ALBUTEIN- albumin (human) injection, solution
GRIFOLS USA, LLC
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ALBUTEIN FlexBag 25% safely and effectively. See full prescribing information for ALBUTEIN FlexBag 25%.
ALBUTEIN FlexBag 25% (albumin [human] U.S.P.)
Initial U.S. Approval: 1978
INDICATIONS AND USAGE
ALBUTEIN 25% is an albumin solution indicated for:
DOSAGE AND ADMINISTRATION
For Intravenous Use Only
Dosage and infusion rate should be adjusted to the patient's individual requirements.
Do not dilute with sterile water for injection as this may cause hemolysis in recipients. (5.7)
DOSAGE FORMS AND STRENGTHS
Albutein 25% is a solution containing 250 g per L of total protein of which at least 95% is human albumin. (3)
WARNINGS AND PRECAUTIONS
The most common adverse reactions are anaphylactoid type reactions. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Grifols Biologicals LLC at 1-888-GRIFOLS (1-888-474-3657) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.2 Cardiopulmonary Bypass Procedures (Treatment Adjunct)
1.3 Acute Nephrosis (Treatment Adjunct)
1.5 Ovarian Hyperstimulation Syndrome
1.6 Neonatal hyperbilirubinemia
1.7 Adult Respiratory Distress Syndrome (ARDS) (Treatment Adjunct)
1.8 Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites (Treatment Adjunct)
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
5 WARNINGS AND PRECAUTIONS
5.4 Electrolyte Imbalance
5.5 Coagulation Abnormalities
5.6 Laboratory Monitoring
5.7 Application Precautions
5.8 Transmissible Infectious Agents
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post-marketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.4 Pediatric Use
8.5 Geriatric Use
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
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 25% can be used in such cases.1
ALBUTEIN 25% may be of value in the treatment of shock or hypotension in renal dialysis patients.1
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
ALBUTEIN 25% may be used to treat peripheral edema in patients with acute nephrosis who are refractory to cyclophosphamide, corticosteroid therapy or diuretics.1,2,7
ALBUTEIN 25% 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 25% 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 25% 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 25% 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
ALBUTEIN 25% may be used as a plasma volume expander in fluid management relating to severe forms of ovarian hyperstimulation syndrome.16,17
ALBUTEIN 25% 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
ALBUTEIN 25% infusions may be indicated in conjunction with diuretics to correct fluid overload and hypoproteinemia associated with ARDS.6,21
For Intravenous Use Only
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.
|Hypovolemia||Adults: Initial dose of 25 g.
If hemodynamic stability is not achieved within 15 to 30 minutes, an additional dose may be given.
Hemodilution may follow administration of ALBUTIEN 25%. Anemia resulting from hemorrhage should be corrected by administration of compatible red blood cells or compatible whole blood.
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.
|Cardiopulmonary bypass procedures||Adults: Initial dose of 25 g. Additional amounts may be administered as clinically indicated.|
|Acute nephrosis||Adults: 25 g together with diuretic once a day for 7 - 10 days.|
|Hypoalbuminemia||Adults: 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: 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.
|Ovarian hyperstimulation syndrome||Adults: 50 g to 100 g over 4 hours and repeated at 4-12 hour intervals as necessary, when infusion of normal saline fails to achieve or maintain hemodynamic stability and urine output.|
|Neonatal hyperbilirubinemia||1 g per kilogram body weight prior to or during exchange transfusion.|
|Adult respiratory distress syndrome (ARDS)||Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if necessary.|
|Prevention of central volume depletion after paracentesis due to cirrhotic ascites||Adults: 8 g for every 1000 mL of ascitic fluid removed.|
Intravenous use only
CAUTION: Do not use bags in series connections. Such use could result in air embolism due to residual air being drawn from the primary bag before the administration of the fluid from the secondary bag is complete.
ALBUTEIN 25% is a solution containing 250 g per L of total protein of which at least 95% is human albumin.
Suspicion of allergic or anaphylactic reactions requires 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. 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:
The colloid-osmotic effect of human albumin 25% is approximately five 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.
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.
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).
Monitor regularly hemodynamic parameters during administration of ALBUTEIN 25%; this may include:
ALBUTEIN 25% 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)].
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 and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD have ever been identified for ALBUTEIN 25%.
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 25% 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.
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:
There is no data with ALBUTEIN 25% use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with ALBUTEIN 25%. It is not known whether ALBUTEIN 25% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ALBUTEIN 25% should be given to a pregnant woman only if clearly needed. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
There is no information regarding the presence of ALBUTEIN 25% in human milk, the effect on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ALBUTEIN 25% and any potential adverse effects on the breastfed infant from ALBUTEIN 25%.
ALBUTEIN 25% is a sterile, aqueous solution for single dose intravenous administration containing 25% human albumin (weight/volume). ALBUTEIN 25% 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 25% is approximately five times that of normal human plasma. A liter of ALBUTEIN 25% 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 25% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 25% is heated at 60 °C for ten hours, a process that has the capacity to inactivate viruses.
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. Human Albumin 25% has a corresponding hyperoncotic effect.
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.
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.
ALBUTEIN FlexBag 25% is supplied in a single-dose, latex-free, flexible containers, free of polyvinyl chloride (PVC), diethylhexyl phthalate (DEHP), or other plasticizers. The protective overwrap on each container is also latex-free, and contains no chloride, PVC or plasticizers. Each container is individually laser-etched with at least the lot number and expiration date.
The following package sizes of ALBUTEIN FlexBag 25% are available in multipacks of 5 FlexBags/carton:
Carton NDC FlexBag NDC FlexBags Fill Size Grams Protein
68516-5216-9 68516-5216-7 5 50 mL 12.5 g
68516-5216-0 68516-5216-8 5 100 mL 25 g
ALBUTEIN FlexBag 25%, in flexible container, is stable for two years provided the storage temperature does not exceed 30 °C. Protect from freezing. Keep the overwrap intact.
This product is usually given in a hospital setting.
Inform patients being treated with ALBUTEIN 25% about the risks and benefits of its use [see Adverse Reactions (6)].
Inform patients to immediately report the following signs and symptoms to their physician:
Inform patients that ALBUTEIN 25% 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 25% 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 introduction of steps with capacity for the inactivation and/or removal of certain viruses during the manufacturing process [see Warnings and Precautions (5.8)].
Grifols Biologicals LLC
5555 Valley Boulevard
Los Angeles, CA 90032, U.S.A.
U. S. License No. 1694
Principal Display Panel – 5 x 100 mL Container Label
Albumin (Human) U.S.P.
ALBUTEIN FlexBag™ 25%
Solution 25 g 100 mL
5 x 100 mL Single-Dose Containers
Store at temperatures not exceeding 30°C. Do not allow to freeze. Keep the overwrap intact.
Grifols Biologicals LLC
Los Angeles, CA 90032, USA
U.S. License No. 1694
Principal Display Panel - 100 mL Bag Label
Albumin (Human) U.S.P.
ALBUTEIN FlexBag™ 25%
25 g / 100 mL
Contents: Each 100 ml contains 25 grams Albumin (Human) in aqueous diluent and is osmotically equivalent to 500 ml of plasma. Sodium range is 130-160 mEq/L. Stabilized with sodium caprylate and sodium acetyltryptophanate. Contains no preservatives. Heat-treated at 60 °C for 10 hours.
Instructions: See accompanying Full Prescribing Information.
Precautions: Single-dose container for intravenous administration. Prior to administration, check bag for leaks by squeezing firmly. If leaks are found, discard bag as sterility may be compromised. Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered. Discard any unused contents and administration devices after use.
Store at temperatures not exceeding 30 °C. Do not allow to freeze. Keep the overwrap intact.
Grifols Biologicals LLC
Los Angeles, CA 90032, USA
U.S. License No. 1694
albumin (human) injection, solution
|Labeler - GRIFOLS USA, LLC (048987452)|
|Grifols Biologicals LLC||092694538||manufacture(68516-5216)|
|Grifols Biologicals LLC||121076871||manufacture(68516-5216)|