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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 solution for injection containing human serum albumin as the active ingredient. It is supplied in an unspecified strength and is marketed in the European Union as a prescription‑only plasma protein product. The formulation is intended for intravenous administration to increase plasma oncotic pressure and support intravascular volume in clinical situations requiring volume expansion, and may be used under physician supervision in acute care settings.

Manufacturer / TM Owner

Takeda Gmbh

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Indications & Clinical Uses

Human Albumin Baxalta is employed in clinical practice primarily as a plasma volume expander and to correct low serum albumin levels.

  • Treatment of hypovolemia secondary to burns, trauma, or surgery.
  • Management of hypoalbuminemia in patients with liver disease, nephrotic syndrome, or malnutrition.
  • Support of circulatory volume in septic shock or severe sepsis when fluid resuscitation is needed.
  • Adjunct therapy during cardiopulmonary bypass or extracorporeal membrane oxygenation (ECMO).
  • Replacement therapy in patients with massive plasma loss during plasmapheresis.

How It Works

  • Human Albumin Baxalta works by increasing the oncotic pressure within the plasma compartment. The infused human serum albumin binds water molecules, drawing fluid from the interstitial space into the vascular lumen, thereby expanding intravascular volume. This effect helps maintain hemodynamic stability and supports tissue perfusion in conditions where plasma volume is depleted or albumin concentrations are low.

Side Effects

Adverse reactions to Human Albumin Baxalta can vary in frequency and severity.

Common

  • Fever or chills
  • Transient hypotension or hypertension
  • Rash or urticaria
  • Headache
  • Nausea or vomiting
  • Mild edema at infusion site

Serious

  • Anaphylactic or severe allergic reactions
  • Volume overload leading to pulmonary edema
  • Hemolysis
  • Thromboembolic events such as deep vein thrombosis
  • Acute kidney injury
  • Severe hypotension requiring intervention

Precautions & Warnings

Before administering Human Albumin Baxalta, clinicians should evaluate patient-specific factors and monitor for potential complications.

  • Assess volume status and cardiac function prior to infusion.
  • Monitor vital signs, fluid balance, and serum electrolytes during and after administration.
  • Use caution in patients with heart failure, renal insufficiency, or pulmonary disease.
  • Avoid rapid infusion rates to reduce the risk of hypotension or circulatory stress.
  • Screen for known hypersensitivity to human albumin or other plasma-derived products.
  • Consider the theoretical risk of infectious agent transmission despite donor screening.

Avoid Interactions

Human Albumin Baxalta may interact with other medications or therapies that affect fluid balance or immune responses.

Avoid

  • Concurrent use of additional volume expanders that could precipitate fluid overload.
  • Simultaneous administration of agents known to increase the risk of anaphylaxis, such as certain antibiotics.

Use with caution

  • Diuretics, because combined effects may alter intravascular volume.
  • Anticoagulants, as changes in plasma volume can influence coagulation parameters.
  • Vasodilators or other antihypertensive drugs, which may exacerbate blood pressure fluctuations during infusion.

Frequently Asked Questions

Human Albumin Baxalta is a sterile intravenous solution that contains human serum albumin, a plasma protein used to increase oncotic pressure and expand intravascular volume.

It is commonly used to treat hypovolemia, correct hypoalbuminemia, support patients with severe burns, trauma, surgery, sepsis, or during procedures like cardiopulmonary bypass and ECMO.

The albumin molecules bind water, raising plasma oncotic pressure, which draws fluid from the interstitial space into the bloodstream, thereby expanding circulating volume.

Use with caution; clinicians should assess cardiac function and monitor for signs of fluid overload because increased intravascular volume can exacerbate heart failure.

Common reactions include fever, chills, mild hypotension or hypertension, rash, headache, nausea, and mild edema at the infusion site.

Serious events may include anaphylaxis, severe hypotension, pulmonary edema, hemolysis, thromboembolic complications, and acute kidney injury.

There are no absolute contraindications listed, but it should be avoided in patients with known hypersensitivity to human albumin or other plasma-derived products.

Vital signs, fluid balance, serum electrolytes, and signs of allergic reaction should be monitored throughout the infusion and for a period afterward.

Concurrent use with other volume expanders should be avoided to reduce the risk of fluid overload unless specifically directed by a physician.

The product should be stored according to the manufacturer’s instructions, typically refrigerated, and protected from light until it is prepared for intravenous administration.

The pregnancy safety category is not established; it should be used only if the potential benefit justifies the potential risk to the fetus, under medical supervision.

Yes, volume expansion can affect coagulation parameters, so anticoagulants should be used with caution and patients should be closely monitored.

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GNH India Pharmaceuticals Limited

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Last updated:

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