannot recommend use of AlbuRx^® other than as a single-product infusion. Changes in pH or osmolarity are known to have the potential to denature or modify human serum albumin. Certain chemicals, such as antibiotics, nutrients, or electrolytes in high concentration could cause albumin to aggregate in solution intended for intravenous administration.

Important Safety Information

The use of AlbuRx^® 5 and 25 is contraindicated in patients with a history of an incompatibility reaction to albumin (human). In addition, AlbuRx^® 5 may be contraindicated in patients with cardiac failure or severe anemia because of the risk of acute circulatory overload.

Though very rare, non-septic incompatibility reactions including nausea, chills, fever, urticaria, headache, and hypotension following the administration of albumin-containing preparations have occasionally been observed.

AlbuRx^® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob (CJD) disease agent, cannot be completely eliminated.