Factor Viia

The active ingredient in SEVENFACT is a recombinant analog of human Factor VIIa, a vitamin K-dependent coagulation factor. In the presence of both calcium and phospholipids, Factor VIIa in a complex with tissue factor (TF) activates Factor X to Factor Xa, directly bypassing the reactions that require Factor VIII or Factor IX.

• SEVENFACT is indicated for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors. Limitation s of Use: SEVENFACT is not indicated for the treatment of patients with congenital Factor VII deficiency.

• SEVENFACT is contraindicated in patients with: known allergy to rabbits or rabbit proteins. Exposure to SEVENFACT in these patients can result in severe hypersensitivity reaction.contraindicated

For i ntravenous u se after reconstitution only . Type of Bleeding Dosing Regimen Recommendation For Mild or Moderate bleeds 75 mcg/kg repeated every 3 hours until hemostasis is achieved or Initial dose of 225 mcg/kg. If hemostasis is not achieved within 9 hours, additional 75 mcg/kg doses may be administered every 3 hours as needed to achieve hemostasis For Severe bleeds 225 mcg/kg, followed if necessary 6 hours later with 75 mcg/kg every 2 hours Consider alternative treatments if successful control of bleeding does not occur within 24 hours of the first administration of SEVENFACT. The vial includes a rubber stopper under the plastic cap. The syringe plunger rod has a wide top end and threaded end. The pre-filled syringe with Water for Injection diluent has a plastic backstop, rubber stopper, syringe tip (luer lock top under syringe cap), and syringe cap. The SEVENFACT 1 mg and 2 mg vial adapter and SEVENFACT 5 mg vial adapter each contain a plastic cover, paper protective cover, and spike (under protective paper). 2.1 Dose For intravenous use after reconstitution only. Dose and duration of SEVENFACT depend on the location and severity of the bleeding, need for urgent hemostasis, frequency of administration, and known patient responsiveness to FVIIa-containing bypassing agents during prior bleeding events. Treatment with SEVENFACT should be initiated as soon as a bleeding event occurs. The dose, frequency, and duration of SEVENFACT therapy should be based on the patient’s clinical response and hemostasis evaluation.

Patients with hemophilia A or B with inhibitors who have other risk factors for thrombosis may be at increased risk of serious arterial and venous thrombotic events ( 5.1 ). Hypersensitivity reactions, including anaphylaxis, are possible with SEVENFACT. Should symptoms occur, patients should discontinue SEVENFACT and seek appropriate medical intervention ( 5.2 ). 5.1 Thrombosis Serious arterial and venous thrombosis can occur with coagulation factor VIIa containing products including SEVENFACT. The following patients may have increased risk of thrombosis with use of SEVENFACT: History of congenital or acquired hemophilia receiving concomitant treatment with aPCC/PCC (activated or non-activated prothrombin complex) or other hemostatic agents History of atherosclerotic disease, coronary artery disease, cerebrovascular disease, crush injury, septicemia, or thromboembolism. Monitor patients who receive SEVENFACT for the development of signs and symptoms of activation of the coagulation system or thrombosis. When there is laboratory confirmation of intravascular coagulation or presence of clinical thrombosis, reduce the dose of SEVENFACT or stop treatment, depending on the patient’s condition. 5.2 Hypersensitivity and Infusion-Related Reactions Hypersensitivity and infusion-related reactions including anaphylaxis can occur with coagulation factor VIIa containing products including SEVENFACT.

The most common adverse reactions (incidence ≥1%) were headache, dizziness, infusion-site discomfort, infusion-site hematoma, infusion-related reaction, and fever ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact HEMA Biologics at 855-718-HEMA (4362) or FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because 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 trials of another drug and may not reflect the rates observed in practice. The safety database described in this section reflect exposure to SEVENFACT in two clinical studies, Study 1 and Study 2. A total of 42 patients with Hemophilia A or B with or without inhibitors received SEVENFACT: 27 patients in Study 1 at doses 75 mcg/kg and 225 mcg/kg and 15 patients in Study 2 at three escalating dose levels 25 mcg/kg, 75 mcg/kg and 225 mcg/kg [see Clinical Studies ( 14 )] . The most common adverse reactions (incidence ≥1%) reported in clinical trials for SEVENFACT were headache, dizziness, infusion-site discomfort, infusion-site hematoma, infusion-related reaction, and fever. Adverse reactions reported in the two clinical studies are shown in Table 2.

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies using SEVENFACT in pregnant women to determine whether there is a drug-associated risk. Animal studies evaluating the embryo-fetal teratogenic potential of SEVENFACT have not been conducted. It is unknown whether SEVENFACT can cause fetal harm when administered to a pregnant woman or can affect fertility. In the U.S. general population, the estimated background risks of major birth defect and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. 8.2 Lactation Risk Summary There is no information regarding the presence of SEVENFACT in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SEVENFACT and any potential adverse effects on the breastfed infant from SEVENFACT or from the underlying maternal condition. 8.3 Females and Males of Reproductive Potential Risk Summary In Study 1, male patients cautioned to avoid sexual activity without condoms received SEVENFACT for the treatment of bleeding episodes. No pregnancies from sexual partners were reported. The relative benefits of SEVENFACT should be weighed against any potential risk arising from exposure in sexually active patients.

Metabolism

Pharmacokinetic (PK) evaluation was conducted in an open-label, randomized, dose-comparison study to evaluate safety and pharmacokinetic of SEVENFACT in 28 adult patients (ages 18-75 yrs) with hemophilia A with or without inhibitors who were not actively bleeding. Patients received a single intravenous administration of either 75 mcg/kg or 225 mcg/kg dose of SEVENFACT.

1. 1Drug Ineffective2633%
2. 2Off Label Use1823%
3. 3Haemorrhage78.9%
4. 4No Adverse Event67.6%
5. 5Anti Factor Viii Antibody Positive45.1%
6. 6Covid-1945.1%
7. 7Haemarthrosis45.1%
8. 8Therapy Non-responder45.1%
9. 9Activated Partial Thromboplastin Time Prolonged33.8%
10. 10Fall33.8%
11. 11Haematoma33.8%
12. 12Anti Factor Viii Antibody Increased22.5%
13. 13Device Related Thrombosis22.5%
14. 14Drug Effective For Unapproved Indication22.5%
15. 15Drug Ineffective For Unapproved Indication22.5%

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

• The effects of recombinant human activated factor VII and tranexamic acid on traumatic bleeding and mortality in mice.
  Research and practice in thrombosis and haemostasis · 2026 · Chumappumkal Joseph B, De Pablo-Moreno JA, Falah N, et al.
  PMID 42027309DOI 10.1016/j.rpth.2026.103436
• Management of traumatic hyphema in a patient with Glanzmann thrombasthenia using intraoperative recombinant factor VIIa.
  Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus · 2026 · Güleser ÜY, Usta Küçükbezirci G, Dogan C, et al.
  PMID 41796935DOI 10.1016/j.jaapos.2026.104789
• Recombinant factor VIIa versus placebo for spontaneous intracerebral haemorrhage within 2 h of symptom onset (FASTEST): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial.
  Lancet (London, England) · 2026 · Broderick JP, Naidech AM, Elm JJ, et al.
  PMID 41653933DOI 10.1016/S0140-6736(26)00097-8
• A first-in-human study assessing the safety, pharmacokinetics, and pharmacodynamics of TU7710, a recombinant factor VIIa-transferrin fusion protein, in warfarin-pretreated healthy male participants.
  Journal of thrombosis and haemostasis : JTH · 2026 · Kim B, Song J, Kang J, et al.
  PMID 41651288DOI 10.1016/j.jtha.2025.12.023
• Nonstandard Factor VIIa Binding Mode Reveals S1 Pocket Plasticity in Trypsin-Like Proteases.
  ChemMedChem · 2026 · Tesmer L, Matter H, Klingler O, et al.
  PMID 41619300DOI 10.1002/cmdc.202500846
• Real World Experience with use of Coagulation Factor VIIa at an Academic Medical Center.
  Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis · 2025 · George AR, Sylvester KW, Kanaan DM, et al.
  PMID 41379429DOI 10.1177/10760296251405425
• Use of recombinant activated factor VII to stop post-kidney biopsy bleeding in a child.
  Pediatric nephrology (Berlin, Germany) · 2026 · Park E, Kerkvliet SP, Hughes AD, et al.
  PMID 41329289DOI 10.1007/s00467-025-07063-y
• FVIIa-AT complexes in patients with acute ischemic stroke: Impact on clinical outcomes.
  Thrombosis research · 2026 · Kachnic M, Matysiewicz M, Natorska J, et al.
  PMID 41314113DOI 10.1016/j.thromres.2025.109551

The 10 most recently updated of 125 ClinicalTrials.gov registrations naming Factor Viia as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
  Active not recruiting · Observational · 44 enrolled · Hoffmann-La Roche
  NCT06883240updated 2026-06-12
• A Research Study to See How Safe is Eptacog Alfa When Used to Stop Heavy Bleeding in Women After Giving Birth in India
  Recruiting · Phase 4 · Interventional · 64 enrolled · Novo Nordisk A/S
  NCT07157423updated 2026-06-12
• Anti-αIIbβ3 Immunization in Glanzmann Thrombasthenia: Prevalence and Associated Risk Factors: Thrombasthenia Anti-αIIbβ3 Antibodies Study (TAAS)
  Completed · Interventional · 28 enrolled · University Hospital, Bordeaux
  NCT04595617updated 2026-05-22
• SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis
  Recruiting · Phase 3 · Interventional · 5 enrolled · Emory University
  NCT04563520updated 2026-04-29
• Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2
  Recruiting · Phase 3 · Interventional · 350 enrolled · Joseph Broderick, MD
  NCT07227246updated 2026-04-22
• Comparative Outcomes of PCC and Recombinant Activated Factor VIIa in Trauma-Associated Massive Transfusion
  Recruiting · Observational · 4 enrolled · Zeliha Alicikus
  NCT07290634updated 2026-04-14
• A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia
  Active not recruiting · Phase 3 · Interventional · 91 enrolled · Sanofi
  NCT05662319updated 2026-02-04
• Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial
  Active not recruiting · Phase 3 · Interventional · 860 enrolled · Joseph Broderick, MD
  NCT03496883updated 2026-01-21
• SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
  Recruiting · Phase 4 · Interventional · 55 enrolled · American Thrombosis and Hemostasis Network
  NCT04647227updated 2026-01-12
• Eptacog Beta in Glanzmann's (HeT_LFB-Strength-Study_FID531)
  Recruiting · Phase 2 · Interventional · 6 enrolled · Emory University
  NCT07136857updated 2025-12-01

Frequently asked questions

How does Factor Viia work?

The active ingredient in SEVENFACT is a recombinant analog of human Factor VIIa, a vitamin K-dependent coagulation factor. In the presence of both calcium and phospholipids, Factor VIIa in a complex with tissue factor (TF) activates Factor X to Factor Xa, directly bypassing the reactions that require Factor VIII or Factor IX.

What is Factor Viia used for?

According to FDA labeling, Factor Viia carries indications including: SEVENFACT is indicated for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors. Limitation s of Use: SEVENFACT is not indicated for the treatment of patients with congenital Factor VII deficiency.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Factor Viia?

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

What are the brand names for Factor Viia?

Factor Viia is marketed under brand names including Novoseven, Sevenfact.

What are the contraindications for Factor Viia?

Factor Viia labeling lists contraindications including: SEVENFACT is contraindicated in patients with: known allergy to rabbits or rabbit proteins. Exposure to SEVENFACT in these patients can result in severe hypersensitivity reaction.. Always consult the full prescribing information and a clinician.