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Human Albumin Baxalta

Active Ingredient:
Human Serum Albumin
Origin:
EU

Human Albumin Baxalta (Human Serum Albumin)

Human Albumin Baxalta is a sterile intravenous solution containing human serum albumin as the active ingredient. It is supplied in a standard concentration used for plasma volume expansion, and is marketed in the European Union as a prescription‑only product. The preparation is derived from pooled human plasma and is indicated for conditions that require rapid restoration of circulating oncotic pressure. It is administered by healthcare professionals in hospital or clinic settings.

Manufacturer / TM Owner

Baxalta Innovations Gmbh

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Indications & Clinical Uses

Human Albumin Baxalta is employed as a volume expander in clinical situations where plasma oncotic pressure is reduced.

  • Management of hypovolemia associated with acute blood loss or dehydration.
  • Treatment of circulatory shock when rapid plasma volume restoration is needed.
  • Supportive care for severe burn patients to replace lost plasma proteins.
  • Correction of hypoalbuminemia in chronic liver disease or nephrotic syndrome.

How It Works

  • Human Albumin Baxalta works by increasing the concentration of albumin in the intravascular compartment. Albumin contributes the majority of plasma oncotic pressure; raising its level draws water from the interstitial space into the vasculature, expanding circulating blood volume. The added protein also serves as a carrier for endogenous substances such as hormones, fatty acids, and drugs, supporting physiological transport and distribution.

Side Effects

Adverse reactions to Human Albumin Baxalta are generally related to the infusion process or to immunologic responses to the plasma protein.

Common

  • Mild fever or chills during infusion.
  • Headache or dizziness.
  • Nausea or vomiting.
  • Transient hypertension or hypotension.
  • Localized erythema or swelling at the infusion site.

Serious

  • Anaphylactic or severe allergic reaction (e.g., urticaria, bronchospasm).
  • Acute hemolysis or renal dysfunction.
  • Volume overload leading to pulmonary edema.
  • Transmission of infectious agents (theoretical risk).
  • Thromboembolic events.

Precautions & Warnings

Before using Human Albumin Baxalta, clinicians should evaluate patient history and monitor specific clinical parameters.

  • Assess for known hypersensitivity to human albumin or plasma derivatives.
  • Evaluate fluid status; avoid use in patients with uncontrolled congestive heart failure.
  • Monitor blood pressure and central venous pressure during and after infusion.
  • Use caution in patients with renal impairment or liver disease due to altered albumin metabolism.
  • Verify that the product is within its expiration date and has been stored according to label instructions.
  • Consider the risk of volume overload in pediatric or elderly patients.

Avoid Interactions

Human Albumin Baxalta may affect the pharmacokinetics of co‑administered drugs and can interact with certain clinical conditions.

Avoid

  • Concurrent administration of high‑dose diuretics that may exacerbate intravascular volume shifts.
  • Use with other plasma expanders (e.g., hydroxyethyl starch) without clear clinical justification.
  • Simultaneous infusion of blood products that could increase the risk of transfusion reactions.

Use with caution

  • Vasopressor agents, as rapid volume expansion may alter required dosing.
  • Anticoagulants, because changes in plasma protein binding can affect anticoagulant activity.
  • Drugs with narrow therapeutic windows that are highly protein‑bound (e.g., phenytoin, warfarin).
  • Immunosuppressive therapies, due to potential additive effects on immune response.

Frequently Asked Questions

Human Albumin Baxalta is used as a plasma volume expander to restore oncotic pressure and increase circulating blood volume in patients with hypovolemia, shock, severe burns, or hypoalbuminemia.

The product is supplied as a sterile solution for intravenous infusion and must be administered by a qualified healthcare professional in a controlled clinical setting.

Use in children should be based on careful clinical judgment, considering the risk of volume overload and the specific indication; dosing and monitoring differ from adult practice.

Common allergic manifestations include mild fever, chills, rash, itching, or localized swelling at the infusion site. Any signs of severe hypersensitivity require immediate medical attention.

The product is derived from pooled human plasma and undergoes rigorous viral inactivation and purification processes, making the risk of infectious disease transmission extremely low, though not zero.

Vital signs such as blood pressure, heart rate, and central venous pressure should be monitored before, during, and after the infusion to detect volume shifts or adverse reactions.

High‑dose diuretics may exacerbate fluid shifts; clinicians often adjust diuretic therapy based on the patient’s volume status and the intended therapeutic effect of the albumin infusion.

Albumin is a major carrier protein; increasing its concentration can alter the free fraction of highly protein‑bound drugs, potentially modifying their efficacy or toxicity.

It may be used to correct hypoalbuminemia associated with chronic liver disease when rapid restoration of oncotic pressure is clinically indicated.

The solution should be stored according to the manufacturer’s label, typically refrigerated, and protected from light to maintain stability until the expiration date.

Simultaneous infusion with blood products can increase the risk of transfusion reactions; they should be administered separately unless clinically justified.

Human Albumin Baxalta is classified under ATC code B05AA02, which corresponds to plasma protein solutions used as volume expanders.

Published by

GNH India Pharmaceuticals Limited

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Last updated:

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