Results in Patients Undergoing Surgery

Five patients receiving COAGADEX in clinical trials underwent 7 surgical procedures

  • Three of the patients were enrolled in Study Ten 01
  • Two patients were enrolled in Study Ten 03, a non-randomized, prospective study in patients with mild to severe factor X deficiency (plasma concentration of factor X <20 IU/dL) undergoing planned surgery. Both patients in Study Ten 03 had 2 separate surgical procedures

    Investigator-Assessed Outcome of Surgery in Patients Receiving COAGADEX

    Patients were given a loading dose before the procedure to raise factor X level to 70-90 IU/dL. Doses after surgery were given to maintain factor X level above 50 IU/dL.

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

Safety of COAGADEX in patients undergoing surgery

  • The most common AEs, each reported on 3 occasions, were constipation and dyspepsia; all other AEs were reported on ≤2 occasions. No AE was considered related to treatment with COAGADEX
  • Two serious AEs were reported (tooth abscess predating surgical procedure; hospitalization due to bleeding following a complex procedure requiring intravenous anesthesia and intubation to extract 2 teeth). Neither serious AE was considered related to COAGADEX
  • No thrombotic events or other evidence of thrombogenicity were reported
  • All inhibitor results were negative
  • No viral seroconversions were observed

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

Reference: Escobar M, Auerswald G, Austin S, et al. Efficacy and safety of FACTOR X, a new high-purity factor X concentrate, in subjects with factor X deficiency undergoing surgery. Poster presented at the 9th Annual Scientific Symposium of the Hemostasis and Thrombosis Research Society (HTRS), New Orleans, April 16-18 2015.

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.