COAGADEX is a High-Purity Factor X Product

COAGADEX has low levels of proteins other than factor X

Composition of COAGADEX: % of total protein

Pre-ATI/IATI, pre-alpha-trypsin inhibitor/inter-alpha-trypsin inhibitor.

  • Laboratory tests for potential thrombogenicity did not detect factor Xa or factor IIa

COAGADEX is the first and only product that is manufactured based on a factor X assay2

Selected Factor X-Containing Products
  • Factor X content in Prothrombin Complex Concentrates (PCCs) is an estimate based on historical measurements and a factor X assay level is not listed on each vial
  • PCCs are manufactured based on a factor IX assay, and the amount of factor II, VII, and X in a vial can vary considerably between products and between lots of the same product
  • Elevated levels of factors II, VII, and IX may be associated with an increased risk of thromboembolic complications4

References: 1. Data on file, BPL-RD050-0515. 2. COAGADEX® (Coagulation Factor X, Human) Prescribing Information. Durham, NC: BPL Limited. 2015. 3. Brown DL, Kouides PA. Diagnosis and treatment of inherited factor X deficiency. Haemophilia. 2008;14(6):1176-82. 4. Menegatti M, Peyvandi F. Factor X deficiency. Semin Thromb Hemost. 2009;35:407-415.

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

Please see complete Prescribing Information for COAGADEX.