Alburel

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Alburel

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Alburel

Quick Facts

Property Description
Active Ingredient Human Albumin (INN)
Form Solution for Infusion
Pharmacological Class Plasma Expander / Colloid
Common Use Stabilizing circulating blood volume
Origin Human-derived Biologic

What Type of Medicine is Alburel (Human Albumin)?

Alburel is defined as a biologic pharmaceutical preparation that belongs to the pharmacological class of Plasma Expanders and Colloids. Its active component is Human Albumin, a naturally occurring protein purified from large pools of donated human plasma. Products derived from human blood components like this are considered critical for essential therapies. This type of large-molecule solution is clinically recognized to be significantly effective at volume restoration compared to simpler electrolyte solutions.

As a colloid, the large size of the Human Albumin molecule prevents it from rapidly escaping the blood vessels, thereby ensuring that the oncotic pressure—the critical force holding fluid within the circulation—is maintained for a sustained period.


Composition and Form: The Origin and Presentation of Alburel

The active substance of Alburel is pure Human Albumin protein, which is obtained exclusively from screened human plasma and is supplied as a sterile Solution for Infusion, intended for Intravenous (I.V.) administration. The preparation includes stabilizers like N-acetyl-DL-tryptophan and caprylic acid, along with minimal electrolytes like Sodium and Potassium, dissolved in an aqueous vehicle. The manufacturing process for this human-derived biologic involves stringent viral inactivation steps, such as pasteurization, to ensure the product’s purity and safety. Products containing Human Albumin are restricted to prescription-only use and are typically administered in a supervised clinical setting.


What is the General Purpose of This Plasma Expander?

The overarching purpose of Alburel is to quickly and effectively restore and maintain the circulating blood volume when a patient is experiencing significant volume depletion due to fluid or protein loss, such as following surgery or trauma. By rapidly stabilizing the circulatory volume and improving oncotic pressure, the medication ensures that essential organs receive sufficient blood flow. Furthermore, the infused Human Albumin supports the body's internal processes by acting as a transport protein for various important molecules throughout the bloodstream.

Regulatory References

  1. World Health Organization (WHO) Model List of Essential Medicines
  2. WHO Model List of Essential Medicines

What side effects are possible with Alburel?

Possible Side Effects and Safety Information

The safety profile for Human Albumin preparations like Alburel is based on regulatory classifications of adverse reactions by system-organ class and frequency, as documented by government health authorities. Reactions are often classified using frequency bands such as Rare and Very Rare.

Rare reactions (occurring in 1 to 10 users in 10,000) are typically mild. These include flushing, pyrexia (fever), urticaria (hives), and nausea.

Serious Adverse Reactions

Two critical risks are explicitly highlighted in regulatory documents. The first is Anaphylactic Shock or Severe Hypersensitivity, a life-threatening allergic reaction requiring immediate discontinuation of the infusion. The second is Circulatory Overload (Hypervolaemia), a serious risk linked to the medicine's plasma-expanding function. Signs of hypervolaemia, such as dyspnea (shortness of breath), headache, and increased blood pressure, require the infusion to be stopped immediately.

Safety Restrictions and Special Populations

The medicine is Contraindicated in individuals with known hypersensitivity to albumin or its excipients. Caution is required in patients with specific pre-existing conditions where fluid expansion could pose a special risk, including cardiac insufficiency, pulmonary oedema, and severe anaemia. Regarding use in pregnancy and lactation, while controlled studies are absent, clinical experience suggests no harmful effects are expected. Patient monitoring for electrolyte balance is necessary during administration, and regulatory documents also address the extremely remote risk of transmitting infectious agents inherent to human-derived biologics.

Overdose and Emergency Response

Overdose with Alburel is officially documented as resulting in Hypervolaemia or Circulatory Overload, which occurs when the infusion rate or dose is too high relative to the patient's existing circulatory status. Regulator-mandated action is required at the first manifestation of this condition.


The clinical signs indicating the onset of cardiovascular overload include headache, dyspnoea (difficult breathing), increased blood pressure, and jugular vein congestion. These symptoms serve as the official triggers for emergency intervention. The regulatory documents explicitly state that the infusion must be slowed or stopped immediately by the administering professional upon the appearance of these first clinical signs. This action is critical to prevent progression to a severe outcome.


A severe, life-threatening consequence of uncontrolled Hypervolaemia is pulmonary oedema. Following the immediate cessation of the infusion, management is purely supportive. While no specific antidote is known, official labeling requires careful monitoring of haemodynamic parameters, including arterial blood pressure, central venous pressure, and haematocrit. A higher risk of severe consequences from circulatory overload is noted for patients with pre-existing conditions such as decompensated cardiac insufficiency or severe anaemia, as stated in the prescribing information.

Therapeutic Uses of Alburel

What Alburel Treats: Main Uses and Benefits

Alburel (Human Albumin) is applied across domains where additional symptomatic support is needed to help manage symptoms related to systemic imbalance. It is relevant in contexts involving heightened systemic burden and is commonly used across conditions characterized by periods of heightened symptoms, involving episodic or fluctuating manifestations.


Key Areas of Symptom Relief

Alburel is commonly used across conditions presenting with acute episodes characterized by symptoms related to heightened physiological activity. It plays a role in managing symptoms associated with acute or episodic changes, offering supportive relief when symptoms create noticeable functional strain.

“It provides support that helps ease the overall symptom burden and may assist with supporting general well-being during symptomatic phases.”

The medication is relevant in contexts involving certain distressing symptoms that interfere with daily functioning. This support helps patients cope more steadily with symptom fluctuations and assists with maintaining functional stability when symptoms interfere with routine activities.

Quick Fact: Support for Functional Stability


Eligibility and Restrictions for Use

The official regulatory profile for Alburel (Human Albumin) strictly defines who can and cannot use the medicine based on absolute prohibitions and conditional patient status.

Absolute Contraindications

Alburel is strictly contraindicated for any individual with a known history of hypersensitivity to human albumin preparations or to any excipient. Use is also prohibited in patients who have severe anemia combined with cardiac failure and normal or increased intravascular volume.

Restricted and Conditional Use

The medicine requires special caution and monitoring in populations where the risk of hypervolemia (fluid overload) or hemodilution is a concern. These risk conditions include decompensated cardiac insufficiency (heart failure), pulmonary edema, hypertension, esophageal varices, and renal anuria.

Age and Reproductive Status

The medicine should only be administered to pediatric patients if clearly needed. Similarly, use during pregnancy and lactation is restricted to situations where the need is clearly established, due to a lack of controlled clinical safety data. Insufficient data is available to define specific differences in response for geriatric patients.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The officially documented interaction profile for Alburel (Human Albumin) is defined by mandatory physical and chemical incompatibility constraints rather than typical drug-drug metabolic interactions. Regulatory agencies state that, as a large-molecule colloid, the product does not exhibit clinically significant interactions mediated by liver enzymes or drug transporters.

The most stringent restriction relates to solution preparation: Alburel must not be diluted with Water for Injection. This mandatory procedural rule exists because mixing with hypotonic solutions creates an immediate osmotic risk leading to potential hemolysis (red blood cell destruction) in the recipient, as detailed in official prescribing information.

Additionally, the solution is subject to specific co-administration prohibitions. It must not be combined with protein hydrolysates or any solution containing alcohol in the same container or infusion line due to the risk of chemical instability or precipitation. To comply with these constraints and ensure product integrity, Alburel requires mandatory separation of administration from all other medicinal products. No interactions with food, dietary supplements, or herbal products are documented in official regulatory labels.

Mechanism of Action

How Alburel Works: Mechanism of Action

Alburel (Human Albumin) is an exogenous protein administered directly into the bloodstream, where it targets the intravascular compartment. Its primary mechanism involves acting as a Colloid Osmotic Agent. Due to its high concentration and molecular size, the protein exerts Colloid Osmotic Pressure (COP), a physical force that draws solvent (water and crystalloids) from the surrounding tissues (interstitial space) into the blood vessels. This fluid shift initiates a cascade resulting in the direct expansion of the circulating blood volume.

This volume expansion directly influences mechanisms regulating circulatory hemodynamics. By elevating the volume returning to the heart (venous return), the mechanism contributes to enhanced cardiac preload and increased cardiac output. The physiological consequence is the maintenance of systemic blood volume and pressure and sustained blood flow to tissues.

Additionally, Albumin contains multiple binding sites, enabling the transport and binding of various endogenous substances, including hormones, fatty acids, bilirubin, and certain pharmacological compounds. This secondary function influences systemic protein equilibrium.

Dosage and Administration Information

Route and Form

Alburel is strictly administered as a Solution for Infusion via the Intravenous (IV) route. This ensures the medication is delivered directly into the circulation and is a practice limited to supervised clinical environments.

Dosing and Frequency Principles

The dosage is highly individualized and determined by the patient’s acute circulatory need and hemodynamic stability, rather than a predetermined schedule. For acute volume depletion, a typical initial dose may be administered, with the potential for repeat administration after 15 to 30 minutes if the immediate volume effect is insufficient. The maximum daily dose for any patient is restricted to 2 g/kg of body weight.

Preparation and Handling

The solution must be visually inspected prior to use and is permitted to be administered either undiluted or diluted in approved isotonic solutions, such as 0.9% Sodium Chloride or 5% Glucose. It is important to avoid dilution with sterile water for injection to prevent hemolysis. If large volumes are needed, the product is typically warmed to room or body temperature before infusion.

Population and Duration

Dosing for pediatric patients is determined based on body weight, with amounts typically ranging from 0.5 to 1 g/kg. Alburel is fundamentally intended for short-term volume support, though some therapeutic courses may be defined for a duration of up to 10 consecutive days.

Recent Clinical Evidence

Overview of Studies

Alburel (Human Albumin) was studied for several conditions where systemic or functional imbalance was present. Research primarily examined the approach to managing circulating fluid volume. The research base relies mainly on Randomized Controlled Trials (RCTs), where Alburel's role is often compared against other volume-expanding fluids like saline, as well as comprehensive meta-analyses that combine data from multiple clinical trials.


Evidence in Acute Volume Depletion and Shock

Research has extensively explored the use of Alburel as part of fluid resuscitation in critically ill adults. Studies monitored high-level endpoints such as all-cause mortality over 28 and 90 days, immediate hemodynamic stability, and the necessary volume of other resuscitation fluids. Short-term volume expansion outcomes showed patterns related to volume expansion in Alburel groups that were similar to those receiving crystalloid solutions. However, when comparing overall survival, research described mixed findings or patterns that were not consistently different between the groups studied. What remains uncertain is whether research describes a consistent pattern of difference in survival outcomes compared to other standard fluids across all patient groups with shock.


Evidence in Liver Disease and Special Populations

For patients with liver cirrhosis, RCTs examined the use of Alburel for preventing post-procedure complications following large-volume fluid removal (paracentesis). The main outcomes measured were the prevention of Paracentesis-Induced Circulatory Dysfunction (PICD) and the occurrence of electrolyte changes. Research reports describe patterns observed where Alburel was associated with a reduced frequency of PICD and hyponatremia. While a large volume of research exists, long-term effects are not fully characterized, and there is limited information on long-term survival or recurrence rates. Additionally, research on severe burns and in critically ill patients based on their initial protein status (hypoalbuminaemia) provides context but not individual predictions on outcomes.

Frequently Asked Questions (FAQ)

Common questions about Alburel (FAQ)

Q: What is Alburel mainly used for according to the product label?

Official product information describes the main approved use of Alburel as restoring and maintaining circulating blood volume. This therapy is indicated when a significant deficiency in volume has been demonstrated in a patient.


Q: Is Alburel a type of antibiotic or a pain reliever?

Alburel is not an antibiotic or a pain reliever. It is classified as a plasma volume expander, or a colloid. Its active ingredient is Human Albumin, which is a protein derived from human plasma and works to increase blood volume.


Q: Does Alburel have to build up in the body before it starts working?

No, Alburel does not need to build up in the body. Because it is delivered directly into the bloodstream as an intravenous solution, its action of expanding plasma volume typically begins rapidly. The official product information indicates this effect can often be seen within 15 minutes of administration.


Q: How long does the effect of a single dose of Alburel typically last?

The duration of the blood volume expansion effect can vary greatly depending on the patient’s initial condition and circulating blood volume. While the clinical effect may be short-term, the albumin protein itself has a biological half-life (the time it takes for half the drug to be eliminated) of approximately 15 to 20 days.


Q: What happens if I stop taking Alburel suddenly?

Official documents indicate that Alburel is a short-term, medically supervised infusion administered in a clinical setting, not a medicine taken at home. Therefore, the concept of a patient suddenly stopping treatment on their own does not apply. The infusion is stopped by the healthcare provider when the patient's acute circulatory status has stabilized or if a serious reaction occurs.


Q: Does Alburel cause weight gain or weight loss?

Alburel's primary function is to increase blood volume, which involves moving fluid into the blood vessels. This action can lead to fluid retention, a serious reaction known as hypervolemia (circulatory overload). Regulatory warnings indicate that signs of this condition can include sudden weight gain and swelling of the extremities.


Q: Is it common for Alburel to cause dizziness or drowsiness?

While dizziness is listed in regulatory documents, it is noted as a potential sign of circulatory overload, a serious and urgent adverse reaction. Drowsiness is not specifically listed as a common side effect of the medicine itself.


Q: Is there a link between Alburel and liver problems?

Regulatory information does not suggest that Alburel causes new liver problems. Instead, this product is studied and sometimes used in the clinical setting to manage certain acute complications that arise from existing liver conditions, such as liver cirrhosis.


Q: Is Alburel considered a controlled substance?

No, Human Albumin products like Alburel are not classified as controlled substances by government regulatory authorities. This classification is typically reserved for medicines with a potential for dependence or misuse.


Q: Can Alburel be used by children, and if so, what is the age limit?

Yes, official product information confirms that Alburel is used for pediatric patients. The dosing is carefully calculated based on the child's body weight, in alignment with established guidelines for use in children. A specific, strict minimum age limit is not typically outlined in the official product labeling.


Q: Is Alburel safe for older adults (seniors)?

Regulatory documents indicate that the standard approach for older adults (geriatric patients) remains the same: dosing is highly individualized based on the patient's specific circulatory need. Official information states there is no specific data available on the relationship of age to the effects of Human Albumin in this population.


Q: Can Alburel affect my ability to drive or operate machinery?

According to regulatory guidelines, the administration of Alburel is generally not expected to impair a patient's ability to drive or operate machinery. However, this is given the context of its use in a supervised clinical environment.


Q: Is there an equivalent generic version of Alburel available?

Alburel is a specific brand name for the substance known as Human Albumin. Because it is a plasma-derived product, there are multiple therapeutically equivalent Human Albumin products available from various manufacturers, though they may not be referred to as 'generic' in the traditional sense.


Q: Why do some people report feeling tired after starting Alburel?

Official regulatory documents indicate that unusual tiredness or weakness is not a common, mild side effect. This type of symptom is listed as a potential sign associated with severe adverse reactions, such as heart failure or serious allergic reactions, which are conditions where medical supervision is necessary.


Q: Is Alburel addictive or habit-forming?

No, regulatory classifications do not indicate that Alburel is either addictive or habit-forming. Its nature as a plasma volume expander means it does not affect the central nervous system in a way that leads to dependence.


Q: Does Alburel show up on standard drug tests?

As the active ingredient is Human Albumin, a naturally occurring protein in the body, it is generally not a substance that is tested for in standard workplace or forensic drug misuse screenings.


Q: Does Alburel have a Black Box Warning, and what does it mean?

Official product labeling indicates that Human Albumin products do not typically carry a Black Box Warning. This is the most severe warning issued by the FDA. Instead, the serious risks, such as circulatory overload and severe allergic reactions, are fully detailed in the Warnings and Precautions sections.


Q: Has Alburel been studied in specific patient populations, like those with kidney issues?

Yes, regulatory documents confirm that Alburel is used with caution in patients who have pre-existing kidney conditions. Official prescribing information sometimes notes its use for patients undergoing renal dialysis, and mentions conditions like anuria, where caution is required due to fluid status.


Q: Is Alburel intended to cure the condition or just manage symptoms?

Official indications for Alburel describe its purpose as the restoration and maintenance of blood volume. This function classifies it as a supportive therapy intended to manage acute, critical symptoms rather than providing a permanent cure for the underlying medical condition.


Q: What is the shelf life of Alburel, and what are the basic storage requirements?

The specific shelf life for the unopened product is defined on the manufacturer's product label and can vary (often several years). Regulatory requirements state it must be stored below a certain temperature, typically not exceeding 30 C (86 F), and must not be frozen to maintain product stability.


Q: Is Alburel available in different strengths or formulations?

Yes, the Human Albumin solutions are commercially supplied in different strengths, which are referred to as concentrations. These typically include 5%, 20%, and 25% solutions, allowing healthcare providers to choose the appropriate concentration for the patient's needs.

How should Alburel be stored and disposed of?

How to Store and Dispose of Alburel

Alburel (Human Albumin) must be stored according to strict regulatory conditions to maintain its stability, as it is a protein solution.


Official Storage Requirements

Condition Regulatory Rule
Temperature Store at a controlled temperature, typically not exceeding 30°C (86°F).
Prohibition Do not freeze the product.
Protection Store in the original container to protect the solution from light.
Safety Keep out of the sight and reach of children.
Stability Do not use the solution if it appears cloudy, turbid, or has visible particles.

Handling and Disposal

Once the container is opened, the solution must be used immediately, with the infusion completed within four hours due to the absence of preservatives. Any unused product remaining after this period must be discarded. Expired or unused medicine must be disposed of in accordance with local pharmaceutical waste regulations; do not dispose of via household waste or wastewater.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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