Coagadex: first treatment for hereditary Factor X deficiency

Coagadex has been approved for use as the first product specifically designed to treat the rare bleeding disorder, hereditary Factor X deficiency.

Individuals with Factor X deficiency experience excessive bleeding or bruising from relatively minor trauma. | SCIENCE PHOTO LIBRARY
Individuals with Factor X deficiency experience excessive bleeding or bruising from relatively minor trauma. | SCIENCE PHOTO LIBRARY

Coagadex is a plasma-derived preparation of human Factor X and is indicated to prevent and treat acute bleeding episodes, and for perioperative management of bleeds, in patients with hereditary Factor X deficiency.

Hereditary Factor X deficiency is an autosomal recessive disorder that is estimated to affect between 1 in 500,000 and 1 in 1,000,000 of the population.

Further information
View Coagadex drug record
Summary of Product Characteristics
Manufacturer: BPL

Factor X is usually activated either by Factor IXa (via the intrinsic coagulation pathway) or Factor VIIa (via the extrinsic pathway), to produce Factor Xa. Factor Xa then converts prothrombin to thrombin, which in turn converts fibrinogen to fibrin. Individuals with Factor X deficiency bruise and bleed easily because they are unable to complete this coagulation cascade properly.

Administration and dosage

Coagadex is given intravenously, and treatment should be supervised by a physician experienced in treating rare bleeding disorders. Patients can be taught to self-medicate, although this requires regular reviews.

The dosage depends on the severity of Factor X deficiency, the location and extent of bleeding, and the patient’s clinical condition. There is no anticipated need to vary the dose based on renal or hepatic function.

Clinical evidence

Plasma-derived Factor X was assessed in an open-label, non-randomised trial in 16 patients aged 12 years and above with moderate to severe hereditary Factor X deficiency. 

A total of 187 bleeding episodes (spontaneous, traumatic or menorrhagic) was analysed, and the efficacy of plasma-derived Factor X was rated as 'good' or 'excellent' in 98% of these. In the two patients who used plasma-derived Factor X for routine prophylaxis, no bleeds occurred.

The product was also evaluated in five patients with mild to severe hereditary Factor X deficiency undergoing surgery. In a total of seven surgical procedures analysed, there was no post-operative bleeding and no requirement for blood transfusions.

Common adverse effects of plasma-derived Factor X include back pain, infusion site erythema, fatigue and infusion site pain. 

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