Factor 10 Brand Name– Coagadex
What is Factor 10
Factor 10 is a human plasma-derived coagulation factor indicated for the control and prevention of bleeding in patients with hereditary factor X deficiency, including perioperative management of patients with mild and moderate factor X deficiency.
During a multicenter non-randomized trial, factor X effectively controlled 98% of bleeding episodes (spontaneous, traumatic, and menorrhagic) in 16 patients (208 bleeding episodes; 6 pediatric patients 12 to 17 years) with moderate to severe hereditary factor X deficiency.
Factor 10 also controlled blood loss before and after surgery in 5 individuals (age range: 14 to 59 years) with mild (n = 2), moderate (n = 1), and severe (n = 2) deficiency who underwent 7 surgical procedures.
Of note, no patients with severe deficiency received factor X for perioperative management of major surgery during clinical trials. No minor or major bleeds, or a lower frequency of bleeds than expected, were reported in 9 children (age range: 2.6 to 11.9 years) receiving factor X for routine bleeding prophylaxis during a 6 month period. No safety concerns were identified in any study.
Hereditary factor X deficiency, which causes blood not to clot properly, is rare, affecting an estimated 1 in 500,000 to 1,000,000 individuals worldwide. Until the orphan drug approval of Factor 10, no specific coagulation factor replacement was available for patients with hereditary factor X deficiency; patients were primarily managed with fresh-frozen plasma or plasma-derived prothrombin complex concentrates.
Factor 10 availability increases treatment options for patients with this rare bleeding disorder.
Indications
- bleeding prophylaxis
- hemorrhage
- hereditary factor X deficiency
- surgical bleeding
For the on-demand treatment and control of hemorrhage in patients with hereditary factor X deficiency
Side Effects
- anaphylactoid reactions
- antibody formation
- back pain
- erythema
- fatigue
- infusion-related reactions
Monitoring Parameters
- clotting inhibitor titers
- factor X concentrations
Contraindications
- breast-feeding
- factor X inhibitors
- geriatric
- infection
- pregnancy
Interactions
- Apixaban
- Betrixaban
- Edoxaban
- Fondaparinux
- Protein C Concentrate, Human
- Prothrombin Complex Concentrate, Human
- Rivaroxaban
