Symptoms

The symptoms of hereditary factor X deficiency can range from mild to severe.

Symptoms of mild factor X deficiency may include1:

  • Umbilical bleeding
  • Easy bruising
  • Nosebleeds
  • Mouth bleeds
  • Bleeding longer than normal after injury or surgery

Symptoms of severe factor X deficiency may include1:

  • Joint bleeds and bruising
  • Spontaneous bleeding in the head, spinal cord, or gastrointestinal tract (for example: stomach or intestines)

Women with factor X deficiency may experience1:

  • Heavy or prolonged bleeding during menstruation (periods)
  • Complications during pregnancy or childbirth

A study of people with hereditary factor X deficiency reported many different types of bleeds2

Frequency of bleeding by type of bleed

*Among women of reproductive age.

References: 1. Brown DL, Kouides PA. Diagnosis and treatment of inherited factor X deficiency. Haemophilia. 2008;14(6):1176-82. 2. Herrmann FH, Auerswald G, Ruiz-Saez A, et al. Factor X deficiency: clinical manifestations of 102 subjects from Europe and Latin America with mutations in the factor 10 gene. Haemophilia. 2006;12:479-489.

Indications for COAGADEX

COAGADEX, a plasma-derived blood coagulation factor X concentrate, is indicated in adults and children (aged 12 years and above) with hereditary factor X deficiency for:

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

Important Safety Information for COAGADEX

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

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

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 ≥5% of subjects) with COAGADEX were infusion site erythema, infusion site pain, fatigue and back pain.

Please see complete Prescribing Information for COAGADEX.