Hereditary Factor X Deficiency (HFXD)

Factor X is a critical component of the blood coagulation cascade, making HFXD one of the most severe bleeding disorders^1,2

Factor X coagulation cascade diagram showing intrinsic, extrinsic, and common pathways — Coagulation Cascade²

Adapted from: LearnHaem, Haematology made simple. 4 Nov. 2020. Accessed October 2, 2025. www.learnhaem.com/courses/coagulation/lessons/normal-haemostasis/topic/the-revised-coagulation-cascade/.

“Due to the critical role that factor X plays in the coagulation cascade, factor X deficiency is associated with a higher risk of bleeding than deficiencies in other coagulation factors.”³

— Tarantino MD. Haemophilia. 2021;27(4):531-543.

aPTT, activated partial thromboplastin time; PT, prothrombin time.

HFXD Is One of the Most Prevalent Rare Bleeding Disorders

If hemophilia and von Willebrand disease have been excluded in a patient with bleeding symptoms —
The patient may have an underlying rare bleeding disorder, such as Hereditary Factor X Deficiency (HFXD)^4,5

1 in 16 rare bleeding disorders are due to Hereditary Factor X Deficiency

1 in 500 people are estimated to be carriers for HFXD⁷
As an autosomal recessive disorder, HFXD affects females and males equally^7,8
HFXD may cause particularly severe or life-threatening symptoms^3,7,8

HFXD symptoms can vary and may present across the lifespan^3,7

Prompt diagnosis and appropriate treatment may help prevent permanent impairment or mortality

Learn More About Hereditary Factor X Deficiency Symptoms

References: 1. National Institutes of Health. Doherty T, et al. Bleeding disorders. StatPearls [Internet]. https://www.ncbi.nlm.nih.gov/books/NBK541050/. Updated April 3, 2023. Accessed August 24, 2023. 2. LearnHaem, Haematology made simple. 4 Nov. 2020. Accessed October 2, 2025. https://www.learnhaem.com/courses/coagulation/lessons/normal-haemostasis/topic/the-revised-coagulation-cascade/. 3. Tarantino MD. Haemophilia. 2021;27(4):531-543. doi: 10.1111/hae.14223. 4. Kamal AH, et al. Mayo Clin Proc. 2007;82(7):864-873. 5. Palla R, et al. Blood. 2015;125(13):2052-2061. 6. Menegatti M, Peyvandi F. Thromb Hemost. 2024 Aug 29. doi: 10.1055/s-0044-1789595. Epub ahead of print. 7. Peyvandi F, et al. Blood Reviews. 2021;50:100833. 8. Peyvandi F, Palla R, et al. J Thromb Haemost. 2012;10:615-621. 9. Branchford B, et al. Blood Coagul Fibrinolysis. 2024;35(3):73-81. 10. Herrmann FH, et al. Haemophilia. 2006;12:479-489. 11. Byams V, et al. J Women’s Health. 2022;31(3):301-309. 12. Shapiro A. Expert Opin Drug Metab Toxicol. 2017;13(1):97-104. 13. National Organization for Rare Disorders. Updated June 6, 2023. Accessed October 25, 2024. https://rarediseases.org/rare-diseases/factor-x-deficiency/. 14. Medline Plus. https://medlineplus.gov/genetics/condition/von-willebrand-disease/#synonyms. Updated August 8, 2023. Accessed November 1, 2024. 15. LabCorp. https://www.labcorp.com/tests/086306/factor-x-activity. Accessed November 5, 2024. 16. Peyvandi F, et al. Brit J Haematol. 1998;102:626-628. 17. Peyvandi F, et al. J Thromb Haemost. 2012;10:1938-1943. 18. Srivastava A, et al. Haemophilia. 2020;26(Suppl 6):1-158. doi: 10.1111/hae.14046. 19. Medical and Scientific Advisory Council (MASAC) of the National Bleeding Disorders Foundation. MASAC Document #290. https://www.bleeding.org/healthcare-professionals/guidelines-on-care/masac-documents/masac-document-290- masac-recommendations-concerning-products-licensed-for-the-treatment-of-hemophilia-and-selected-disorders-of-the-coagulation-system. Accessed March 31, 2025. 20. Escobar M, Kavakli K. Haemophilia. 2024;30:59-67.

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.
You may also call Kedrion at 1-866-398-0825 or email US_Medicalinfo@kedrion.com.