On-demand treatment
COAGADEX Effectively Controlled Bleeds with On-Demand Use
On-demand efficacy of COAGADEX was evaluated by investigators in a prospective, open-label, multicenter, non-randomized phase III study in 16 children and adults with HFXD treated on-demand for ≥6 months and up to 24 months1
- All patients were <5 IU/dL at baseline, with 88% <1 IU/dL
- Mean age was 27 years; 6 patients were <18 years; 63% were female
- Patients had 35 bleeds pre-study: 9 joint, 8 muscle, 7 menorrhagia, 11 other*
Results
98% of bleeds were controlled with 1 or 2 infusions of COAGADEX
Required to Control Bleeds (N=187 analyzed bleeds)
Safety Findings
- 6 AEs (3.4%) in 2 female patients were considered by the investigator as possibly related to COAGADEX (fatigue, infusion site erythema, back pain, infusion site pain)
- All inhibitor results were negative, no viral seroconversions were detected and no suspected hypersensitivity reactions to COAGADEX were observed. No clinical symptoms suggestive of thrombosis were seen
- AEs, adverse events.
- *Included bleeds that occurred in the 12 months prior to the study plus any significant bleeds in a subject’s lifetime.
COAGADEX Women and Girls Cohort
Using a female cohort from the on-demand study, a post-hoc analysis evaluated COAGADEX in 10 women and girls with HFXD who had ≥ 1 spontaneous or menorrhagic bleed requiring treatment in the 12 months prior to study entry2
- All patients were <5 IU/dL at baseline
- Median age of 25.5 years with range of 14-58 years
- 80% had history of heavy menstrual bleeding
- 50% had blood transfusions to treat heavy menstrual bleeds
- 40% had history of anemia
Results
- Of 132 assessable bleeds:
55% (73/132) were
major bleeds
46% (61/132) were heavy
menstrual bleeds
36% (47/132) were
joint bleeds - Mean number of COAGADEX infusions to control menstrual bleed: 1.25 (range 1-3 infusions)
Safety Findings
- 6 AEs (3.4%) in 2 female patients were considered by the investigator as possibly related to COAGADEX (fatigue, infusion site erythema, back pain, infusion site pain)
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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