Albuminex

ALBUMINEX 5% is a 5% albumin solution indicated for adults and children:

• Hypovolemia (
  1.1 Hypovolemia

  ALBUMINEX 5% is indicated for restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate e.g. hypovolemia following shock due to trauma or sepsis, in surgical patients and in other similar conditions with volume deficiency when restoration and maintenance of circulating blood volume is required in both adult and pediatric patients. In pediatric patients to reverse hypovolemia and achieve normal capillary refill time.^{1, 2, 3, 4, 5, 6, 7, 8}
  )
• Ascites (
  1.2 Ascites

  ALBUMINEX 5% is indicated for prevention of central volume depletion and maintenance of cardiovascular function after large volume parencentesis in patients with liver cirrhosis or other chronic liver disease in adults and children.^{9, 10, 11, 12}

  ALBUMINEX 5% infusion plus administration of vasoactive drugs is indicated in the treatment of type I hepatorenal syndrome.⁶

  For patients with spontaneous bacterial peritonitis ALBUMINEX 5% is indicated as adjuvant treatment to antibiotic therapy.^{9, 10, 13}
  )
• Hypoalbuminemia including from burns (
  1.3 Hypoalbuminemia including from burns

  ALBUMINEX 5% is indicated in patients with severe burn injury (> 20% total body surface area), but not until at least 12 to 24 hours after the burn, in order to correct protein loss, decrease overall fluid requirements, decrease systemic edema and stabilize cardiovascular hemodynamics without fluid overload (initial resuscitation should be with crystalloids).^{8, 14}ALBUMINEX 5% is also indicated in patients with pre- or post-operative hypoproteinemia and for third space protein loss due to infection or burns.
  )
• Acute Nephrosis (
  1.4 Acute Nephrosis

  ALBUMINEX 5% is indicated in patients with acute nephrosis in combination with loop diuretics to reinforce the diuretic therapeutic effect, which is reduced by hypoalbuminemia, and for the correction of reduced oncotic pressure.^{15, 16}
  )
• Acute Respiratory Distress Syndrome (ARDS) (
  1.5 Acute Respiratory Distress Syndrome (ARDS)

  ALBUMINEX 5% is indicated in conjunction with diuretics to correct fluid volume overload associated with ARDS.^{17, 18, 19}
  )
• Cardiopulmonary Bypass (
  1.6 Cardiopulmonary Bypass

  ALBUMINEX 5% is indicated in cardiopulmonary bypass procedures as part of the priming fluids to passivate the synthetic surfaces of the extracorporeal circuit and maintain the patient's colloid oncotic pressure.^{20, 21, 22, 23, 24, 25}
  )

For intravenous administration only.

ALBUMINEX 5% is a sterile, aqueous solution of human albumin (5% w/v i.e. 5 g/dL) for intravenous administration available as:

• 250 mL (12.5 g) single dose vial
• 500 mL (25 g) single dose vial

There are no data with ALBUMINEX 5% use in pregnant women to inform on drug-associated risk. Animal reproduction studies have not been conducted using ALBUMINEX 5%. It is not known whether ALBUMINEX 5% can cause fetal harm when administered to a pregnant woman or can affect fertility. ALBUMINEX 5% should be given to a pregnant woman only if clearly needed. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

• Suspicion of allergic or anaphylactic reactions requires immediate discontinuation of the injection and implementation of appropriate medical treatment (
  5.1 Hypersensitivity Reactions

  Suspicion of allergic or anaphylactic reactions, require immediate discontinuation of the infusion and implementation of appropriate medical treatment.
  )
• Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the patient's volume status. Use with caution in conditions where hypervolemia and its consequences or hemodilution could represent a special risk to the patient. (
  5.2 Hypervolemia

  Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the patient's volume status. At the first clinical signs of cardiovascular overload (headache, dyspnea, jugular venous distention, increased blood pressure), the infusion must be slowed or stopped immediately.

  Use albumin with caution in conditions where hypervolemia and its consequences or hemodilution could represent a special risk to the patient. Examples of such conditions are:

  • Decompensated heart failure
  • Hypertension
  • Esophageal varices
  • Pulmonary edema
  • Hemorrhagic diathesis
  • Severe anemia
  • Renal and post-renal anuria
  )
• Assess electrolytes, coagulation and hematology parameters, and hemodynamic status when albumin is administered (
  5.4 Clinical Hemodynamic Parameters

  The colloid osmotic pressure of ALBUMINEX 5% is about the same as plasma.

  The following parameters should be assessed during administration of ALBUMINEX 5%:

  • Arterial blood pressure and pulse rate
  • Central venous pressure
  • Pulmonary artery occlusion pressure
  • Urine output
  • Electrolytes
  • Hematocrit/hemoglobin
  )
• Do not dilute with sterile water for injection (
  2.3 Administration

  • Visually inspect the solution for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • Do not use if there are any particulates seen or if the solution is discolored.
  • If a large volume is infused, ensure that the vial is at room temperature before infusion.
  • Do not dilute with Sterile Water for Injection as hemolysis may occur. ALBUMINEX 5% may be diluted with 0.9% saline or 5% dextrose.
  • Begin the infusion within 4 hours of piercing the vial stopper (the product does not contain any preservative).
  • Adjust the rate of infusion according to the individual patient's hemodynamic and other physiological responses, using appropriate clinical monitoring.
  ,
  5.5 Pre-infusion preparation

  ALBUMINEX 5% must not be diluted with sterile water for injection as this may cause hemolysis in recipients. The product can be diluted in an isotonic solution (e.g., 5% dextrose in water or 0.9% sodium chloride) [see

  Dosage and Administration (2.2)

  ].
  ,
  7 DRUG INTERACTIONS

  Do not mix ALBUMINEX 5% with blood, blood components, protein hydrolysates, alcoholic solutions or other medicinal products. Although it is not usually necessary to dilute Albuminex 5%, if it should be necessary, it may be diluted with 0.9% saline or 5% dextrose. However, it can be administered, via a separate IV line, concomitantly with other parenterals.
  )
• This product is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent. (
  5.5 Pre-infusion preparation

  ALBUMINEX 5% must not be diluted with sterile water for injection as this may cause hemolysis in recipients. The product can be diluted in an isotonic solution (e.g., 5% dextrose in water or 0.9% sodium chloride) [see

  Dosage and Administration (2.2)

  ].
  )