About Hereditary Factor X Deficiency

Factor X deficiency is a rare bleeding disorder. It is caused by having too little of a protein called factor X in the blood.1

  • Factor X plays an important role in blood clotting (coagulation)
  • People with factor X deficiency have a higher risk of excess bleeding

Factor X deficiency is often caused by a defect in the factor X gene that is passed down from parents to children.

  • Hereditary factor X deficiency is an autosomal recessive disorder (meaning that a person must receive a defective factor X gene from both parents to have the condition)
  • It affects approximately 1:1,000,000 people in the general population
  • The condition occurs in males and females at an equal rate

A Closer Look at Factor X Deficiency

Reference: 1. Brown DL, Kouides PA. Haemophilia. 2008;14(6):1176-1182.

Indications and Usage for COAGADEX

COAGADEX, a plasma-derived blood coagulation factor X concentrate, is indicated in adults and children with hereditary factor X deficiency for:

Limitation of Use

Perioperative management of bleeding in major surgery in patients with severe hereditary factor X deficiency has not been studied.

Contraindication for COAGADEX

COAGADEX is contraindicated in patients with known hypersensitivity to any of the components of the product.

Important Safety Information for COAGADEX

Allergic type hypersensitivity reactions, including anaphylaxis, are possible with COAGADEX. If symptoms occur, patients should discontinue use of the product immediately, contact their physician, and administer appropriate treatment.

The formation of neutralizing antibodies (inhibitors) to factor X is a possible complication in the management of individuals with factor X deficiency. Carefully monitor patients taking COAGADEX for the development of inhibitors by appropriate clinical observations and laboratory tests.

COAGADEX is made from human plasma and may contain infectious agents, e.g. viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases, vCJD or CJD, have been associated with the use of COAGADEX.

In clinical studies, the most common adverse reactions (frequency ‚Č•5% of subjects) with COAGADEX were infusion site erythema, infusion site pain, fatigue and back pain.

Please see complete Prescribing Information for COAGADEX.