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

Pie chart showing 94% of protein in COAGADEX is factor X
COAGADEX* is the only treatment recommended by the National Hemophilia Foundation’s Medical and Scientific Advisory Council (MASAC) for hereditary factor X deficiency2

*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)

Pie chart showing Factor X = 100 IU, Factor IX = <1 IU, Factor VII <1 IU, Factor II <1 IU.

Kcentra®
(PCC)

Pie chart showing Factor X = 152 IU, Factor IX = 100 IU, Factor VII = 68 IU, Factor II = 128 IU.

Profilnine SD®
(PCC)

Pie chart showing Factor X = 64 IU, Factor IX = 100 IU, Factor VII = 11 IU, Factor II = 148 IU.

*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

Graph depicting the curve of factor X plasma concentrations after Coagadex administration with peaks within 1/2 hour of dosing and a half life of 30.3 hours.
*Single 25 IU/kg dose to subjects 12 years of age and older.
  • 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
For prophylaxis of bleeding episodes
AgeInitial DoseFurther Management
<12 years40 IU/kg twice weeklyMonitor 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 years25 IU/kg twice weekly
For treatment of bleeding episodes
AgeInitial DoseFurther Management
<12 years30 IU/kgRepeat at intervals of 24 hours until the bleed stops
≥12 years25 IU/kg
For perioperative management
AgeInitial DoseFurther Management
<12 yearsUse 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 yearsUse 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

Beaker icon
1. Solvent/​detergent treatment targeting enveloped viruses
arrow pointing to step 2
Filtration icon
2. A 15-nm filtration step designed to remove small viruses including non-enveloped viruses
arrow pointing to step 3
Heat rising icon
3. Terminal dry-heat treatment at 80◦C for 72 hours in the final container to inactivate enveloped and non-enveloped viruses
arrow pointing to the final product
Coagadex vial
Final product

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.

Please see complete Prescribing Information for COAGADEX.