Routine Prophylaxis Trial Results: Efficacy

COAGADEX was studied in a prospective, open-label, multicenter, non-randomized phase III study in 9 children with severe (n=8) or moderate (n=1) factor X deficiency (Study TEN02)1

  • COAGADEX was administered with a recommended regimen of 40 to 50 IU/kg twice per week; frequency and dose were adjusted through the first 6 weeks of the study to maintain a trough factor X concentration >5 IU/dL
  • Treatment was continued for at least 26 weeks and at least 50 exposure days
  • Key inclusion criteria:
    • Aged <12 years
    • Baseline plasma factor X concentration <5 IU/dL
    • A history of severe bleeding or an F10 gene mutation known to cause a severe bleeding phenotype
  • Key exclusion criteria:
    • History of factor X inhibitor development
    • Known thrombocytopenia or clinically significant renal or liver disease
  • The primary endpoint was the investigators’ assessment of efficacy of prophylactic treatment in reducing or preventing bleeding over 6 months

The efficacy of COAGADEX for prophylaxis was rated as excellent by investigators for all pediatric subjects1

Efficacy of COAGADEX for Routine Prophylaxis

100% of investigators rated the efficacy of COAGADEX for prophylaxis as excellent*
*Excellent = No minor or major bleeds occurred during the study period OR lower frequency of bleeds than expected given subject’s medical/treatment history.
  • Overall, 537 prophylactic infusions were administered
    • Mean dose per subject per infusion = 38.8 IU/kg
  • Factor X activity (or FX:C) trough levels were maintained at >5 IU/dL after visit 4 (days 29–42) in all subjects

78% of subjects had no bleeds requiring replacement therapy while on-study1

  • Four bleeds in 2 subjects were treated with COAGADEX
  • All bleeds were treated with a single infusion of COAGADEX

References: 1. Liesner R, Akanezi C, Norton M, Payne J. Haemophilia. 2018;24(6):941-949.

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.