COAGADEX Is a High-Purity Factor X Product

COAGADEX is the first and only high-purity factor X product available in the U.S.

Composition of COAGADEX: % of total protein1

94% of the protein in COAGADEX is factor X
COAGADEX* is the only treatment recommended by the National Hemophilia Foundation’s Medical and Scientific Advisory Council (MASAC) for hereditary factor X deficiency6

*Plasma-derived factor X concentrate. COAGADEX is the only FDA-licensed, plasma-derived factor X concentrate.

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

Selected Factor X-Containing Products
*IU of factor II, VII, and IX per 100 IU of factor X
IU of factor II, VII, and X per IU of factor IX
  • Elevated levels of factors II, VII, and IX may be associated with an increased risk of thromboembolic complications4
  • Other risk factors that can contribute to thrombotic risk include5:
    • Older age
    • Traumatic injury
    • Surgical intervention
    • Pregnancy
    • Birth control pills
    • Being overweight or obese
    For every 100 IU of factor X in COAGADEX, there is <1 IU of factors II, VII, or IX2

References: 1. Data on file, BPL-RD050-0515. 2. COAGADEX® (Coagulation Factor X, Human) Prescribing Information. Durham, NC: BPL Limited. 2018. 3. Sorensen B, Spahn DR, Innerhofer P, et al. Crit Care. 2011;15:201. 4. Menegatti M, Peyvandi F. Semin Thromb Hemost. 2009;35:407-415. 5. Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/deep-vein-thrombosis/symptoms- causes/syc-20352557. Accessed May 4, 2018. 6. Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation. MASAC Document #253. https://www.hemophilia.org/Researchers-Healthcare-Providers/Medical-and-Scientific-Advisory-Council-MASAC/MASAC-Recommendations/MASAC-Recommendations-Concerning-Products-Licensed-for-the-Treatment-of-Hemophilia-and-Other-Bleeding-Disorders. Accessed November 20, 2018.

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

Please see complete Prescribing Information for COAGADEX.