In Clinical Studies, COAGADEX Was Proven Effective for Routine Prophylaxis
to reduce the frequency of
The Efficacy of COAGADEX for Routine Prophylaxis Was Rated as Excellent by Investigators for All Subjects1
Routine prophylaxis to reduce the frequency of bleeding episodes (Study TEN02)
*Excellent = No minor or major bleeds occurred during the study period OR frequency of bleeds was lower than expected given subject’s medical/treatment history.
Study TEN02 was a prospective, open-label, multicenter, non-randomized phase III study of COAGADEX in the treatment of hereditary factor X deficiency in 9 children aged <12 years with severe (n=8) or moderate (n=1) factor X deficiency and baseline plasma factor X concentration <5 IU/dL (COAGADEX 40 to 50 IU/kg twice per week; frequency and dose adjusted through the first 6 weeks to maintain a trough factor X concentration >5 IU/dL). The primary endpoint was the investigators’ assessment of efficacy of prophylactic treatment in reducing or preventing bleeding over 6 months.
(Liesner R, et al. Haemophilia. 2018)
78% of subjects had no bleeds requiring replacement therapy while on study
Bleeds prior to study start:
- 3 subjects had a history of 1 bleed
- 6 subjects had a history of 2-7 bleeds*
- 6 subjects had no bleeds
- 1 subject had a minor cut/wound not requiring replacement therapy
- 2 subjects had multiple bleeds and received COAGADEX for 4 of them, which resolved (see table)
|Subject||Bleed Description†||Replacement Therapy Given|
|1 subject commenced menses shortly before the study, increasing expected frequency of on-study bleeds|
4 instances of menorrhagia (2 minor, 1 major, 1 not reported)All treated with tranexamic acid
|1 major bleed treated and resolved with COAGADEX|
|1 subject had 5 nosebleeds||5 nosebleeds (2 minor due to injury; 1 minor spontaneous; 2 major spontaneous after exercise)||3 spontaneous bleeds (1 minor, 2 major) treated and resolved with COAGADEX|
*Prior bleeds included all bleeds within 12 months prior to study entry and any severe or serious bleeds in the subject’s lifetime prior to first treatment with COAGADEX.
†Minor bleeds were defined as those that did not restrict the subject’s day-to-day life, or normal bleeding after injury. Major bleeds were defined as bleeds that restricted the subject’s day-to-day life, required immediate medical attention, or excessive traumatic bleeding.
Safety Findings for Study TEN02
None of the adverse events reported in Study TEN02 were considered related to COAGADEX treatment
- 28 adverse events were reported in 8 study subjects
- One subject experienced 2 serious adverse events requiring hospitalization (lower respiratory tract infection and influenza); both resolved
Reference: 1. Liesner R, et al. 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:
- 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.