In Clinical Studies, COAGADEX Was Proven Effective for Perioperative Treatment

Perioperative management

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Perioperative management of bleeding in patients with mild and moderate hereditary factor X deficiency
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COAGADEX Perioperative Efficacy Was Assessed as “Excellent” by Investigators for All Surgical Procedures in 5 Subjects Undergoing 7 Procedures1

Perioperative management of bleeding in patients with mild to severe hereditary factor X deficiency (Study TEN03)

Major
Procedures
(in 2 subjects with mild factor X deficiency)

Bypass icon
Coronary Artery
Bypass Graft
(x1 in 1 subject)
Knee icon
Total Knee
Replacement
(x2 in 1 subject)
Pliers and teeth icon
Multiple Tooth
Extractions
(6 extractions in
1 subject)

Minor
Procedures
(in 3 subjects with moderate or severe factor X deficiency)

Pliers and teeth icon
Tooth Extraction
(1 extraction in
2 subjects)
Pliers and teeth icon
Tooth Extraction
(2 extractions in
1 subject)

Investigators assessed COAGADEX as “Excellent” in preventing bleeding in all procedures in all 5 subjects—

  • No post-operative bleeding
  • No requirement of blood transfusions
  • Blood loss no more than “as expected”
Perioperative management of bleeding was studied in Study TEN03, a pooled analysis of five surgical patients aged 14-59 years with severe, moderate, or mild hereditary factor X deficiency from two similarly designed prospective, open-label, multicenter, non-randomized, phase III studies of COAGADEX in the treatment of factor X deficiency. Subjects 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. The primary endpoint was the investigators’ assessment of efficacy of perioperative treatment in prevention of bleeding.
(Escobar M, et al. Haemophilia. 2016)

Safety Findings for Study TEN03

Limitation of Use

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

Safety of COAGADEX in subjects 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

References: 1. Escobar M, et al. Haemophilia. 2016;22:713-720.

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:

  • Routine prophylaxis to reduce the frequency of bleeding episodes
  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding in patients with mild and moderate hereditary factor X deficiency

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 who have had life-threatening hypersensitivity reactions to COAGADEX.

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.