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

Haemate

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

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

Haemate is a prescription injectable solution that contains human coagulation factor VIII and von Willebrand factor to replace deficient clotting proteins in patients with hemophilia A and von Willebrand disease. Administered intravenously, it is manufactured in the European Union and supplied in a sterile vial for single‑use infusion. The formulation aims to rapidly restore the intrinsic coagulation pathway and support hemostasis during bleeding episodes or before surgery.

Manufacturer / TM Owner

Csl Behring Gmbh

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Indications & Clinical Uses

Haemate is indicated for the management of bleeding disorders related to factor VIII and von Willebrand factor deficiencies.

  • Treatment of acute bleeding episodes in patients with hemophilia A (factor VIII deficiency).
  • Prophylactic replacement therapy to prevent spontaneous or trauma‑induced bleeds in hemophilia A.
  • Management of bleeding and surgical prophylaxis in patients with von Willebrand disease, particularly type 3.
  • Support during major surgery or invasive procedures in individuals with combined factor VIII/vWF deficiency.
  • Adjunct therapy in patients undergoing dental extractions or minor procedures when hemostasis is required.

Side Effects

The safety profile of Haemate includes both frequently observed reactions and rare but serious events.

Common

  • Mild infusion‑site reactions such as erythema, swelling, or pain.
  • Transient fever or chills during or shortly after administration.
  • Headache or fatigue.

Serious

  • Allergic anaphylactic reactions, including urticaria, bronchospasm, or hypotension.
  • Development of inhibitors (antibodies) against factor VIII or von Willebrand factor.
  • Thromboembolic events such as deep‑vein thrombosis or pulmonary embolism.

Precautions & Warnings

Clinicians should consider several precautions when prescribing Haemate to ensure safe and effective use.

  • Assess baseline factor VIII and von Willebrand activity levels before initiating therapy.
  • Monitor for the development of inhibitors, especially in previously untreated patients.
  • Use caution in patients with a history of allergic reactions to plasma‑derived products.
  • Avoid rapid infusion rates; administer according to recommended infusion guidelines to reduce adverse reactions.
  • Evaluate cardiovascular risk, as rapid correction of coagulation may increase thrombosis risk.
  • Pregnancy and lactation status should be reviewed, as safety data are limited.
  • Renal or hepatic impairment may affect clearance; adjust dosing as clinically indicated.

Avoid Interactions

Haemate may interact with other medications that affect hemostasis or immune response.

Avoid

  • Concurrent use of other pro‑coagulant agents (e.g., activated factor VII) without specialist guidance.
  • Administration with investigational gene‑therapy products targeting factor VIII.

Use with caution

  • Antifibrinolytic agents such as tranexamic acid may augment hemostatic effect; monitor for thrombosis.
  • Immunosuppressive drugs (e.g., rituximab) may alter inhibitor development risk.
  • Concomitant use of high‑dose steroids may mask allergic reactions.
  • Vaccines administered shortly after infusion may have reduced efficacy; schedule appropriately.

Frequently Asked Questions

Haemate contains human coagulation factor VIII and human von Willebrand factor as its active ingredients.

Haemate is supplied as an injectable solution and is administered intravenously under medical supervision.

Haemate is prescribed for hemophilia A, von Willebrand disease (especially type 3), and for surgical or traumatic bleeding prophylaxis in patients with factor VIII/vWF deficiency.

Yes, Haemate can be used as prophylactic replacement therapy to prevent spontaneous or trauma‑induced bleeds in hemophilia A patients.

Common side effects include mild infusion‑site reactions, transient fever or chills, headache, and fatigue.

Serious reactions may include anaphylaxis, development of inhibitors against factor VIII or von Willebrand factor, and thromboembolic events such as deep‑vein thrombosis.

Baseline screening for factor VIII and von Willebrand activity, as well as monitoring for inhibitor development, is recommended before and during treatment.

Concurrent use of other pro‑coagulant agents and investigational gene‑therapy products targeting factor VIII should be avoided without specialist guidance.

Antifibrinolytic agents such as tranexamic acid can be used with caution, but patients should be monitored for signs of thrombosis.

Patients with cardiovascular risk should be evaluated before therapy, as rapid correction of coagulation may increase the risk of thrombotic events.

Safety data for Haemate in pregnancy and lactation are limited; the benefits and risks should be carefully considered by the prescribing clinician.

Haemate should be stored according to the manufacturer’s instructions, typically refrigerated and protected from light, and used before the expiration date.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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