Human Albumin Grifols

Description

Human Albumin Grifols 20% is a sterile aqueous solution intended for single-dose intravenous administration, containing 20% human albumin (weight/volume). This product is derived from pooled human plasma obtained through a cold alcohol fractionation method. Each gram of protein in the solution is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate. The colloid osmotic effect of Human Albumin Grifols 20% is approximately four times that of normal human plasma.

A liter of the solution contains 130 to 160 milliequivalents of sodium ion, and the aluminium content does not exceed 200 micrograms per liter throughout the product's shelf life. The formulation is preservative-free and is manufactured from Source Plasma collected at FDA-approved plasmapheresis centers in the United States. Additionally, the product undergoes a heating process at 60 °C for ten hours to mitigate the risk of viral transmission.

Uses and Indications

Human Albumin Grifols 20% is indicated for the treatment of various medical conditions, including hypovolemia, cardiopulmonary bypass procedures, acute nephrosis, hypoalbuminemia, ovarian hyperstimulation syndrome, neonatal hyperbilirubinemia, and adult respiratory distress syndrome (ARDS). Additionally, this drug is utilized for the prevention of central volume depletion following paracentesis in patients with cirrhotic ascites.

There are no teratogenic or nonteratogenic effects associated with the use of Human Albumin Grifols 20%.

Dosage and Administration

For intravenous use only, the dosage and infusion rate should be tailored to meet the individual requirements of the patient.

Indications and Doses:

Hypovolemia:

• Adults: An initial dose of 20 g is recommended, which includes patients undergoing renal dialysis.

• In cases of acute liver failure, an initial dose ranging from 12 to 25 g is advised.

Cardiopulmonary Bypass Procedures:

• Adults: An initial dose of 25 g should be administered.

Acute Nephrosis:

• Adults: A dose of 25 g should be given in conjunction with a diuretic once daily for a duration of 7 to 10 days.

Hypoalbuminemia:

• Adults: A total dose of 50 to 75 g is indicated.

• For pre- and post-operative hypoproteinemia, the same dosage of 50 to 75 g is recommended.

• In burn therapy, after the first 24 hours, an initial dose of 25 g should be administered, with subsequent adjustments made to maintain a plasma protein concentration of 2.5 g per 100 mL.

• For third space protein loss due to infection, an initial dose of 50 to 100 g is suggested.

Ovarian Hyperstimulation Syndrome:

• Adults: A dose of 50 g to 100 g should be infused over 4 hours, with repeat doses at intervals of 4 to 12 hours as necessary.

Neonatal Hyperbilirubinemia:

• Administer 1 g per kilogram of body weight prior to or during exchange transfusion.

Adult Respiratory Distress Syndrome (ARDS):

• Adults: An initial dose of 25 g should be infused over 30 minutes, with the option to repeat every 8 hours for up to 3 days if necessary.

Prevention of Central Volume Depletion After Paracentesis Due to Cirrhotic Ascites:

• Adults: Administer 8 g for every 1000 mL of ascitic fluid removed.

It is critical to avoid diluting the solution with sterile water for injection, as this may lead to hemolysis in recipients.

Contraindications

Use of this product is contraindicated in patients with hypersensitivity to albumin preparations or any of the excipients. Additionally, it should not be administered to individuals with severe anemia or cardiac failure when intravascular volume is normal or increased, due to the potential for exacerbating these conditions.

Warnings and Precautions

Suspicion of allergic or anaphylactic reactions necessitates the immediate discontinuation of the injection, followed by the implementation of appropriate medical treatment. Healthcare professionals should remain vigilant for signs of such reactions during administration.

Caution is advised regarding the potential for hypervolemia, particularly if the dosage and rate of infusion are not appropriately adjusted to the patient's volume status. This condition may pose significant risks in patients with pre-existing conditions where hypervolemia and its consequences, or hemodilution, could exacerbate their clinical situation.

When administering concentrated albumin, it is imperative to ensure that the patient is adequately hydrated. This precaution helps mitigate the risk of complications associated with the infusion.

Monitoring is essential during the administration of albumin. Healthcare providers should regularly assess electrolytes, coagulation and hematology parameters, as well as the patient's hemodynamic status to ensure safe and effective use of the product.

It is critical to note that this product should not be diluted with sterile water for injection, as this could compromise its efficacy and safety.

Additionally, this product is derived from human plasma and may contain infectious agents, including viruses and, theoretically, the agent responsible for Creutzfeldt-Jakob disease. Healthcare professionals should consider this risk when prescribing and administering the product.

Side Effects

Patients receiving this treatment may experience common adverse reactions, including anaphylactoid type reactions. In the event of suspected allergic or anaphylactic reactions, immediate discontinuation of the injection is required, along with the implementation of appropriate medical treatment.

Warnings associated with this product include the potential for hypervolemia, which may occur if the dosage and rate of infusion are not adjusted according to the patient's volume status. Caution is advised in patients with conditions where hypervolemia and its consequences, or hemodilution, could pose a special risk. When administering concentrated albumin, it is essential to ensure adequate hydration of the patient. Additionally, monitoring of electrolytes, coagulation and hematology parameters, and hemodynamic status is recommended during administration.

It is important to note that this product is derived from human plasma and may contain infectious agents, including viruses and, theoretically, the agent responsible for Creutzfeldt-Jakob disease.

Contraindications for this treatment include hypersensitivity to albumin preparations or any of the excipients, as well as severe anemia or cardiac failure in patients with normal or increased intravascular volume.

Drug Interactions

Human Albumin Grifols 20% should not be mixed with other medicinal products due to the potential for adverse interactions. This precaution is critical to ensure the safety and efficacy of the treatment, as mixing may lead to unpredictable pharmacological effects or compromise the integrity of the albumin solution. It is advised that healthcare professionals adhere strictly to this guideline to avoid any complications associated with drug interactions.

Biosimilarity

Human Albumin Grifols is the FDA‑licensed reference product against which biosimilar and interchangeable products are compared.

Packaging & NDC

The table below lists all NDC Code configurations of Human Albumin Grifols (albumin (human)) originator presentations. Columns show Packaging, Form, and Strength.

Pediatric Use

Pediatric patients should only be treated with this medication if clearly needed, as there are no available human or animal data to support its use in this population. Caution is advised when considering treatment options for children, infants, and adolescents.

Geriatric Use

Elderly patients should be prescribed this medication with caution, as there is a lack of human or animal data to support its safety and efficacy in this population. It is recommended that this medication be used only when clearly needed, taking into consideration the potential risks versus benefits.

Healthcare providers are advised to closely monitor geriatric patients for any adverse effects or complications that may arise during treatment, given the absence of specific data regarding this demographic. Careful assessment and individualized treatment plans are essential to ensure the safety of elderly patients receiving this medication.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with Human Albumin Grifols 20%. It is not known whether Human Albumin Grifols 20% can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Therefore, Human Albumin Grifols 20% should be given to a pregnant woman only if clearly needed. Healthcare professionals are advised to weigh the potential benefits against the risks when considering the use of this product in pregnant patients.

Lactation

There are no available data on the excretion of this medication in human or animal breast milk. Therefore, the use of this medication in lactating mothers should be considered only if clearly needed. Healthcare professionals should weigh the potential benefits against any unknown risks to the breastfed infant.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

Nonclinical Toxicology

Pregnancy Category C has been assigned to Human Albumin Grifols 20%. Animal reproduction studies have not been conducted, and there is no available data regarding the potential for Human Albumin Grifols 20% to cause fetal harm when administered to a pregnant woman or to affect reproductive capacity. Therefore, Human Albumin Grifols 20% should be administered to pregnant women only if clearly needed.

No nonclinical toxicology data has been provided. Additionally, animal reproduction studies have not been performed with Human Albumin Grifols 20%. There is no evidence of teratogenic effects in either human or animal studies, and the absence of data necessitates caution in its use during pregnancy.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with Human Albumin Grifols 20%. These include allergic reactions, such as anaphylaxis, cardiovascular overload, increased blood pressure, raised venous pressure, and pulmonary edema.

As a derivative of human plasma, Human Albumin Grifols 20% may contain infectious agents that can cause disease, including viruses and, theoretically, the agent responsible for Creutzfeldt-Jakob disease (CJD). However, the risk of transmission of infectious agents has been mitigated through measures such as screening plasma donors for prior exposure to specific viruses, testing the donated plasma for certain viral agents, and implementing inactivation and/or removal processes for certain viruses during manufacturing.

Patient Counseling

Healthcare providers should inform patients receiving Human Albumin Grifols 20% about the associated risks and benefits of its use. It is essential for patients to understand the importance of promptly reporting any signs and symptoms that may indicate adverse reactions. Specifically, patients should be advised to immediately notify their physician if they experience allergic or anaphylactic reactions, cardiovascular overload symptoms such as headache, dyspnea, or jugular venous distention, or signs of increased blood pressure, raised venous pressure, and pulmonary edema.

Patients should also be made aware that Human Albumin Grifols 20% is derived from human plasma and may contain infectious agents that could potentially cause disease, including viruses and, theoretically, the agent responsible for Creutzfeldt-Jakob disease (CJD). However, it is important to communicate that the risk of transmission of infectious agents through Human Albumin Grifols 20% has been significantly reduced through several safety measures. These measures include screening plasma donors for prior exposure to certain viruses, testing the donated plasma for specific viral agents, and employing inactivation and/or removal processes for certain viruses during manufacturing.

Healthcare providers should encourage an open dialogue between the patient and physician regarding the risks and benefits of Human Albumin Grifols 20%, ensuring that patients feel informed and supported in their treatment decisions.

Storage and Handling

Human Albumin Grifols 20% is supplied in single-use vials that are individually laser etched for identification. Each vial is designed for one-time use to ensure product integrity and safety.

For optimal storage, Human Albumin Grifols 20% should be maintained at a temperature not exceeding 30 °C. The product is stable for a period of three years under these conditions. It is essential to protect the vials from freezing to preserve the quality and efficacy of the albumin solution.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Human Albumin Grifols as submitted by GRIFOLS USA, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)