Albutein

Patient Information

This product is usually given in a hospital setting.

Inform patients being treated with ALBUTEIN 20% about the risks and benefits of its use [see ADVERSE REACTIONS].

Inform patients to immediately report the following signs and symptoms to their physician:

• Allergic or anaphylactic type reactions [see WARNINGS AND PRECAUTIONS].
• Cardiovascular overload (e.g., headache, dyspnea and jugular venous distention) [see WARNINGS AND PRECAUTIONS].
• Increased blood pressure, raised venous pressure and pulmonary edema [see WARNINGS AND PRECAUTIONS].

Inform patients that ALBUTEIN 20% is a derivative of human plasma and may contain infectious agents that cause disease (e.g., viruses, and theoretically, the CJD agent). Inform patients that the risk that ALBUTEIN 20% may transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing the donated plasma for certain viral agents and by the inactivation and/or removal of certain viruses during the manufacturing process [see WARNINGS AND PRECAUTIONS].

Description

ALBUTEIN 20% is a sterile, aqueous solution for single dose intravenous administration containing 20% human albumin (weight/volume). ALBUTEIN 20% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. The colloid osmotic effect of human albumin 20% is approximately four times that of normal human plasma. A liter of ALBUTEIN 20% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives.

ALBUTEIN 20% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 20% is heated at 60 °C for ten hours against the possibility of transmitting viruses.

Hypovolemia

For restoration and maintenance of circulating blood volume where hypovolemia is demonstrated and colloid use is appropriate. When hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20-25% albumin solutions should be used.^1,2,3

Acute liver failure is a special situation in which both hypovolemia and hypoalbuminemia can be present. ALBUTEIN 20% can be used in such cases.¹

ALBUTEIN 20% may be of value in the treatment of shock or hypotension in renal dialysis patients.¹

Cardiopulmonary Bypass Procedures (Treatment Adjunct)

Preoperative dilution of blood using albumin and crystalloid can be used in cardiopulmonary bypass procedures. Albumin also may be used in the priming fluid.^4,5,6

Acute Nephrosis (Treatment Adjunct)

ALBUTEIN 20% may be used to treat peripheral edema in patients with acute nephrosis who are refractory to cyclophosphamide, corticosteroid therapy or diuretics.^1,2,7

Hypoalbuminemia

ALBUTEIN 20% may be indicated for subjects with hypoalbuminemia who are critically ill and/or actively bleeding. When albumin deficit is the result of excessive protein loss, the effect of ALBUTEIN 20% administration will be temporary unless the underlying disorder is reversed.^8,9,10 Septic patients and patients undergoing major surgery may lose more than half of their circulating plasma volume. ^1,11 Treatment with ALBUTEIN 20% may be of value in such cases, especially when plasma colloid oncotic pressure is abnormally low.¹

In the first 24 hours after thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. Beyond 24 hours, ALBUTEIN 20% can be used to maintain plasma colloid osmotic pressure.^2,12,13 Protein loss from the third space due to infection (acute peritonitis, pancreatitis, mediastinitis or extensive cellulitis) may require treatment with an infusion of albumin.^14,15

Ovarian Hyperstimulation Syndrome

ALBUTEIN 20% may be used as a plasma volume expander in fluid management relating to severe forms of ovarian hyperstimulation syndrome.^16,17

Neonatal Hyperbilirubinemia

ALBUTEIN 20% is indicated for the treatment of neonatal hyperbilirubinemia. It may be used prior to or during an exchange procedure in an attempt to bind free bilirubin and enhance its excretion.^18,19,20

Adult Respiratory Distress Syndrome (ARDS) (Treatment Adjunct)

ALBUTEIN 20% infusions may be indicated in conjunction with diuretics to correct fluid overload and hypoproteinemia associated with ARDS.^6,21

Prevention Of Central Volume Depletion After Paracentesis Due To Cirrhotic Ascites (Treatment Adjunct)

ALBUTEIN 20% may be used to maintain cardiovascular function following removal of large volumes of ascitic fluid after paracentesis due to cirrhotic ascites.^2,22,23,24

Dosage And Administration

For Intravenous Use Only

Dosage

Adjust the concentration, dosage and infusion rate of the albumin preparation to the patient’s individual requirements.

The dose required depends on the patient’s body weight, severity of injury/illness and on continuing fluid and protein losses. Use adequacy of circulating blood volume, not plasma albumin levels, to determine the dose required.

Administration

Intravenous use only

• ALBUTEIN 20% is a clear and slightly viscous solution. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is turbid or if there is sediment in the bottle.
• Do not freeze.
• Warm product to room temperature before use if large volumes are administered.
• ALBUTEIN 20% contains no preservatives. Do not begin administration more than 4 hours after the container has been entered. Discard unused portion.
• Do not dilute with sterile water for injection. The product can be diluted in an isotonic solution (e.g., 5% dextrose in water or 0.9% sodium chloride) [see WARNINGS AND PRECAUTIONS].
• Adjust the infusion rate to the individual circumstances and the indication.

How Supplied

Dosage Forms And Strengths

ALBUTEIN 20% is a solution containing 200 g per L of total protein of which at least 95% is human albumin.

Storage And Handling

ALBUTEIN 20% is supplied in single-use, individually laser etched vials.

The following vial sizes of ALBUTEIN 20% are available:

Each vial-size label incorporates integrated hangers. Each label has a peel-off strip showing the product name and lot number.

ALBUTEIN 20% is stable for three years provided the storage temperature does not exceed 30 °C. Protect from freezing.

REFERENCES

1. Tullis JL. Albumin: 1. Background and Use. 2. Guidelines for Clinical Use. JAMA. 1977;237:355-360, 460-463.

2. Vermeulen LC, et al. A Paradigm for Consensus. Arch Intern Med. 1995;155:373-379.

3. SAFE Study investigators. A comparison of albumin and saline for fluid resuscitation in the intensive care unit. N Engl J Med. 2004;350:2247-2256.

4. Sedrakyan A, Gondek K, Paltiel D, et al. Volume expansion with albumin decreases mortality after coronary artery bypass graft surgery. Chest. 2003;123:1853-1857.

5. Russell JA, Navickis RJ, Wilkes MM. Albumin versus crystalloid for pump priming in cardiac surgery: meta-analysis of controlled trials. J Cardiothorac Vasc Anesth. 2004;18:429-37.

6. American Thoracic Society. Evidence-based colloid use in the critically ill: American Thoracic Society consensus statement. Am J Respir Crit Care Med. 2004;170:1247-59.

7. Fliser D, Zurbruggen I, Mutschler E, et al. Coadministration of albumin and furosemide in patients with nephrotic syndrome. Kidney Int. 1999;55:629-34.

8. Mendez CM, McClain CJ, Marsano LS. Albumin Therapy in Clinical Practice. Nutrition in Clinical Practice. 2005;20:314-320.

9. Haynes GR, Navickis RJ, Wilkes MM. Albumin administration-what is the evidence of clinical benefit? A systematic review of randomized controlled trials. Eur J Anaesthesiol. 2003 Oct;20(10):771-93.

10. Vincent JL, Navickis RJ, Wilkes MM. Morbidity in hospitalized patients receiving human albumin: a meta-analysis of randomized, controlled trials. Crit Care Med. 2004;32:2029-38.

11. Skillman JJ, Tanenbaum BJ. Current Topics in Surgical Research. Vol. 2. New York: Academic Press. 1970;523.

12. Muir IA, Barclay TL. Burns and their treatment. Chicago: Year Book Medical Publishers. 1974.

13. Pruitt BA Jr, Goodwin CW Jr. Current treatment of the extensively burned patient. Surg Annu. 1983;15:331-64.

14. Clowes GHA Jr, Vucinic M, Weidner MG. Circulatory and metabolic alterations associated with survival or death in peritonitis: clinical analysis of 25 cases. Ann Surg. 1966;166:866-85.

15. Sort P, Navasa M, Arroyo V, et al. Effect of intravenous albumin on renal impairment and mortality in patients with cirrhosis and spontaneous bacterial peritonitis. N Engl J Med. 1999;341:403-409.

16. Aboulghar M, Evers JH, Al Inany H. Intravenous albumin for preventing severe ovarian hyperstimulation syndrome: a Cochrane review. Hum Reprod. 2002;17:3027-3032.

17. Practice Committee of the American Society for Reproductive Medicine. Ovarian hyperstimulation syndrome. Fertil Steril. 2006;86:S178-S183.

18. Tsao YC, Yu VY. Albumin in management of neonatal hyperbilirubinaemia. Arch Dis Child. 1972;47:250-256.

19. Practice parameter: management of hyperbilirubinemia in the healthy term newborn. Pediatrics. 1994;94(4 pt 1):558-62.

20. Dennery PA, Seidman DS, Stevenson DK. Neonatal hyperbilirubinemia. N Eng J Med. 2001;344:581-90.

21. Martin GS, et al. A randomized, controlled trail of furosemide with or without albumin in hypoproteinemic patients with acute lung injury. Crit Care Med. 2005; 33:1681-1687.

22. Gines P, Cardenas A, Arroyo V, et al. Management of cirrhosis and ascites. N Engl J Med. 2004;350:1646-54.

23. Runyon BA. AASLD Practice Guidelines. Management of adult patients with ascites due to cirrhosis. Hepatology. 2009;49(6):2087-107.

24. Moore KP, Wong F, Gines P, et al. The management of ascites in cirrhosis: report on the consensus conference of the International Ascites Club. Hepatology. 2003;38:258-66.

Manufactured by: Grifols Biologicals LLC, 5555 Valley Boulevard, Los Angeles, CA 90032, U.S.A., U. S. License No. 1694. Revised: Jun 2018

The most serious adverse reactions are anaphylactic shock, heart failure and pulmonary edema.

The most common adverse reactions are anaphylactoid type reactions.

Adverse reactions to ALBUTEIN 20% normally resolve when the infusion rate is slowed or the infusion is stopped. In case of severe reactions, the infusion is stopped and appropriate treatment initiated.

Clinical Trials Experience

No clinical studies were done using ALBUTEIN 20%.

Post-marketing Experience

Because adverse reactions are reported voluntarily post-approval from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to product exposure. The following adverse reactions have been identified during post approval use of human albumin, including ALBUTEIN (all strengths) in decreasing order of significance:

• Anaphylactic shock
• Heart failure
• Pulmonary edema
• Hypotension
• Tachycardia
• Vomiting
• Urticaria
• Rash
• Headache
• Chills
• Fever
• Flushing
• Nausea

Drug Interactions

ALBUTEIN 20% must not be mixed with other medicinal products.

Included as part of the PRECAUTIONS section.

Precautions

Hypersensitivity

Suspicion of allergic or anaphylactic reactions requires immediate discontinuation of the infusion and implementation of appropriate medical treatment.

Hypervolemia/Hemodilution

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

Dehydration

The colloid-osmotic effect of human albumin 20% is approximately four times that of blood plasma. Therefore, when concentrated albumin is administered, care must be taken to assure adequate hydration of the patient. Patients should be monitored carefully to guard against circulatory overload and hyperhydration. Patients with marked dehydration require administration of additional fluids.

Electrolyte Imbalance

20% – 25% human albumin solutions are relatively low in electrolytes compared to 4% – 5% human albumin solutions. Monitor regularly the electrolyte status of the patient and take appropriate steps to restore or maintain the electrolyte balance when albumin is administered.

Coagulation Abnormalities

Regular monitoring of coagulation and hematology parameters is necessary if comparatively large volumes are to be replaced. Care must be taken to ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets and erythrocytes).

Laboratory Monitoring

Monitor regularly hemodynamic parameters during administration of ALBUTEIN 20%; this may include:

• Arterial blood pressure and pulse rate
• Central venous pressure
• Pulmonary artery occlusion pressure
• Urine output
• Electrolytes
• Hematocrit/hemoglobin

Application Precautions

ALBUTEIN 20% 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].

Transmissible Infectious Agents

Albumin is a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is also considered extremely remote. No cases of transmission of viral diseases or CJD have been identified for ALBUTEIN 20%.

Use In Specific Populations

Pregnancy

Pregnancy Category C.

Animal reproduction studies have not been conducted with ALBUTEIN 20%. It is also not known whether ALBUTEIN 20% can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Albutein 20% should be given to a pregnant woman only if clearly needed.

Labor And Delivery

No human or animal data. Use only if clearly needed.

Nursing Mothers

No human or animal data. Use only if clearly needed.

Pediatric Use

No human or animal data. Use only if clearly needed.

Geriatric Use

No human or animal data. Use only if clearly needed.

No Information provided

Contraindications

• Hypersensitivity to albumin preparations or to any of the excipients.
• Severe anemia or cardiac failure with normal or increased intravascular volume.