In Clinical Studies, COAGADEX Was Proven Effective for On-demand Treatment
On-demand treatment
treatment and control
of bleeding episodes
98% of Bleeding Episodes Were Successfully Treated with COAGADEX, as Rated by Investigators (Excellent or Good Response)1
On-demand treatment and control of bleeding episodes (Study TEN01)
- 83% of bleeds required 1 infusion only to control bleeding
- 98% of bleeds controlled with 1 or 2 infusions of COAGADEX
| n (%) of bleeds N=187 | |
|---|---|
| Bleed type | |
| Covert | 110 (58.8) |
| Menorrhagic | 61 (32.6) |
| Overt | 16 (8.6) |
| Bleed location | |
| Mucosal | 73 (39.0) |
| Joint | 63 (33.7) |
| Muscle | 26 (13.9) |
| Other* | 25 (13.4) |
| Bleed cause | |
| Spontaneous | 79 (42.2) |
| Menorrhagia | 61 (32.6) |
| Injury | 47 (25.1) |
| Bleed severity† | |
| Major | 98 (52.4) |
| Minor | 88 (47.1) |
| Not evaluated | 1 (0.5) |
| Number of infusions | n (%) of bleeds N=187 |
|---|---|
| 1 | 155 (82.9) |
| 2 | 28 (15.0) |
| 3 or 4 | 4 (2.1) |
*There were 228 bleeds in the study. Of these, 20 bleeds did not require replacement therapy, 21 bleeds were not reviewed or were considered unassessable by the Data Review Committee (DRC) due to insufficient information and/or protocol violations, and the remaining 187 bleeds were judged by the DRC as able to be included for analysis.
Study TEN01 was a prospective, open-label, multicenter, non-randomized phase III study of COAGADEX in the treatment of hereditary factor X deficiency in 16 children and adults (male and female) aged 12–58 years with severe or moderate factor X deficiency and baseline plasma factor X concentration <5 IU/dL (COAGADEX 1 or 2 infusions with mean (SD) dose per infusion of 25.3 (2.5) IU/kg, administered on-demand or for short-term prophylaxis for 6 months to 2 years until ≥12 bleeding episodes had been treated). The primary endpoint was the investigators’ assessment at end of study of efficacy of on-demand treatment or short-term prophylaxis. Rating scale for treatment response: Excellent = For overt bleed, bleeding stopped within 12 h after dosing with factor X concentrate (FX), with only 1 dose required. For covert bleed, 1 dose of FX was required or 2 doses of FX were required less than 48 h apart. For menorrhagic bleed, 1 dose of FX was required or 2 doses of FX were required less than 48 h apart. Good = For overt bleed, bleeding stopped within 24 h after the first dose of factor X concentrate (FX), with 1 or 2 doses required. For covert bleeds, 3 doses of FX were required, with less than 48 h between the first and last dose. For menorrhagic bleeds, 2 doses of FX were required, with more than 48 h between the first and last dose.
(Austin S, et al. Haemophilia. 2016)
Women and Girls Reported a 98% COAGADEX Treatment Success Rate (Excellent or Good Response)2
On-demand treatment and control of bleeding episodes in women and girls (subanalysis of Study TEN01)
Type of bleed assessed (n=132 bleeds)
Baseline characteristics of women and girls
Safety Findings for Study TEN011,2
Six adverse events (3.4% of all reported events) occurring in 2 subjects were considered by the investigator to be possibly related to treatment with COAGADEX
- Infusion-site erythema (2 mild events), back pain (1 mild event), and fatigue (1 mild event and 1 moderate event) in 1 subject
- Predose infusion-site pain (1 mild event) in 1 subject
Six of 16 subjects (37.5%) experienced a total of 13 serious adverse events (AEs)
- No serious AEs were considered by investigators to be related to COAGADEX
- One serious AE of death occurred due to pneumonia and nosocomial infection
Other safety results
- No thrombotic events or clinical signs of thrombogenicity
- No hypersensitivity reactions to factor X
- No evidence of inhibitors to factor X
- No viral seroconversions were observed
References: 1. Austin S, et al. Haemophilia. 2016;22:419-425. 2. Kulkarni R, et al. J Thromb Haemost. 2018;16:849-857.
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.