Product image of Haemate P (Human Coagulation Factor Viii, Human Von Willebrand Factor) supplied by GNH India

Haemate P

Active Ingredient:
Human Coagulation Factor Viii, Human Von Willebrand Factor
Origin:
EU

Haemate P (Human Coagulation Factor Viii, Human Von Willebrand Factor)

Haemate P is a sterile solution containing human coagulation factor VIII and human von Willebrand factor, used as a coagulation factor replacement therapy. It is supplied without a specified strength or dosage form in the European market and is indicated for patients with hemophilia A and von Willebrand disease. The product provides exogenous clotting proteins to support normal hemostasis.

Manufacturer / TM Owner

Csl Behring Gmbh

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Indications & Clinical Uses

Haemate P is indicated for the management of bleeding episodes and perioperative prophylaxis in individuals with inherited deficiencies of factor VIII and von Willebrand factor. It is used in clinical practice to restore clotting activity and reduce bleeding risk.

  • Treatment of acute bleeding episodes in hemophilia A patients.
  • Surgical and invasive procedure prophylaxis for hemophilia A.
  • Management of bleeding in von Willebrand disease types 1, 2, and 3.
  • Long‑term prophylaxis to prevent recurrent hemorrhage in severe hemophilia A.
  • Supportive therapy during childbirth for women with von Willebrand disease.
  • Adjunctive use when other factor concentrates are unavailable.

Side Effects

Adverse reactions to Haemate P may vary in frequency and severity. Common side effects are generally mild, while serious events are less frequent but require medical attention.

Common

  • Headache
  • Fever or chills
  • Nausea or vomiting
  • Injection site erythema or swelling
  • Mild arthralgia
  • Transient increase in blood pressure

Serious

  • Development of inhibitors (antibodies) against factor VIII or von Willebrand factor
  • Anaphylactic or severe allergic reactions
  • Thromboembolic events (e.g., deep vein thrombosis)
  • Hemolytic reactions
  • Severe hypertension or hypertensive crisis
  • Renal impairment associated with infusion.

Precautions & Warnings

Healthcare professionals should assess patient history and monitor for potential risks when using Haemate P. Specific considerations include:

  • Screen for pre‑existing inhibitors to factor VIII or von Willebrand factor before initiating therapy.
  • Monitor for signs of allergic reactions, especially during the first infusion.
  • Use caution in patients with a history of thrombosis or cardiovascular disease.
  • Adjust dosing in patients with renal or hepatic impairment as clinically indicated.
  • Avoid use in individuals with known hypersensitivity to any component of the product.
  • Ensure proper storage conditions to maintain product stability.
  • Educate patients on recognizing symptoms of inhibitor development.

Avoid Interactions

Haemate P may interact with other medications or substances that affect hemostasis or immune response. Consider the following when co‑administering:

Avoid

  • Concurrent use of pro‑coagulant agents (e.g., activated prothrombin complex concentrates) without specialist guidance.
  • Administration with high‑dose aspirin or other non‑steroidal anti‑inflammatory drugs that increase bleeding risk.

Use with caution

  • Immunosuppressive therapies that may alter inhibitor development.
  • Antifibrinolytic agents (e.g., tranexamic acid) – monitor for thrombotic complications.
  • Other plasma‑derived products – assess cumulative factor levels.
  • Vaccinations administered shortly before or after infusion – observe for enhanced immune response.
  • Herbal supplements affecting platelet function (e.g., ginkgo, garlic).

Frequently Asked Questions

Haemate P supplies exogenous factor VIII to replace the deficient clotting protein in patients with hemophilia A, helping to control bleeding and prevent hemorrhagic episodes.

Yes, Haemate P is commonly administered before surgical or invasive procedures to ensure adequate clotting factor levels and reduce intra‑operative bleeding risk.

Haemate P contains von Willebrand factor and is indicated for types 1, 2, and 3 von Willebrand disease, providing the missing protein to improve platelet adhesion and clot formation.

Haemate P is a plasma‑derived concentrate containing both factor VIII and von Willebrand factor, whereas recombinant products are synthetically produced and typically contain only factor VIII.

Patients should have regular assessments of factor activity levels, inhibitor screening, and clinical observation for signs of allergic reactions or thrombotic events.

Haemate P should be stored according to the manufacturer’s instructions, usually refrigerated between 2 °C and 8 °C, and protected from light to maintain stability.

Haemate P is formulated for intravenous infusion; subcutaneous administration is not recommended without specific clinical guidance.

Inhibitor development may present as reduced efficacy of the product, unexpected bleeding despite treatment, or laboratory detection of antibodies against factor VIII or von Willebrand factor.

Prophylactic infusions of Haemate P are often employed in severe hemophilia A to maintain trough factor levels and prevent spontaneous joint bleeds.

The patient should stop the infusion immediately, seek emergency medical care, and inform their healthcare provider about the reaction for future management.

Concurrent use with anticoagulants may increase bleeding risk; clinicians should evaluate the necessity and adjust dosing or monitoring accordingly.

Haemate P is approved for use in children with hemophilia A or von Willebrand disease, with dosing individualized based on weight and clinical response.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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