COAGADEX Is the First and Only Approved Treatment Specifically for Hereditary Factor X Deficiency
COAGADEX is high purity—containing the highest percentage of factor X available1
*Plasma-derived factor X concentrate. COAGADEX is the only FDA-licensed, plasma-derived factor X concentrate.
COAGADEX Is the First and Only Approved Treatment Developed to Replace Exactly What Patients Are Missing—Factor X3
Before the availability of COAGADEX, hereditary factor X deficiency was often treated with prothrombin complex concentrates (PCCs), which contain a mix of 3 or 4 clotting factors.
- PCCs are manufactured based on a factor IX assay, and the amount of factor II, VII, and X in a vial can vary considerably between products and between lots of the same product4
- Kcentra®, Profilnine SD®, and FEIBA are examples of PCCs and contain a mix of factors II, VII, IX, and X4,5
Factor Content of COAGADEX vs Selected Factor X-Containing PCC Products1,4
IU of Factors X, IX, VII, and II Relative to 100 IU of Reference Assay Factor*
COAGADEX
(Single-Factor Concentrate)
(Single-Factor Concentrate)
Kcentra®
(PCC)
(PCC)
Profilnine SD®
(PCC)
(PCC)
*COAGADEX is manufactured using factor X as the reference assay factor.
Kcentra and Profilnine SD are manufactured using factor IX as the reference assay factor; data are from testing of specific batches at the time the article was written.
Elevated levels of factors II, VII, and IX in the blood may be associated with an increased risk of thromboembolic complications6
Other risk factors that can contribute to thrombotic risk include:
- Older age
- Traumatic injury
- Surgical intervention
- Pregnancy
- Birth control pills
- Being overweight or obese
Pharmacokinetics of COAGADEX3
Pharmacokinetic parameters:
- Mean half-life: 30.3 hours in adults*
- Mean incremental recovery in adults: 2.04 IU/dL per IU/kg*
Based on COAGADEX Pharmacokinetics—Twice Weekly Dosing Is Recommended for Prophylactic Therapy
Factor X Plasma Concentrations Following COAGADEX Administration7
- For prohylaxis, the dose of COAGADEX should be adjusted to maintain trough levels ≥5 IU/dL
- Further adjustment may be needed to maintain FX:C at levels considered appropriate for the patient
COAGADEX Dosing Instructions3
- COAGADEX dosage and duration of treatment depend on the severity of the factor X deficiency, the location and extent of bleeding, and the patient’s clinical condition
- See dosing instructions below. Base dose and frequency on individual clinical response. Do not administer more than 60 IU/kg daily. Do not exceed a peak blood level of factor X of 120 IU/dL
Age | Initial Dose | Further Management |
---|---|---|
<12 years | 40 IU/kg twice weekly | Monitor trough blood levels of factor X targeting ≥5 IU/dL and adjust dosage to clinical response and trough levels. Do not exceed a peak level of 120 IU/dL |
≥12 years | 25 IU/kg twice weekly |
Age | Initial Dose | Further Management |
---|---|---|
<12 years | 30 IU/kg | Repeat at intervals of 24 hours until the bleed stops |
≥12 years | 25 IU/kg |
Age | Initial Dose | Further Management |
---|---|---|
<12 years | Use a factor of 0.6 to calculate the required dose* | Pre-surgery: raise plasma factor X levels to 70-90 IU/dL Post-surgery: maintain plasma factor X levels at ≥50 IU/dL until the patient is no longer at risk of bleeding due to surgery |
≥12 years | Use a factor of 0.5 to calculate the required dose† |
*Dose (IU) = body weight (kg) x desired factor X rise (IU/dL or % of normal) x 0.6
†Dose (IU) = body weight (kg) x desired factor X rise (IU/dL or % of normal) x 0.5
COAGADEX Reconstitution Instructions
COAGADEX Viral Inactivation Steps3,8
COAGADEX is manufactured from plasma obtained from healthy US donors who have passed viral screening tests
During the manufacturing process, COAGADEX undergoes 3 processing steps specifically designed to remove or inactivate enveloped and non-enveloped viruses
Tests for prion protein reduction have reported an overall decrease of >9.2 log10: 2.5 log10 with metal chelate chromatography, >3.7 log10 with anion exchange chromatography, and 3.0 log10 for virus filtration.
References: 1. Data on file, BPL-RD050-0515. 2. Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation. MASAC Document #263. https://www.hemophilia.org/healthcare-professionals/guidelines-on-care/masac-documents/masac-document-263-masac-recommendations-concerning-products-licensed-for-the-treatment-of-hemophilia-and-other-bleeding-disorders. Accessed June 22, 2021. 3. COAGADEX® (Coagulation Factor X, Human) Prescribing Information. Durham, NC: BPL Limited. 2018. 4. Sorenson B, Spahn DR, Innerhofer P, et al. Crit Care. 2011;15:201. 5. Awad NI, Cocchio C. P&W. 2013;38(11):696-701. 6. Menegatti M, Peyvandi F. Semin Thromb Hemost. 2009;35:407-415. 7. Austin SK, et al. Haemophilia. 2016;22:426-432. 8. Austin SK, Kavakli K, Norton M, et al. Haemophilia. 2016;22:419-425.
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.