In Clinical Studies, COAGADEX Was Proven Effective for Routine Prophylaxis
Routine prophylaxis
to reduce the frequency of
bleeding episodes
COAGADEX Twice Weekly for Prophylaxis1
COAGADEX was administered twice weekly for prophylaxis in 9 children with moderate or severe hereditary factor X deficiency. Dosing was adjusted to maintain trough factor X activity levels >5 IU/dL; all subjects maintained trough levels >5 IU/dL after Visit 4 (Days 29-42).
During the study period on twice-weekly prophylaxis, seven of nine patients (78%) had zero bleeds requiring replacement therapy while taking twice-weekly prophylaxis. Two of nine patients had bleeds requiring replacement therapy (range: 4-5 bleeds in 2 subjects). In the 12 months prior to the study, all nine subjects had bleeds, or at least one serious bleed in their lifetime (range: 1-7 bleeds).
Safety Findings1
None of the adverse events reported in the study 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
- No evidence of inhibitor development was observed
Routine prophylaxis to reduce the frequency of bleeding episodes (Study TEN02).
A prospective, open-label, multicenter, non-randomized phase III study of COAGADEX in the treatment of 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 activity level <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 activity level >5 IU/dL). The primary endpoint was the investigators’ assessment of efficacy of prophylactic treatment in reducing or preventing bleeding over 6 months; ratings for all subjects were “excellent”. Criteria for assessment included no minor or major bleeds occurred during study treatment or lower frequency of bleeds than expected given subject’s medical history.
Long-Term Use: COAGADEX Prophylaxis Compared with On-demand Treatment2
Bleeds in Patients with Hereditary Factor X Deficiency Receiving COAGADEX On-demand vs Prophylaxis
*Includes 1 patient who alternated between on-demand treatment (~10 months with 6 bleeds) and routine prophylaxis (~12 months with 0 bleeds).
Patients experienced 88 bleeds in the study. The overall median bleed rate per patient was equivalent to 0.8 bleeding episodes per patient per month in the on-demand group (based on 71 bleeds in eight patients) and equivalent to 0.04 bleeding episodes per patient per month in the routine prophylaxis group (based on 17 bleeds in four patients).
- Menorrhagic and joint bleeds comprised about 60% of the 88 on-study bleeds†
- Median study treatment duration was 1.6 years with a range of up to 4 years
Safety Findings2
- No adverse events/thrombotic events, safety concerns, infusion-site reactions, tolerability issues or inhibitor development were reported in use up to 4 years
- Two patients reported successful pregnancies and childbirths, with no abnormal bleeding complications or safety concerns
Long-term use of COAGADEX in patients with factor X deficiency (Study TEN05).
An open-label, long-term, multicenter, retrospective analysis of 15 subjects aged 1-43 years (13 subjects ≥12 years) with predominantly severe (n=12) hereditary factor X deficiency receiving compassionate use COAGADEX for routine prophylaxis (n=7), on-demand treatment (n=7), or alternating routine prophylaxis/on-demand treatment (n=1). Three subjects on routine prophylaxis also received COAGADEX for perisurgical hemostatic cover, and 6 subjects received short-term preventative COAGADEX treatment including 3 receiving routine prophylaxis, 2 receiving on-demand treatment, and 1 receiving alternating prophylaxis/on-demand treatment. All dosing was per investigator discretion, individually tailored to the patient. Median (range) duration of compassionate use was 1.6 (0.3–4.0) years. Efficacy endpoints included treatments administered, bleed number and treatment, and investigator assessments.
†40% (n=35) were other bleeds, which included mucosal (non-menorrhagic), muscle, renal, subdural hematoma, vaginal, and others, including 2 not recorded.
Reference: 1. Liesner R, et al. Haemophilia. 2018;24(6):941-949. 2. Huang JN, et al. Res Pract Thromb Haemost. 2021;5:e12550. doi: 10.1002/rth2.12550.
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.
