NDC 64208-2510 Albuminex

Albumin Human

NDC Product Information

Albuminex with NDC 64208-2510 is a a human prescription drug product labeled by Bpl. The generic name of Albuminex is albumin human. The product's dosage form is solution and is administered via intravenous form.

Labeler Name: Bpl

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Albuminex Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ALBUMIN HUMAN .05 g/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CAPRYLIC ACID (UNII: OBL58JN025)
  • SODIUM ACETYLTRYPTOPHANATE (UNII: 3EN9H0M2FX)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Human Serum Albumin - [EPC] (Established Pharmacologic Class)
  • Increased Intravascular Volume - [PE] (Physiologic Effect)
  • Increased Oncotic Pressure - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Serum Albumin - [Chemical/Ingredient]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bpl
Labeler Code: 64208
FDA Application Number: BLA125644 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: BLA - A product marketed under an approved Biologic License Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Albuminex Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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

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, 12ALBUMINEX 5% infusion plus administration of vasoactive drugs is indicated in the treatment of type I hepatorenal syndrome. 6For patients with spontaneous bacterial peritonitis, ALBUMINEX 5% is indicated as adjuvant treatment to antibiotic therapy. 9, 10, 13

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.

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

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

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

2 Dosage And Administration

For intravenous administration only.

2.1 Dosage

The concentration of ALBUMINEX 5% used, its dosage, and infusion rate should be adjusted to the patient's individual requirements and clinical indication.IndicationDoseHypovolemiaHypovolemia Adults: Initial dose of 25 g. If hemodynamic stability is not achieved within 15 to 30 minutes, an additional dose may be given. For acute liver failure: initial dose of 12 to 25 g. An infusion rate of 1-2 mL per minute is usually indicated. For renal dialysis; the initial dose should not exceed 25 g and patients should be carefully observed for signs of fluid overload.Prevention of central volume depletion after paracentesis due to cirrhotic ascitesAdults: 8 g for every 1000 mL of ascitic fluid removed.Hypoalbuminemia including from burnsAdults: 50 to 75 g For pre- and post-operative hypoproteinemia: 50 to 75 g. In burns, therapy usually starts with administration of large volumes of crystalloid solution to maintain plasma volume. After 24 hours: initial dose of 25 g and dose adjustment to maintain plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g per 100 mL. Third space protein loss due to infection or burns: initial dose of 50 to 100 g. An infusion rate of 1-2 mL per minute is usually indicated in the absence of shock. Treatment should always be guided by hemodynamic response.Acute nephrosisAdults: 25 g together with diuretic once a day for 7-10 daysAdult respiratory distress syndrome (ARDS)Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if necessary.Cardiopulmonary bypass proceduresAdults: Initial dose of 25 g. Additional amounts may be administered as clinically indicated.

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.

3 Dosage Forms And Strengths

  • 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 vial500 mL (25 g) single dose vial

4 Contraindications

  • ALBUMINEX 5% is contraindicated in patients with:Hypersensitivity to human albumin or any of the excipientsSevere anemia or cardiac failure with normal or increased intravascular volume

5.1 Hypersensitivity Reactions

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

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 failureHypertensionEsophageal varicesPulmonary edemaHemorrhagic diathesisSevere anemiaRenal and post-renal anuria

5.3 Laboratory Parameters

When large volumes of albumin are being infused, control of coagulation parameters and hematocrit value is essential. Also, ensure adequate substitution of other blood constituents such as coagulation factors, electrolytes, platelets and erythrocytes, as appropriate.

5.4 Clinical Hemodynamics 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 rateCentral venous pressurePulmonary artery occlusion pressureUrine outputElectrolytesHematocrit/hemoglobin

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)].

5.6 Infectious Diseases

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 ever been identified for ALBUMINEX 5%.

6.1 General

In general, human albumin solutions are well-tolerated and no specific, clinically relevant alterations in organ function or coagulopathy have been substantiated. 26The most common adverse reactions associated with infusion of human albumin solutions are rigors, hypotension/decreased BP, tachycardia/increased heart rate, pyrexia, feeling cold (chills), nausea, vomiting, dyspnea/bronchospasm, rash/pruritus. Reactions usually resolve when the infusion is slowed or stopped.Anaphylaxis, with or without shock, may occur and in this situation, stop the infusion.

6.2 Clinical Trials Experience

No clinical studies were done using ALBUMINEX 5%.

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.

Other

Risk SummaryThere 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.

Risk SummaryThere is no information regarding the presence of ALBUMINEX 5% in human milk, the effects on the breast-fed infant, or the effects on milk production. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for ALBUMINEX 5% and any potential adverse effects on the breast-fed infant from ALBUMINEX 5% or from the underlying maternal condition.

How ALBUMINEX 5% is suppliedALBUMINEX 5%, 5 g/dL in clear Type II glass vials.StrengthGrams and fill sizeNDC carton numberNDC vial number5%12.5 g in 250 mL64208-2510-164208-2510-25%25 g in 500 mL64208-2510-564208-2510-6Not all pack sizes may be marketed.

Manufactured by: Bio Products Laboratory Ltd., Elstree, WD6 3BX. United KingdomU.S. Distributor: Bio Products Laboratory USA Inc., 302 East Pettigrew Street, Suite C-190, Durham, NC 27701 USAU.S. Licence No:1811ALBUMINEX® is a registered trademark of Bio Products Laboratory Ltd.

8.4 Pediatric Use

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

8.5 Geriatric Use

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

11 Description

ALBUMINEX 5% is a sterile, ready-for-use, clear, slightly viscous, almost colorless, yellow, amber or slightly green aqueous solution of human albumin for single dose intravenous infusion. It is prepared from the pooled plasma of US donors in FDA-licensed facilities in the US. The product also contains 130-160 mmol/L of sodium, less than 200 micrograms/L of aluminum and is stabilized with caprylate (0.08 mmol/g albumin) and acetyltryptophanate (0.08 mmol/g albumin) but does not contain any preservative.12.5 g (250 mL) of ALBUMINEX 5% is oncotically equivalent to 250 mL plasma.25 g (500 mL) of ALBUMINEX 5% is oncotically equivalent to 500 mL plasma.The vials are closed with a synthetic rubber stopper. The stopper is not made with natural rubber latex.The viral risk from human plasma is minimized by the fractionation process and pasteurization of the albumin solution for 10 hours at 60°C (140°F) in its final container. These processes are effective for both enveloped and non-enveloped viruses. There have been no reports of virus transmission with products manufactured using this combination of processes.Typical reductions of experimental viral loads are shown in Table 1.Table 1: Virus Reduction for Albumin (Human) 5%Mean Reduction Factors (log10)Enveloped VirusEnveloped VirusEnveloped VirusEnveloped VirusNon-Enveloped VirusNon-Enveloped Virusnd: not determinedHIV-1: Human Immunodeficiency Virus Type 1BVDV: Bovine Viral Diarrhoea VirusIBR: Infectious Bovine RhinotracheitisHAV: Hepatitis A VirusCPV: Canine ParvovirusManufacturing StepHIV-1SindbisBVDVIBRHAVCPVA+1 Precipitationnd4.1>3.43.43.43.7Fraction IV Precipitation>4.6>7.1>4.2>5.74.26.0Pasteurization>6.7>6.4>4.2>5.44.04.0Overall>11.3>13.5>8.4>11.18.210.0

12.1 Mechanism Of Action

Human albumin accounts for more than half of the total protein in the plasma and represents about 10% of protein synthesis activity by the liver.The primary physiological function of albumin results from its contribution to plasma colloid oncotic pressure and transport function. Albumin stabilizes circulating blood volume and is a carrier of hormones, enzymes, medicinal products and toxins. Other physiological functions include antioxidant properties, free radical scavenging, and capillary membrane integrity.

12.3 Pharmacokinetics

Albumin is distributed throughout the extracellular space and more than 60% of the body albumin pool is located in the extravascular fluid compartment. Albumin has a circulating life span of 15-20 days, with a turnover of approximately 15 g per day. The balance between synthesis and breakdown is normally achieved by feedback regulation. Elimination is predominantly intracellular and due to lysosome proteases.In healthy subjects, less than 10% of infused albumin leaves the intravascular compartment during the first 2 hours following infusion. There is considerable individual variation in the effect of albumin on plasma volume.In some patients, the plasma volume can remain elevated for several hours. In critically ill patients, however, albumin can leak out of the vascular space in substantial amounts at an unpredictable rate.

15 References

  • 1.Finfer S, Bellomo R, Boyce N, et al. A comparison of albumin and saline for fluid resuscitation in the intensive care unit. N Engl J Med 2004;3650:2247-22562.Bunn F, Trivedi D, Ashraf S. Colloid solutions for fluid resuscitation. Cochrane Database of Systematic Reviews 2011, Issue 3. Art. No.: CD001319. DOI: 10.1002/14651858.CD001319.pub33.Powell-Tuck J, Gosling P, Lobo DN, et al. British Consensus Guidelines on Intravenous Fluid Therapy for Adult Surgical Patients. BAPEN; 2011. Available from: http://www.bapen.org.uk/pdfs/bapen_pubs/giftasup.pdf (Guideline Ref ID GIFTASUP2011)4.Rochwerg B, Alhazzani W, Sindi A, et al. Fluid resuscitation in sepsis: a systematic review and network meta-analysis. Ann Intern Med 2014;161(5):347-3555.Wiedermann CJ, Joannidis M. Albumin replacement in severe sepsis or septic shock. N Engl J Med 2014;371:83-846.Akech S, Gwer S, Idro R, et al. Volume expansion with albumin compared to gelofusine in children with severe malaria: results of a controlled trial. PLoS Clin Trials 2006; 5:0001-00117.Dellinger RP, Levy MM, Rhodes A, et al. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Critical Care Medicine, 2013; 41(2):580–6378.Perel P, Roberts I, Ker K. Colloids versus crystalloids for fluid resuscitation in critically ill patients. Cochrane Database of Systemic Reviews 2013, Issue 2.Art. No.CD000567. DOI:10.1002/14651858.CD000567.pub6.9.Runyon BA. Management of Adult Patients with Ascites Due to Cirrhosis: Update 2012. The American Association for the Study of Liver Diseases 2012. http://www.aasld.org/publications/practice-guidelines-0 [accessed 15 April 2016]10.EASL clinical practise guidelines on the management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome in cirrhosis. J Hepatol 2010; 53: 397–41711.Bernardi M, Carceni P, Navickis RJ, et al. Albumin infusion in patients undergoing large-volume paracentesis: a meta-analysis of randomized trials. Hepatology 2012;55:1172-118112.Sarma MS, Yachha SK, Bhatia V, et al. Safety, complications and outcome of large volume paracentesis with or without albumin therapy in children with severe ascites due to liver disease. J Hepatol 2015:63;1126-113213.Wiest R, Krag A, Gerbes A. Spontaneous Bacterial Peritonitis. Recent Guidelines and Beyond. Gut 2012; 61(2):297-31014.Pham TN, Cancio LC, Gibran NS. American Burn Association Practice Guidelines Burn Shock Resuscitation. J Burn Care Res 2008; 29(1):257-26615.Bircan Z, Kervancioglu M. Does albumin and furosemide therapy affect plasma volume in nephrotic children? Pediatr Nephrol 2001;16:497-49916.Dharmaraj R, Hari P, Bagga A. Randomized cross-over trial comparing albumin and frusemide infusions in nephrotic syndrome. Pediatr Nephrol 2009; 24(4):775-78217.Martin GS, Moss M, Wheeler AP, et al. A randomized, controlled trial of furosemide with or without albumin in hypoproteinemic patients with acute lung injury. Crit Care Med 2005;33(8):1681-168718.Uhlig C, Pedro L, Silva PL, et al. Albumin versus crystalloid solutions in patients with the acute respiratory distress syndrome: a systematic review and meta-analysis. Crit Care 2014, 18:R10 http://ccforum.com/content/18/1/R10 [accessed 02 November 2016]19.Quinlan GJ, Mumby S, Martin GS, et al. Albumin influences total plasma antioxidant capacity favorably in patients with acute lung injury. Crit Care Med 2004;32:755–75920.Wilkes MM, Navickis RJ, Sibbald WJ. Albumin versus hydroxyethyl starch in cardiopulmonary bypass surgery: a meta-analysis of postoperative bleeding. Ann Thorac Surg 2001;72(2):527-53421.Golab HD, Scohy TV, de Jong PL, et al. Relevance of colloid oncotic pressure regulation during neonatal and infant cardiopulmonary bypass: a prospective randomized study. Eur J Cardio-Thor Surg 2011; 39(6):886-89122.Hanart C, Khalife M, De Villé A, et al. Perioperative volume replacement in children undergoing cardiac surgery: Albumin versus hydroxyethyl starch 130/0.4. Crit Care Med 2009;37 (2): 696-701DOI: 10.1097/CCM.0b013e3181958c8123.Loeffelbein F, Zirell U, Benk C, et al. High colloid oncotic pressure priming of cardiopulmonary bypass in neonates and infants: implications on haemofiltration, weight gain and renal function. Eur J Cardio-Thor Surg 2008; 34(3):648-65224.Oliver WC Jr, Beynen FM, Nuttall GA, et al. Blood loss in infants and children for open heart operations: albumin 5% versus fresh-frozen plasma in the prime. Ann Thor Surg 2003;75(5):1506-151225.Yu K, Liu Y, Hei F, et al. Effect of different albumin concentrations in extracorporeal circuit prime on perioperative fluid status in young children. ASAIO Journal 2008; 54(5):463-46626.German Medical Association. Cross-Sectional Guidelines for Therapy with Blood Components and Plasma Derivatives. 4th revised and updated edition 2014. http://www.bundesaerztekammer.de/aerzte/medizin-ethik/wissenschaftlicher-beirat/veroeffentlichungen/haemotherapie-transfusionsmedizin/english/ [accessed 15 April 2016]

Storage And Handling

Storage and handlingDo not store above 30°C (86°F).Keep the vial stored in the outer carton in order to protect from light.Do not freeze.Do not use ALBUMINEX 5% after the expiration date which is stated on the carton and label after "EXP." The expiration date refers to the last day of that month.ALBUMINEX 5% should be inspected visually for particulate matter and discoloration prior to administration.U.S. federal law prohibits dispensing without prescription.

17 Patient Counseling Information

Ensure that patients to be treated with ALBUMINEX 5% are informed of the potential risks and benefits of its use for their clinical condition [see Warnings and Precautions (5)].Check that they are not known to be allergic to the product or its excipients [see Contraindications (4) and Description (11)].Make them aware of the symptoms of anaphylaxis [see Hypersensitivity (5.1)].Make them aware of the symptoms of potential circulatory overload [see Hypervolemia (5.2)].Inform patients that because ALBUMINEX 5% is derived from human blood plasma it may contain infectious agents that cause disease (e.g. viruses and, theoretically CJD agent) although the risk of infection from ALBUMINEX 5% has been reduced by the procedures used in donor selection and during manufacture [see Infectious Diseases (5.6) and Description (11)].

* Please review the disclaimer below.