Kedbumin

Description

KEDBUMIN is a sterile, aqueous solution intended for single dose intravenous administration, containing 0.25 g per mL of human albumin. It appears as a clear, slightly viscous liquid, which may have a yellow, amber, or green tint. The formulation is stabilized by the inclusion of 0.08 mmol of sodium caprylate and 0.08 mmol of sodium acetyltryptophan per gram of albumin. Each liter of KEDBUMIN contains 130-160 mEq of sodium ion and up to 200 μg of aluminum. The product is free from preservatives and is subjected to heating for ten hours at 60 °C (140°F).

Uses and Indications

KEDBUMIN is indicated for the treatment of hypovolemia and hypoalbuminemia. It is also indicated for the prevention of central volume depletion following paracentesis in patients with cirrhotic ascites. Additionally, KEDBUMIN is utilized in the management of ovarian hyperstimulation syndrome (OHSS) and adult respiratory distress syndrome (ARDS).

This drug is appropriate for patients with burns and for those undergoing long-term hemodialysis who may not tolerate substantial volumes of salt solution. KEDBUMIN may also be used for priming as part of cardiopulmonary bypass fluids.

There are no teratogenic or nonteratogenic effects associated with KEDBUMIN.

Dosage and Administration

KEDBUMIN is administered exclusively via intravenous route. Prior to administration, KEDBUMIN may be diluted with either 5% glucose or 0.9% sodium chloride to achieve the desired concentration.

The daily dosage limit for KEDBUMIN should not exceed 2 grams per kilogram of body weight. The following dosage recommendations are provided based on specific indications:

Hypovolemia: For adults, an initial dose of 25 grams is suggested.

Hypoalbuminemia: The recommended dosage ranges from 50 to 75 grams.

Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites: For adults, administer 6 to 8 grams for every 1000 mL of ascitic fluid removed.

Ovarian Hyperstimulation Syndrome (OHSS): In adults, a dose of 50 to 100 grams should be administered over 4 hours, with the possibility of repeating at intervals of 4 to 12 hours as necessary. A single infusion of 10 to 50 grams may also be considered.

Acute Respiratory Distress Syndrome (ARDS): For adults, administer 25 grams over a period of 30 minutes, with the option to repeat every 8 hours for up to 3 days if necessary.

Burns: The dosage should be determined based on direct observation of vital signs or measurement of either plasma oncotic pressure or protein content.

Hemodialysis: A standard dose of 100 mL is recommended.

Cardiopulmonary Bypass: The dosage is estimated by calculating the difference between the desired and actual total serum protein concentration, multiplied by the estimated plasma volume (approximately 40 mL per kg) and then multiplied by 2.

Healthcare professionals should ensure adherence to these guidelines to optimize patient outcomes while minimizing the risk of adverse effects.

Contraindications

Use is contraindicated in patients with severe anemia or heart failure when normal or increased intravascular volume is present, due to the potential for exacerbating these conditions. Additionally, hypersensitivity to albumin, its excipients, or components of the container is a contraindication, as it may lead to serious allergic reactions.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.

Risk of Transmission of Infectious Agents There is a potential risk for the transmission of infectious agents. It is imperative that all necessary precautions are taken to minimize this risk during administration (refer to section 5.1).

Caution in Patients with Hypervolemia Special caution is advised in patients who may experience hypervolemia and its associated complications, as well as in cases where hemodilution could pose a significant risk (see section 5.2).

Dilution Guidelines It is critical to note that this product should not be diluted with water for injection. Adhering to this guideline is essential to ensure the safety and efficacy of the treatment (refer to section 5.2).

Healthcare professionals are encouraged to monitor patients closely and consider these factors to ensure safe and effective use of the product.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Common adverse reactions observed include fever, chills, rash, nausea, vomiting, tachycardia, and hypotension.

In addition to these common reactions, there are important considerations regarding the safety profile of the product. There is a risk of transmission of infectious agents, which necessitates caution in patients with hypervolemia and its potential consequences, as well as in those with hemodilution that could pose a special risk.

Severe anemia or heart failure may occur in patients who present with normal or increased intravascular volume. Furthermore, hypersensitivity reactions to albumin, its excipients, or components of the container have been reported.

Hypervolemia is a potential risk if the dosage and rate of infusion exceed recommended levels. At the first clinical sign of circulatory overload—such as headache, dyspnea, jugular venous congestion, increased blood pressure, raised central venous pressure, or pulmonary edema—the infusion should be promptly stopped. Hemodynamic parameters must be carefully monitored, and interventions such as diuresis or adjustments to cardiac output should be implemented based on the severity of the clinical situation.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Biosimilarity

Kedbumin 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 Kedbumin (albumin (human)) originator presentations. Columns show Packaging, Form, and Strength.

Pediatric Use

The adult dose of KEDBUMIN® may be administered to pediatric patients aged 12 to 16 years. For children under 12 years of age, the use of KEDBUMIN® has not been clinically evaluated, and caution is advised. When considering administration in this younger population, the dosage should be adjusted based on the clinical state and body weight of the individual. Typically, a dose ranging from one-fourth to one-half of the adult dose may be appropriate. Additionally, the usual rate of administration in children should be one-fourth of the adult rate. Physicians are encouraged to carefully weigh the risks and benefits of KEDBUMIN® when treating pediatric patients.

Geriatric Use

Elderly patients may not have specific geriatric use information available in the prescribing information. The document does not provide recommended age considerations, dosage adjustments, safety concerns, or special precautions for this population. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and potential age-related physiological changes. Monitoring for efficacy and safety is advised, as is the consideration of any comorbidities that may affect treatment outcomes in elderly individuals.

Pregnancy

There are no available human or animal data to indicate the presence or absence of drug-associated risk with KEDBUMIN® during pregnancy. As such, it is not known whether KEDBUMIN® can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity.

Healthcare professionals should consider the potential risks and benefits of KEDBUMIN® when prescribing to pregnant patients. Women of childbearing potential should be advised to inform their healthcare provider if they are pregnant, plan to become pregnant, or are breastfeeding.

Lactation

It is not known whether KEDBUMIN® is excreted in human milk. There are no available data from human or animal studies to indicate the presence or absence of drug-associated risks for lactating mothers or breastfed infants. Additionally, it is unclear whether KEDBUMIN® can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Therefore, healthcare professionals should exercise caution when considering the use of KEDBUMIN® in lactating mothers.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular monitoring of renal function may be warranted in patients with reduced kidney function 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 overdosage information, it is essential for healthcare professionals to remain vigilant and consider general principles of management in cases of suspected overdose.

Healthcare providers should monitor patients closely for any signs or symptoms that may arise from an overdose of the medication. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, it is recommended that healthcare professionals initiate supportive care immediately. This may involve maintaining the patient's airway, breathing, and circulation, as well as providing symptomatic treatment as necessary.

Additionally, contacting a poison control center or a medical toxicologist for guidance on specific management strategies is advisable. It is crucial to gather as much information as possible regarding the substance involved, the amount taken, and the time of ingestion to facilitate appropriate treatment decisions.

Documentation of the incident and ongoing monitoring of the patient’s condition are also critical components of effective management in cases of overdose.

Nonclinical Toxicology

The available data regarding the teratogenic effects of KEDBUMIN® indicate that there are no human or animal studies to assess the potential risk associated with its use during pregnancy. Consequently, it remains unclear whether KEDBUMIN® may cause fetal harm when administered to a pregnant woman or if it could impact reproductive capacity.

In terms of non-teratogenic effects, there is also a lack of human or animal data to determine any associated risks. It is unknown whether KEDBUMIN® is excreted in milk, which further complicates the assessment of its safety during lactation.

No specific information is provided in the insert regarding nonclinical toxicology or animal pharmacology and toxicology, limiting the understanding of the drug's safety profile in these areas.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. The most frequently observed adverse reactions include fever, chills, rash, nausea, vomiting, tachycardia, and hypotension. Instances of hypersensitivity or allergic reactions have also been documented, with some cases progressing to severe anaphylaxis; therefore, it is recommended that epinephrine be readily available to manage any acute hypersensitivity reactions.

Additionally, there is a recognized risk of potentially fatal hemolysis and acute renal failure associated with the use of Sterile Water for Injection as a diluent for 25% albumin. As albumin is derived from human blood, it carries an extremely remote risk for the transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD), based on effective donor screening and manufacturing processes. While there is a theoretical risk for the transmission of Creutzfeldt-Jakob disease (CJD), no cases of transmission of viral diseases, CJD, or vCJD have been identified for licensed albumin.

Healthcare providers are encouraged to report any infections suspected to be transmitted by this product to Kedrion Biopharma, Inc. at 1-855-3KDRION (1-855-353-7466).

Patient Counseling

Healthcare providers should inform patients being treated with KEDBUMIN® about the potential risks and benefits associated with its use. It is essential to discuss the importance of monitoring for any allergic symptoms or signs of circulatory overload, which may include skin rashes, hives, itching, breathing difficulties, coughing, nausea, vomiting, a fall in blood pressure, or an increased heart rate. Patients should be advised to discontinue the use of KEDBUMIN® immediately if any of these symptoms occur.

Additionally, healthcare providers should explain that KEDBUMIN® is derived from human plasma and may contain infectious agents that could potentially cause disease, such as viruses and the agents responsible for variant Creutzfeldt-Jakob disease (vCJD) and, theoretically, Creutzfeldt-Jakob disease (CJD). It is important to reassure patients that the risk of transmitting an infectious agent through KEDBUMIN® has been mitigated by implementing measures such as screening plasma donors for prior exposure to certain viruses, testing the donated plasma for specific virus infections, and employing processes to inactivate and/or remove certain viruses during the manufacturing process.

Storage and Handling

KEDBUMIN® is supplied in vials, with specific handling and storage requirements to ensure product integrity. It is essential to adhere to the expiration date indicated on the carton and label, following the "EXP." notation, which signifies the last day of the specified month.

For optimal storage, KEDBUMIN® must be kept at a temperature not exceeding 30°C (86°F). The vial should remain in its outer carton to provide protection from light exposure. Additionally, it is critical to avoid freezing the product, as this may compromise its efficacy.

Additional Clinical Information

Patients receiving KEDBUMIN® should be informed about the potential risks and benefits associated with its use. Clinicians should advise patients to discontinue the treatment immediately if they experience any allergic symptoms or signs of circulatory overload, such as skin rashes, hives, itching, breathing difficulties, coughing, nausea, vomiting, a drop in blood pressure, or increased heart rate.

It is important to communicate that KEDBUMIN® is derived from human plasma and may carry infectious agents that could cause disease, including viruses and the vCJD agent. However, the risk of transmission has been mitigated through measures such as screening plasma donors, testing for certain viral infections, and employing virus inactivation or removal techniques during manufacturing. KEDBUMIN® is administered exclusively via intravenous route.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Kedbumin as submitted by Kedrion S. p. A. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)