GNH USA

Europe — EMA

Haemate

Haemate is an EU‑approved IV therapy containing human factor VIII and von Willebrand factor for hemophilia A and von Willebrand disease treatment.

Human Coagulation Factor Viii, Human Von Willebrand Factor

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What is Human Coagulation Factor Viii, Human Von Willebrand Factor?

Haemate is a prescription intravenous medication containing human coagulation factor VIII and human von Willebrand factor. It is supplied as a sterile solution for intravenous infusion; specific strength and dosage form are not disclosed in the summary. The product is marketed in the European Union and is used to replace deficient clotting factors in patients with hemophilia A or von Willebrand disease through therapy management protocol.

What is Human Coagulation Factor Viii, Human Von Willebrand Factor used for?

Haemate is indicated for several clinical situations involving deficiencies of factor VIII and von Willebrand factor.

- Treatment of bleeding episodes in patients with hemophilia A. - Management of all types of von Willebrand disease, including type 1, 2, and 3. - Prophylactic therapy before surgical or invasive procedures in individuals with combined factor VIII and von Willebrand factor deficiency. - Long‑term prophylaxis to reduce the frequency of spontaneous bleeds in severe hemophilia A. - Replacement therapy in patients with combined factor VIII and von Willebrand factor deficiency when on‑demand treatment is required.

What are the side effects of Human Coagulation Factor Viii, Human Von Willebrand Factor?

Adverse reactions to Haemate have been reported; they vary in frequency and severity.

Common: - Headache - Fever or chills - Nausea or vomiting - Injection site reactions such as redness or swelling

Serious: - Development of inhibitors (antibodies) against factor VIII or von Willebrand factor - Allergic reactions including rash, urticaria, or anaphylaxis - Thromboembolic events such as deep‑vein thrombosis - Renal or hepatic dysfunction in rare cases

What precautions apply to Human Coagulation Factor Viii, Human Von Willebrand Factor?

Before initiating Haemate, clinicians should evaluate several safety considerations to minimize risk.

- Assess for a history of inhibitors to factor VIII or von Willebrand factor. - Verify patient’s baseline liver and kidney function tests. - Use caution in patients with a known hypersensitivity to plasma‑derived products. - Monitor for signs of thrombosis, especially in individuals with cardiovascular risk factors. - Consider pregnancy status; safety data are limited. - Review concurrent anticoagulant or antiplatelet therapy. - Ensure proper storage and handling to maintain product integrity.

What does Human Coagulation Factor Viii, Human Von Willebrand Factor interact with?

Haemate may interact with other medicines; some combinations should be avoided while others require careful monitoring.

Avoid: - Concomitant use of other plasma‑derived clotting factor concentrates without medical supervision. - Simultaneous administration of high‑dose pro‑coagulant agents that could increase thrombosis risk.

Use with caution: - Antifibrinolytic agents such as tranexamic acid; monitor for excessive clot formation. - Anticoagulants (e.g., warfarin, direct oral anticoagulants); adjust dosing and monitor coagulation parameters. - Immunosuppressive drugs that may affect inhibitor development. - Vaccines administered intramuscularly; observe for local reactions.

Frequently asked questions

What is the mechanism of action of Haemate in hemophilia A?+
Haemate supplies exogenous human factor VIII and von Willebrand factor, restoring the intrinsic coagulation pathway and enhancing platelet adhesion, which helps form stable clots in patients lacking these proteins.
How is Haemate administered to patients?+
Haemate is given by intravenous infusion under medical supervision, typically in a clinical setting or at home after appropriate training.
Can Haemate be used for surgical prophylaxis in von Willebrand disease?+
Yes, Haemate is indicated for prophylactic use before surgical or invasive procedures to reduce bleeding risk in patients with von Willebrand disease.
What monitoring is required after starting Haemate therapy?+
Clinicians usually monitor clotting assays, inhibitor development, liver and kidney function, and watch for signs of allergic reactions or thrombosis.
Is Haemate safe for use during pregnancy?+
Safety data for Haemate in pregnancy are limited; the product should be used only if the potential benefit justifies the potential risk to the fetus.
What are the common side effects of Haemate?+
Common adverse effects include headache, fever or chills, nausea or vomiting, and mild injection‑site reactions such as redness or swelling.
What serious adverse reactions can occur with Haemate?+
Serious reactions may include development of inhibitors against factor VIII or von Willebrand factor, severe allergic responses including anaphylaxis, thromboembolic events, and rare renal or hepatic dysfunction.
Should Haemate be avoided with other clotting factor concentrates?+
Concurrent use of other plasma‑derived clotting factor concentrates without medical guidance is generally avoided to prevent dosing errors and increased thrombosis risk.
How does Haemate interact with antifibrinolytic agents?+
When used together with antifibrinolytics such as tranexamic acid, patients should be monitored for excessive clot formation, as the combination can enhance hemostasis.
What is the ATC classification for Haemate?+
Haemate is classified under ATC code B02BD, which designates blood‑and‑blood‑forming‑organ‑substances, specifically hemostatics.
Is Haemate a prescription‑only medication?+
Yes, Haemate is available only with a prescription and must be administered under the direction of a qualified healthcare professional.
What should patients do if they experience an allergic reaction to Haemate?+
Patients should stop the infusion immediately, seek emergency medical attention, and inform their healthcare provider about the reaction for further evaluation.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Human Coagulation Factor Viii, Human Von Willebrand Factor
Route
Intravenous Use
Manufacturer
Csl Behring Gmbh
Origin
EU

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