Factor X

COAGADEX temporarily replaces the missing Factor X needed for effective hemostasis. Factor X is an inactive zymogen, which can be activated by Factor IXa (via the intrinsic pathway) or by Factor VIIa (via the extrinsic pathway).

• COAGADEX, Coagulation Factor X (Human), is a plasma-derived human blood coagulation Factor 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 COAGADEX, Coagulation Factor X (Human), is a plasma-derived human blood coagulation factor indicated in adults and children with hereditary Factor X deficiency for: Routine prophylaxis to reduce the frequency of bleeding episodes ( 1 ) On-demand treatment and control of bleeding episodes ( 1 ) Perioperative management of bleeding in patients with mild, moderate and severe hereditary Factor X deficiency ( 1 )

• COAGADEX is contraindicated in patients who have had life-threatening hypersensitivity reactions to COAGADEX [ see Description (11) ]. Do not use in patients who have had life-threatening hypersensitivity reactions to COAGADEX ( 4 ).contraindicated

For intravenous use after reconstitution only For intravenous use only after reconstitution. Each vial of COAGADEX contains the labeled amount of Factor X in international units (IU) ( 2 ) The dosage and duration of treatment depend on the severity of the Factor X deficiency, the location and extent of the bleeding and the patient's clinical condition ( 2.1 ) For prophylaxis of bleeding episodes ( 2.1 ): Age Initial dose Further management Children: Less than 12 years of age 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. Adults and adolescents: 12 years of age or older 25 IU/kg twice weekly For treatment of bleeding episodes ( 2.1 ): Age Initial dose Further management Children: Less than 12 years of age 30 IU/kg Infuse at first sign of bleeding. Repeat at intervals of 24 hours until the bleed stops. Adults and adolescents: 12 years of age or older 25 IU/kg For perioperative management ( 2.1 ): Age Initial dose Further management Children: Less than 12 years of age 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.

Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue COAGADEX and administer appropriate treatment ( 5.1 ). Development of neutralizing antibodies (inhibitors) may occur. If expected plasma Factor X activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures Factor X inhibitor concentration ( 5.2 ). COAGADEX is made from human blood and therefore carries a risk of transmitting infectious agents, e.g. viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent ( 5.4 ). 5.1 Hypersensitivity Reactions Allergic type hypersensitivity reactions, including anaphylaxis, are possible. Early signs of hypersensitivity reactions including angioedema, infusion site inflammation (e.g. burning, stinging, erythema), chills, cough, dizziness, fever, flushing, generalized urticaria, headache, hives, hypotension, lethargy, musculoskeletal pains, nausea, pruritus, rash, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing. If hypersensitivity symptoms occur, discontinue use of the product immediately and administer appropriate emergency treatment. COAGADEX contains traces of human proteins other than Factor X. 5.2 Neutralizing Antibodies The formation of neutralizing antibodies (inhibitors) to Factor X may occur. Monitor all patients treated with COAGADEX for the development of inhibitors by appropriate clinical observations and laboratory tests.

The most common adverse drug reactions (frequency ≥ 5% of subjects) observed in clinical trials were infusion site erythema, infusion site pain, fatigue, and back pain. The most common adverse drug reactions (frequency ≥ 5% of subjects) observed in clinical trials were infusion site erythema, infusion site pain, fatigue and back pain ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Kedrion Biopharma, Inc. at 1-855-3KDRION (1-855-353-7466) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience As clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in clinical practice. During the clinical development of COAGADEX involving three multicenter, open-label, non-randomized clinical studies, 27 individual subjects with hereditary Factor X deficiency received at least one dose of COAGADEX. Sixteen subjects aged 12 to 58 years with moderate to severe hereditary Factor X deficiency (basal FX:C < 5 IU/dL) received doses of COAGADEX for pharmacokinetic evaluation, on-demand treatment for control of bleeding episodes, and/or perioperative management of minor surgical or dental procedures. A total of 468 infusions were administered, including 242 for on-demand treatment and control of bleeding episodes, 6 for perioperative management and 31 for PK assessments.

8.1 Pregnancy Risk Summary There is limited data with COAGADEX in pregnant women to inform on drug-associated risk. Animal reproduction studies have not been conducted using COAGADEX. It is not known whether COAGADEX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. 8.2 Lactation Risk Summary There is no information regarding the presence of COAGADEX in human milk, the effects on the breast-fed infant, or the effects on milk production. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for COAGADEX and any potential adverse effects on the breast-fed infant from COAGADEX or from the underlying maternal condition. 8.4 Pediatric Use A prospective, open-label, multicenter study was conducted in nine pediatric patients (0-5 years, n=4; 6-11 years, n=5) with severe (n=8) or moderate (n=1) hereditary factor X deficiency, to assess safety, efficacy, and pharmacokinetics of COAGADEX used prophylactically and on-demand. Patients had baseline FX levels < 5 IU/dL, and were dosed to achieve post-treatment levels of at least 5 IU/dL.

Metabolism

In a clinical study of COAGADEX in subjects with severe or moderate Factor X deficiency (basal FX:C < 5 IU/dL), the pharmacokinetics of COAGADEX were assessed after intravenous infusion (mean [range] infusion rate 5.9 [1.3-17.1] mL/min) of 25 IU/kg COAGADEX. Pharmacokinetic (PK) parameters were calculated from plasma Factor X:C activity measurements after subtraction of the pre-dose value.

One case of accidental overdosage was reported in the clinical trials, in which a subject received approximately 80 IU/kg Factor X to treat a bleed. No adverse events were reported relating to this overdose.

1. 1Death824%
2. 2Arthralgia515%
3. 3Abdominal Pain26.1%
4. 4Cough26.1%
5. 5Dizziness26.1%
6. 6Off Label Use26.1%
7. 7Urticaria26.1%
8. 8Aphasia13.0%
9. 9Atrioventricular Block Complete13.0%
10. 10Bacteraemia13.0%
11. 11Balance Disorder13.0%
12. 12Cardiac Failure13.0%
13. 13Circulatory Collapse13.0%
14. 14Cyanosis13.0%
15. 15Drug Ineffective13.0%

Recent PubMed references pinned to Factor X as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Residue‑resolved dynamically averaged interaction analysis of direct factor Xa inhibitors by MD‑FMO combination calculations.
  Journal of computer-aided molecular design · 2026 · Yoshine R, Hirano Y, Doi H, et al.
  PMID 42213187DOI 10.1007/s10822-026-00846-x
• Molecular Modeling of Protein-Peptide Complexes Mimicking Factor Xa-Prothrombin Using AlphaFold-Multimer and Molecular Dynamics Simulations for Functional Prediction.
  Journal of chemical information and modeling · 2026 · Veizaj D, Poole DA 3rd, Cheung KL, et al.
  PMID 42176283DOI 10.1021/acs.jcim.5c02774
• Andexanet alfa for the reversal of anticoagulation: Dutch practice data.
  Research and practice in thrombosis and haemostasis · 2026 · Krommenhoek JF, Beekman W, Kor F, et al.
  PMID 42088901DOI 10.1016/j.rpth.2026.103438
• Emergency reversal of Rivaroxaban with Andexanet alfa in a child with hemorrhagic brain metastasis from Wilms tumor.
  Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2026 · Rafaelian A, Won SY, Mueller L, et al.
  PMID 42069956DOI 10.1007/s00381-026-07286-w
• TFPIα inhibition by andexanet alfa is partially restored by protein S and factor V-short.
  Blood advances · 2026 · Crossette-Thambiah C, Bamberg K, Laffan M, et al.
  PMID 41962001DOI 10.1182/bloodadvances.2026020160
• Peptide Angio-3 Attenuates Pulmonary Fibrosis Via Modulation of the Coagulation Factor Xa-Protease-Activated Receptor-1 Signaling Axis.
  FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2026 · Wang D, Li F, Chen H, et al.
  PMID 41902413DOI 10.1096/fj.202504506R
• Disseminated Intravascular Coagulation Following Idarucizumab and Andexanet Alfa: Assessment of a Signal of Disproportionate Reporting From the Food and Drugs Administration Adverse Event Reporting System (FAERS) Database.
  Drug safety · 2026 · Roberto G, Parmeggiani L, Flaccavento A, et al.
  PMID 41865355DOI 10.1007/s40264-026-01648-8
• The sting that clots: The Factor VII and Factor X activating procoagulant effects of Androctonus scorpion venoms are potentiated by Factor Va as a cofactor.
  Biochimie · 2026 · Campbell SID, Seneci L, Jones L, et al.
  PMID 41740918DOI 10.1016/j.biochi.2026.02.018

The 10 most recently updated of 505 ClinicalTrials.gov registrations naming Factor X as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia
  Recruiting · Phase 1 · Interventional · 47 enrolled · National Cancer Institute (NCI)
  NCT07012044updated 2026-06-12
• Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-Linked Chronic Granulomatous Disease
  Recruiting · Phase 1 · Phase 2 · Interventional · 10 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT06325709updated 2026-06-11
• Fecal Microbiota Transplantation in Patients Undergoing Chimeric Antigen Receptor T-cell Therapy and Allogeneic Stem Cell Transplant: A Pilot Study
  Recruiting · Interventional · 20 enrolled · University Health Network, Toronto
  NCT07509450updated 2026-06-11
• Testing Blinatumomab With or Without Revumenib in Patients With B-cell Acute Lymphoblastic Leukemia With a Genetic Change Requiring More Treatment
  Not yet recruiting · Phase 2 · Interventional · 90 enrolled · SWOG Cancer Research Network
  NCT07636564updated 2026-06-09
• Imaging CRF X NOP Interactions in CUD
  Recruiting · Early phase 1 · Interventional · 80 enrolled · Rajesh Narendran
  NCT05008146updated 2026-06-09
• Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia
  Recruiting · Phase 2 · Interventional · 80 enrolled · Children's Oncology Group
  NCT02981628updated 2026-06-05
• Neoadjuvant Intra-tumoral RP2 and FLOT in Gastroesophageal Adenocarcinoma
  Not yet recruiting · Phase 2 · Interventional · 34 enrolled · Abramson Cancer Center at Penn Medicine
  NCT07059611updated 2026-06-05
• Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)
  Recruiting · Phase 1 · Phase 2 · Interventional · 40 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT01306019updated 2026-06-05
• Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity
  Active not recruiting · Phase 2 · Interventional · 75 enrolled · National Cancer Institute (NCI)
  NCT00092222updated 2026-06-05
• MT2023-20: Hematopoietic Cell Transplant With Reduced Intensity Conditioning and Post-transplant Cyclophosphamide for Severe Aplastic Anemia and Other Forms of Acquired Bone Marrow Failure.
  Recruiting · Phase 2 · Interventional · 60 enrolled · Masonic Cancer Center, University of Minnesota
  NCT06412497updated 2026-06-03

Frequently asked questions

How does Factor X work?

COAGADEX temporarily replaces the missing Factor X needed for effective hemostasis. Factor X is an inactive zymogen, which can be activated by Factor IXa (via the intrinsic pathway) or by Factor VIIa (via the extrinsic pathway).

What is Factor X used for?

According to FDA labeling, Factor X carries indications including: COAGADEX, Coagulation Factor X (Human), is a plasma-derived human blood coagulation Factor 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 COAGADEX, Coagulation Factor X (Human), is a plasma-derived human blood coagulation factor indicated in adults and children with hereditary Factor X deficiency for: Routine prophylaxis to reduce the frequency of bleeding episodes ( 1 ) On-demand treatment and control of bleeding episodes ( 1 ) Perioperative management of bleeding in patients with mild, moderate and severe hereditary Factor X deficiency ( 1 ). This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Factor X?

Factor X is classified as Blood coagulation factors, Enzyme Activators, Increased Coagulation Activity, Increased Coagulation Factor Activity, Increased Coagulation Factor Concentration.

What are the brand names for Factor X?

Factor X is marketed under brand names including Balfaxar, Coagadex, Kcentra.

What are the contraindications for Factor X?

Factor X labeling lists contraindications including: COAGADEX is contraindicated in patients who have had life-threatening hypersensitivity reactions to COAGADEX [ see Description (11) ]. Do not use in patients who have had life-threatening hypersensitivity reactions to COAGADEX ( 4 ).. Always consult the full prescribing information and a clinician.