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

Patients with hereditary factor X deficiency may experience many different types of bleeds, including potentially life-threatening intracranial bleeds2

  • In an analysis of 102 subjects with hereditary factor X deficiency, 42 presented with clinical bleeding symptoms

Types of Bleeds in Subjects with Hereditary Factor X Deficiency2

Frequency of bleeding by type of bleed

*Women of reproductive age (n=17).

References: 1. Brown DL, Kouides PA. Haemophilia. 2008;14(6):1176-1182. 2. Herrmann FH, Auerswald G, Ruiz-Saez A, et al. Haemophilia. 2006;12:479-489.

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.