Europe — EMA
Octaplaslg (Human Plasma Protein)
GNH USA supplies Octaplaslg (Human plasma protein fraction), a plasma protein fraction for replacement therapy in coagulation factor deficiencies and volume
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What is Human Plasma Protein?
Human plasma protein fraction, the active ingredient in Octaplaslg, is a plasma protein fraction presented as a lyophilized powder for intravenous use. It provides replacement therapy for patients with multiple coagulation factor deficiencies and supports intravascular volume in hypovolemia or massive transfusion. Octaplaslg is sourced from EU plasma collections and is indicated for hemostatic support and volume expansion.
GNH USA supplies Octaplaslg as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres and clinics worldwide.
What is Human Plasma Protein used for?
Octaplaslg, a plasma protein fraction, is used to address disorders of coagulation and intravascular volume loss. - Multiple coagulation factor deficiencies: replaces deficient clotting factors to improve hemostasis. - Hypovolemia or massive transfusion: expands intravascular volume to maintain circulatory stability. - Liver disease or major surgery: supplies plasma proteins to support coagulation and oncotic pressure.
What are the side effects of Human Plasma Protein?
Adverse reactions may occur following intravenous infusion of Octaplaslg.
Common Side Effects: - Fever or chills: mild temperature elevation during or after infusion. - Allergic rash or urticaria: skin redness or hives. - Mild hypotension: transient drop in blood pressure. - Headache: transient cranial discomfort. - Nausea: mild gastrointestinal upset. - Transient tachycardia: brief increase in heart rate.
Serious or Rare Side Effects: - Anaphylaxis: severe allergic reaction requiring immediate intervention. - Transfusion‑related acute lung injury (TRALI): acute respiratory distress post‑infusion. - Severe hypotension or shock: marked circulatory collapse. - Hemolysis: destruction of red blood cells. - Viral transmission risk: rare infection from plasma donors. - Disseminated intravascular coagulation (DIC): uncontrolled clotting and bleeding.
What precautions apply to Human Plasma Protein?
Before administering Octaplaslg, clinicians should consider several safety measures. - Assess coagulation status: verify baseline clotting parameters and factor levels. - Monitor for allergic reactions: observe patient during and after infusion for signs of hypersensitivity. - Use compatible plasma: ensure donor plasma matches recipient ABO/Rh when possible. - Avoid in IgA‑deficient patients: risk of severe anaphylaxis. - Observe for volume overload: especially in patients with cardiac or renal impairment. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.
What does Human Plasma Protein interact with?
Octaplaslg may interact with other therapies that affect coagulation or fluid balance.
Major Interactions (Avoid): - High‑dose anticoagulants (e.g., heparin, warfarin): may diminish hemostatic benefit. - Immunoglobulin therapy: increased risk of allergic or anaphylactic reactions. - Live vaccines: potential alteration of immune response.
Moderate Interactions (Monitor Closely): - Diuretics: risk of volume depletion or overload. - ACE inhibitors or ARBs: possible blood pressure fluctuations. - Corticosteroids: may modify immune response and infection risk. - Other plasma‑derived products: cumulative protein load may affect oncotic pressure.



