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Alburx (Albumin Human) - Summary



AlbuRx 25, Albumin (Human) 25% 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 60C 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 60C 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 g/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.

3.1 General Principles17

3.1.1 Volume Deficit

Since the oncotic pressure of AlbuRx 25, Albumin (Human) 25% solution is about four times higher than that of normal human serum, it will expand the plasma volume if interstitial water is available for an inflow through the capillary walls. However, many patients suffering from an acute volume deficit also have some degree of interstitial dehydration. In the absence of hyperhydration, the treatment of an acute volume deficit with AlbuRx 25 should therefore include isotonic electrolyte solutions with an albumin:electrolyte ratio of 1:3 or 1:4. By contrast, chronic volume deficits have usually been at least partially compensated for by the renal retention of sodium and water with some degree of tissue edema, and in these circumstances a trial with AlbuRx 25 only is indicated. In any case, an anemia of clinically relevant magnitude requires specific treatment, and the metabolic needs of the patient with respect to fluid and electrolytes must be cared for.

3.1.2 Oncotic Deficit

The common causes of hypoproteinemia are protein-calorie malnutrition, defective absorption in gastro-intestinal disorders, faulty albumin synthesis in chronic hepatic failure, increased protein catabolism postoperatively or with sepsis, and abnormal renal losses of albumin with chronic kidney disease. In all these settings, the circulating albumin mass is initially maintained by a gradual transfer of extravascular albumin to the circulation, and hypoproteinemia ensues only when this compensatory potential has been exhausted. This implies that manifest hypoproteinemia is usually accompanied by a hidden extravascular albumin deficit of equal magnitude as the measurable intravascular deficit, which must be allowed for if AlbuRx 25, Albumin (Human) 25% solution is infused because of the capillary permeability of that protein.

The primary sequel of the oncotic deficit resulting from hypoproteinemia is a loss of plasma and a gain of interstitial volume with increased lymphatic flow. As a secondary response, the kidney retains sodium and water which distribute themselves on both sides of the capillary walls and the plasma volume may be returned almost to normal when the interstitial hydrostatic pressure increases sufficiently to compensate for the decrease of the serum oncotic pressure. This chain of events is accelerated by the infusion of crystalloid fluids. The plasma volume is maintained at the price of interstitial edema.2

There is some evidence that a serum oncotic pressure near 20 mmHg equaling a total serum protein (TSP) concentration of 5.2 g/100 mL represents a threshold, below which the risk of complications increases.17 The target organs of hypoproteinemia include the skin, the lungs, and the intestine.10 Cutaneous edema lowers the oxygen tension of wounds and may thus impair the healing process.5 An oncotic deficit favors the development of interstitial pulmonary edema4 and the intestinal accumulation of fluids, which may progress to a paralytic ileus.9

Relief of the basic pathology is the definitive mode of therapy for the restoration of the plasma protein content, but this process takes time to become effective, and the rapid correction of a critical oncotic deficit by the administration of AlbuRx 25, Albumin (Human) 25% solution possibly in conjunction with a diuretic may therefore be indicated, particularly in high-risk patients who have undergone abdominal, cardio-vascular, thoracic, or urologic surgery or who have acute bacteremia. In notably catabolic patients, attempts to raise the TSP level above 6 g/100 mL usually prove futile, even with massive doses of Albumin (Human).17

It is emphasized that whereas AlbuRx 25, Albumin (Human) 25% solution may be necessary to prevent or treat the aforementioned acute complications of hypoproteinemia, it is not indicated for treatment of the chronic condition itself.

3.2 Specific Indications17

3.2.1 Acute circumstances in which AlbuRx 25, Albumin (Human) 25% solution use is usually appropriate


Though electrolyte solutions such as Ringer's lactate and colloid-containing plasma substitutes may be used as an emergency treatment of shock, AlbuRx 25, Albumin (Human) 25% solution used according to the aforementioned principles has a much longer intravascular half-life and may therefore be preferable. In addition, anemia of clinically relevant magnitude requires specific therapy with red cells.


Immediate therapy during the first 24 hours is directed at the administration of large volumes of crystalloid solutions and lesser amounts of AlbuRx 25, Albumin (Human) 25% solution to maintain an adequate plasma volume and protein (colloid) content. For continuation of therapy beyond 24 hours, larger amounts of AlbuRx 25 and lesser amounts of crystalloid are generally used.17 An optimum regimen for the use of Albumin (Human), electrolytes, and fluid in the early treatment of burns has, however, not yet been established.

With restoration of normal capillary function, a close relationship exists once again between infused Albumin (Human) and resultant increase in plasma oncotic pressure. A goal should be sought of maintaining a plasma albumin concentration of about 2.5 0.5 g/100 mL or a plasma oncotic pressure of 20 mmHg (equivalent to a TSP concentration of 5.2 g/100 mL).17 In the presence of extensive granulating wounds, a daily loss of up to 30 g of albumin may continue into the late post-burn period.1 Protein-rich oral feedings, or adequate parenteral nutrition should be included in the overall regimen to the fullest possible extent, though such treatment does not permit the rapid correction of an oncotic deficit.

3.2.2 Acute circumstances in which AlbuRx 25, Albumin (Human) 25% solution use may be appropriate

Adult Respiratory Distress Syndrome

Several factors are usually involved in the development of the state now commonly called the adult respiratory distress syndrome, one of these being a hypoproteinemic fluid overload. If present, this may be corrected by the use of AlbuRx 25, Albumin (Human) 25% solution and a diuretic.14,17

Cardiopulmonary Bypass

An adequate blood volume during cardiopulmonary bypass can be maintained with crystalloids as the only pump priming fluid, but only at the price of interstitial edema. A commonly employed program is an AlbuRx 25, Albumin (Human) 25% solution and crystalloid pump prime adjusted so as to achieve a hematocrit of 20% and a plasma albumin level of 2.5 g/100 mL in the patient, but the level to which either may be lowered safely has not yet been defined.17

Pre- and postoperative Hypoproteinemia

Patients undergoing major surgery may lose more than half of their circulating albumin mass6,9,15, and complications attributable to an oncotic deficit may occur in such cases, as well as in septic and intensive care patients. Oncotic therapy with AlbuRx 25, Albumin (Human) 25% solution may therefore be indicated in such patients, according to the principles outlined in 3.1.2. Temporary redistribution of protein is usually not an indication for Albumin (Human).

Third Space Problems of Infectious Origin

The sequestration of protein-rich fluid during acute peritonitis, pancreatitis, mediastinitis or extensive cellulitis may be of sufficient magnitude to require the treatment of a volume or an oncotic deficit with AlbuRx 25, Albumin (Human) 25% solution3, although this occurrence is relatively rare.

Acute Liver Failure

In acute liver failure, AlbuRx 25, Albumin (Human) 25% solution may serve the triple purpose of stabilizing the circulation, correcting an oncotic deficit and binding excessive serum bilirubin. The therapeutic approach is guided by the individual circumstances.17

Acute Nephrosis

Patients with acute nephrosis may prove refractory to cyclophosphamide or steroid therapy and their edema may even be aggravated initially by steroids. In such cases, a response may be elicited by combining 100 mL of 2025% Albumin (Human) solution with an appropriate diuretic. This combination should be repeated daily for about one week, after which the patient may react satisfactorily to drug therapy.17


The use of AlbuRx 25, Albumin (Human) 25% solution for blood volume support may be indicated if circulatory instability follows the withdrawal of ascitic fluid.

Red Cell Resuspension Media

As a rule, the use of Albumin (Human) for resuspending red cells can be dispensed with. However, in exceptional circumstances such as certain types of exchange transfusions and the use of very large volumes of erythrocyte concentrates and frozen or washed red cells, the addition of AlbuRx 25, Albumin (Human) 25% solution to the resuspension medium may be indicated in order to provide sufficient volume and/or avoid excessive hypoproteinemia during the subsequent transfusion. If necessary, 2025 g or more of Albumin (Human) per liter of red cell suspension should be added as a concentrated solution to the isotonic, electrolyte suspension of erythrocytes immediately before transfusion, the individual dosage depending on the TSP level of the recipient.

Renal Dialysis

Patients undergoing long-term hemodialysis may need AlbuRx 25, Albumin (Human) 25% solution for the treatment of a volume or an oncotic deficit. As a rule, the initial dose should not exceed 100 mL of a 2025% solution, and the patients should be carefully observed for signs of a circulatory overload, to which they are particularly sensitive.

Hemolytic Disease of the Newborn

AlbuRx 25, Albumin (Human) 25% solution may be indicated in order to bind and thus detoxify free serum bilirubin in severely hemolytic infants pending an exchange transfusion.

3.2.3 Circumstances in which AlbuRx 25, Albumin (Human) 25% solution use is not justified

For the reasons set forth in sections 2. and 3.1, there is no valid reason for the use of AlbuRx 25, Albumin (Human) 25% solution as an intravenous nutrient or for treating the stabilized hypoproteinemia accompanying chronic cirrhosis, chronic nephrosis, protein-losing enteropathy, malabsorption and pancreatic insufficiency.

If, however, a patient in this category has to cope with a superimposed acute stress, e.g. anesthesia, surgery or major infections, the patient's hemodynamic state, oncotic deficit and fluid balance should be carefully assessed and the appropriate steps taken as indicated by the individual circumstances.

See all Alburx indications & dosage >>


Media Articles Related to Alburx (Albumin Human)

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Published Studies Related to Alburx (Albumin Human)

Glycated albumin predicts the effect of dual and single antiplatelet therapy on recurrent stroke. [2015]
recurrence of stroke in patients on either dual or single antiplatelet therapy... CONCLUSIONS: GA could be a potential biomarker to predict the effects of dual and

Effects of combined lipoic acid and pyridoxine on albuminuria, advanced glycation end-products, and blood pressure in diabetic nephropathy. [2013]
This study was designed to investigate the effects of combined administration of lipoic acid and pyridoxine on albuminuria, oxidative stress, blood pressure, serum advanced glycation end-products, nitric oxide (NO), and endothelin-1 in patients with diabetic nephropathy.

High-dose albumin treatment for acute ischaemic stroke (ALIAS) Part 2: a randomised, double-blind, phase 3, placebo-controlled trial. [2013]
proportion of patients with a favourable outcome... INTERPRETATION: Our findings show no clinical benefit of 25% albumin in patients

Albumin resuscitation for traumatic brain injury: is intracranial hypertension the cause of increased mortality? [2013]
Mortality is higher in patients with traumatic brain injury (TBI) resuscitated with albumin compared with saline, but the mechanism for increased mortality is unknown...

Associations of albuminuria in patients with chronic heart failure: findings in the ALiskiren Observation of heart Failure Treatment study. [2011.07]
CONCLUSIONS: Increased UACR is common in patients with heart failure, including non-diabetics. Urinary albumin creatinine ratio is independently associated with HbA1c and NT-proBNP, even in non-diabetic patients.

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Clinical Trials Related to Alburx (Albumin Human)

Treatment of Subarachnoid Hemorrhage With Human Albumin [Terminated]
The purpose of this study is to evaluate the tolerability and safety of 25 percent human albumin therapy in patients with subarachnoid hemorrhage.

Efficacy and Safety of Plasma Exchange With 5% Albutein in Beta-Amyloid Peptide Clearance in Cerebrospinal Fluid [Completed]
The purpose of this study is to evaluate the efficacy and safety of plasma exchange with 5% albumin in beta-amyloid peptide clearance in cerebrospinal fluid, and its effects in patients with mild-moderate Alzheimer's disease.

Study to Evaluate the Safety of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients [Not yet recruiting]
This is a randomized, controlled, open-label clinical trial to be conducted at approximately 12 surgical and pediatric intensive care units (SICU/NICU/PICU) in the US, over a period of 22 months, with 6 months for trial set-up, 12 months of simultaneous subject enrollment and 30 days of treatment/follow-up period, and 3 months for study close-out. The study population will consist of at least 60 male and female pediatric subjects between 0 days and 12 years of age, undergoing cardiac, abdominal, orthopedic or transplant surgery with an approximately equal number of subjects (n=10 to 25) in three of the four age groups: (29 days to 23 months), (2 to 5 years 11 months) and (6 years to 12 years) cohorts. Regarding the youngest age group of 0 to 28 days, the minimum number of patients to be enrolled in the study will not be predefined as very a small number of elective surgical procedures is expected in this population. Safety concerns and eventual safety signals, as well as recruitment rate, will be monitored annually (starting from the enrollment of the 60th subject) by an independent Safety Monitoring Board (SMB), which will be appointed prior to study initiation and submitted to the FDA. The responsibilities of the SMB will be defined in ad hoc document, in which the threshold for acceptable safety will also be set. During the conduct of the study on the first 60 patients, if there is any safety signal linked to the primary safety endpoint (i. e. pulmonary fluid overload) or imbalance in the incidence of AEs between the treatment and control groups or based on relevant literature, as judged by the SMB, the enrolment will be increased to 100 patients using the same age stratification approach defined above (n=20 to 30 in each age group). Potential subjects will be pre-screened and informed consent/assent will be obtained from the subject and/or subject's parents or guardians prior to surgery. Post-surgery, the subject will be admitted to the Surgical, Neonatal, or Pediatric Intensive Care Unit (SICU/NICU/PICU) for postoperative recovery and care management. Subjects who show signs of hypovolemia as judged by the Principal Investigator (PI) will be screened to determine their eligibility to participate in this trial. Subjects will then be randomized to receive treatment with Kedbumin 25% or the comparator, normal saline (sodium chloride 0. 9%). There is no specific post-treatment regimen for this protocol, as all subjects will receive the standard post-operative care based on their clinical status and response to treatment at the discretion of the Investigator. Vital signs and fluid management/replacement therapy recorded in the medical chart and results of standard complete blood count (CBC), biochemistry, and hematology and coagulation lab panels will be reviewed and recorded by research staff at specified time points, according to the hospital standard of care. Additionally, research staff will review and record daily lactate, urine albumin, blood urea nitrogen (BUN), creatinine, and non-invasive measurements at the following time points: Baseline, 6hr, 12hr, 24hr, 36hr, 48hr, and 72hr post-onset of hypovolemia), until hemodynamic stability is achieved. Hemodynamic stability will be evaluated based on site-specific age-defined reference ranges for heart rate, blood pressure, urine output, and cardiac index in children. The volume, rate and frequency of the Investigational Medicinal Product (IMP, either Kedbumin 25% or normal saline) administered will be recorded in addition to the type, timing, and amount of all other fluids administered. The time to hemodynamic stability, duration of stability once attained, and any relapse requiring additional treatment or use of secondary resuscitation strategies will be recorded. Subjects who demonstrate hemodynamic stability within 3 days after treatment initiation and then relapse into hemodynamic instability as a result of surgical complications or infection will exit from the study, but the data be considered for the safety analysis. These subjects should continue treatment according the clinical practice standard since the study is not intended to evaluate the efficacy of Kedbumin 25%.

Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase I Study in Chinese Healthy Volunteers [Completed]
This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein single dose in Chinese healthy volunteers.

Treatment of Subarachnoid Hemorrhage With Human Albumin [Terminated]
The proposed study was set up to evaluate the tolerability and safety of 25% human albumin (HA) therapy in patients with subarachnoid hemorrhage (SAH). It is estimated that 37,500 people in the USA have SAH every year. SAH is associated with a 51% mortality rate and one third of survivors are left functionally dependent. Cerebral vasospasm (CV) has been identified as the most important reason for neurological deterioration. CV may be due to multiple molecular mechanisms. The use of a neuroprotective agent with various actions, likes HA, would be important for prevention of CV and improved clinical outcome in patients with SAH. The proposed open-label, dose-escalation study will have important public health implications by providing necessary information for a definitive phase III clinical trial regarding the efficacy of treatment with HA in patients with SAH. The study was to enroll a maximum of 80 patients with SAH who meet the eligibility criteria. Four dosages of HA (0. 625, 1. 25, 1. 875, and 2. 5 g/kg) administered daily for seven days will be evaluated. The lowest dosage was to be evaluated in the first group of 20 subjects. A specific safety threshold was defined based on data from previous studies. The Data and Safety Monitoring Board approved or disapproved advancing to the next higher HA dosage based on the evaluation of the rate of congestive heart failure (CHF). The study assessed three outcomes: safety and tolerability of the HA dosages and the functional outcome. The primary tolerability outcome was defined as the subject's ability to receive the full allocated dose of HA without incurring frank CHF that requires termination of treatment. Secondary safety outcomes were serious adverse events (including neurological and medical complications, and anaphylactic reactions). Neurological complications comprise incidence of CV, rebleeding, hydrocephalus, and seizures after treatment. The three-month functional outcome determined, by Glasgow Outcome Scale, Barthel Index, modified Rankin Scale, NIH Stroke Scale and Stroke Impact Scale was measured to obtain a preliminary estimate of the treatment effect of HA. The timeline of the study is three years.

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Page last updated: 2017-02-24

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