Albutein 25%

Albumin (Human) U.S.P., Albutein® 25% Solution is indicated:

1. For treatment of hypovolemic shock.1,2
2. As an adjunct in hemodialysis for patients undergoing long-term dialysis or for those patients who are fluid-overloaded and cannot tolerate substantial volumes of salt solution for therapy of shock or hypotension.3
3. In cardiopulmonary bypass procedures; however, the optimum regimen of fluids has not been established.

Conditions in which Albutein® 25% MAY BE indicated:

• Adult respiratory distress syndrome (ARDS).3,4
• Major injury or surgery resulting in increased albumin loss or inadequate synthesis.3,5
• Acute nephrosis not responding to cyclophosphamide or steroid therapy. Steroid therapy may increase edema which may respond to combined therapy of albumin with a diuretic.3
• Acute liver failure or ascites where the therapeutic use is regulated by the individual circumstances.3

Unless the pathologic condition responsible for hypoalbuminemia can be corrected, administration of albumin can afford only symptomatic relief. There is NO valid reason for the use of albumin as an intravenous nutrient.

Albutein® 25% is contraindicated in patients with severe anemia or cardiac failure in the presence of normal or increased intravascular volume.

The use of Albutein® 25% is contraindicated in patients with a history of allergic reactions to albumin.

The most common adverse reactions include fever and chills, rash, nausea, vomiting, tachycardia and hypotension. Should an adverse reaction occur, slow or stop the infusion for a short period of time which may result in the disappearance of the symptoms. If administration has been stopped and the patient requires additional Albutein® 25%, material from a different lot should be used. Albutein® 25%, particularly if administered rapidly, may result in vascular overload with resultant pulmonary edema.

To report SUSPECTED ADVERSE REACTIONS, contact Grifols Biologicals Inc. at 1-888-GRIFOLS (1-888-474-3657) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with Albutein® 25%. It is also not known whether Albutein® 25% can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Albutein® 25% should be given to a pregnant woman only if clearly needed.

Pediatric Use

Albutein® 25% is indicated in conjunction with exchange transfusion in the treatment of neonatal hyperbilirubinemia. The pediatric use of Albutein® 25% has not been clinically evaluated. The dosage will vary with the clinical state and body weight of the individual. Typically, a dose one-quarter to one-half the adult dose may be administered, or dosage may be calculated on the basis of 0.6 to 1.0 gram per kilogram of body weight (2.4 to 4 mL of Albutein® 25%). For jaundiced infants suffering from hemolytic disease of the newborn, the appropriate dose for binding of free serum bilirubin is 1 gram per kilogram of body weight which may be administered during the procedure.8 The usual rate of administration in children should be one-quarter the adult rate. Therefore, physicians should weigh the risks and benefits of the use of Albutein® 25% in the pediatric population.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Mechanism of Action

There are no known cases of viral hepatitis which have resulted from the administration of Albutein® 25%. Albumin is a highly soluble, globular protein (MW 66,500), accounting for 70-80% of the colloid osmotic pressure of plasma. Therefore, it is important in regulating the osmotic pressure of plasma.1,3 Albutein® 25% supplies the oncotic equivalent of approximately 5 times its volume of human plasma. It will increase the circulating plasma volume by an amount approximately 3.5 times the volume infused within 15 minutes, if the recipient is adequately hydrated.9 This extra fluid reduces hemoconcentration and decreases blood viscosity. The degree and duration of volume expansion depend upon the initial blood volume. When treating patients with diminished blood volume, the effect of infused albumin may persist for many hours. The hemodilution lasts for a shorter time when albumin is administered to individuals with normal blood volume.

Albumin is also a transport protein and binds naturally occurring, therapeutic, and toxic materials in the circulation.1

Albumin is distributed throughout the extracellular water and more than 60% of the body albumin pool is located in the extravascular fluid compartment. The total body albumin in a 70 kg man is approximately 320 g. Albumin has a circulating life span of 15-20 days, with a turnover of approximately 15 g per day.3

Albutein® 25% is supplied as a sterile, aqueous solution for single dose intravenous administration containing 25% human albumin (weight/volume). It is available in the following vial sizes:

• 50 mL vial Albutein® 25% (NDC 68516-5216-1).
• 100 mL vial Albutein® 25% (NDC 68516-5216-2).

Storage

Albutein® 25% is stable for three years provided that storage temperature does not exceed 30 °C. Protect from freezing.