In Clinical Studies, COAGADEX Was Proven Effective for On-demand Treatment
On-demand treatment
treatment and control
of bleeding episodes
COAGADEX for On-demand Treatment of Bleeds1
Menorrhagic and joint bleeds comprised about two-thirds of the 187 analyzed bleeds*
*34% (n=63) were “Other Bleeds”, which included mucosal (non-menorrhagic), muscle, cut/wound, concussion, and others.
From a total of 187 bleeds assessed, 155 bleeds were treated with 1 infusion, 28 were treated with 2 infusions, and 4 were treated with 3 or 4 infusions of COAGADEX.
Safety Findings1
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
- No serious AEs were considered by investigators to be related to COAGADEX
- One serious AE of death occurred due to pneumonia and nosocomial infection
On-demand treatment and control of bleeding episodes (Study TEN01).
A prospective, open-label, multicenter, non-randomized phase III study of COAGADEX in the treatment of 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 activity level <5 IU/dL. Bleeds assessed included overt (external) bleeds, covert (internal) bleeds, and menorrhagic bleeds. The primary endpoint result was 98% of investigator-assessed bleeds were rated as having an “excellent” or “good” response to treatment with COAGADEX.
COAGADEX for On-demand Treatment in Women and Girls (Post Hoc Analysis)2
were treated successfully with COAGADEX
80% (8/10) of the women and girls had a history
of heavy menstrual bleeding at baseline*
Key stats:
- 97% (128/132) of bleeds were either heavy menstrual bleeding or internal bleeds
- 46% (61/132) of bleeds were heavy menstrual bleeding
- 50% (5/10) had a history of blood transfusions to treat heavy menstrual bleeding
- 40% (4/10) had a history of anemia
Safety Findings Reported for Women and Girls2
Six adverse 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
On-demand treatment and control of bleeding episodes in women and girls.
A post-hoc subanalysis was conducted of the 10 women and girls who were enrolled in Study TEN01; 62.5% (10/16) of subjects enrolled were women and girls aged 13-65 years. A total of 132 bleeds treated with COAGADEX were included in the primary efficacy analysis. The treatment success rate was defined as receiving a rating of “excellent” or “good” response to treatment with COAGADEX, of which 129/132 bleeds were treated successfully.
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, moderate and severe hereditary factor X deficiency
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.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch, or call 1-800-FDA-1088.
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