In Clinical Studies, COAGADEX Was Proven Effective for Perioperative Treatment
Perioperative management
COAGADEX for Prevention of Bleeding During or After Surgery1
Major
Procedures
(in 2 subjects with mild factor X deficiency)
Bypass Graft
(x1 in 1 subject)
Replacement
(x2 in 1 subject)
Extractions
(6 extractions in
1 subject)
Minor
Procedures
(in 3 subjects with moderate or severe factor X deficiency)
(1 extraction in
2 subjects)
(2 extractions in
1 subject)
Subjects were given a pre-procedure loading dose to raise factor X level to 70-90 IU/dL, and were dosed post-procedure to maintain factor X level >50 IU/dL. Maximum permitted treatment duration for any subject was 21 days.
No post-operative bleeding- No requirement of blood transfusions
- Blood loss no more than as expected in patients without a bleeding disorder
Safety Findings1
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
Perioperative management of bleeding in patients with mild to severe hereditary factor X deficiency (Study TEN03).
A pooled analysis of five surgical patients aged 14-59 years with severe, moderate, or mild 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.
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.
