Europe — EMA
Human Albumin Baxalta (Human Serum Albumin)
Human Albumin Baxalta is an EU‑approved intravenous human serum albumin used as a plasma volume expander for hypovolemia, shock, burns, and hypoalbuminemia.
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What is 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.
What is Human Serum Albumin used for?
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.
What are the side effects of Human Serum Albumin?
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.
What precautions apply to Human Serum Albumin?
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.
What does Human Serum Albumin interact with?
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.



