Indicated for treatment of bleeding episodes and perioperative management in adults and children with hemophilia A or B with inhibitors, congenital factor VII (FVII) deficiency, Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, and in adults with acquired hemophilia.
“There’s one patient I’ll never forget. When it was time to consider a joint replacement surgery, we knew where to turn for effective treatment.“1
Actor portrayal
“There’s one patient I’ll never forget. When it was time to consider a joint replacement surgery, we knew where to turn for effective treatment.“1
Actor portrayal
The experience continues
NovoSeven® RT has 35+ years of research and long-term clinical experience; 1,106 patients and 5,305 bleeds treated in registrational studies and ~400 successful surgeries and procedures.1‑26,a‑b
Effective control of the mildest to most life-threatening bleeds
Proven effective for treatment of bleeding episodes and perioperative management across 5 indications—more indications than any other bypassing agent.1,27-29
NovoSeven® RT is the only rFVIIa indicated for CHwI patients of all ages.1,28
Able to quickly treat bleeds when they occur
Rapid administration and infusion, leading to rapid activity.1,32,d
Clinical experience with Hemlibra®
NovoSeven® RT was the only recombinant factor used for breakthrough bleeds in patients with inhibitors in the Hemlibra® pivotal clinical trials.30,c
MASAC recommends rFVIIa to treat acute bleeds in patients with congenital hemophilia A with inhibitors taking emicizumab prophylaxis.31
#1 prescribed rFVIIa in hospitals2,e
NovoSeven® RT is the only rFVIIa approved for surgery and for use in patients of all ages.1,28,f
a1988: compassionate use initiated in the United States; 1999: FDA approval received for CHwI.1,26
bIncludes bleeding episodes, major and minor surgical procedures, traumatic injuries, and prophylaxis regimens. Success was defined differently in each study.
cThe analysis included bleeding episodes in the HAVEN1, HAVEN2, and HAVEN4 clinical trials for which patients with CHAwI on emicizumab prophylaxis (at the labeled dose) used rFVIIa. Initial individual dosing with rFVIIa, dosing intervals, and cumulative dosing were evaluated. All AEs reported in each of the 3 trials, including available narratives, were assessed. The cutoff dates for data presented were for HAVEN1 (primary analysis) September 2017; HAVEN2 (interim analysis) October 2017; and HAVEN4 (primary analysis) December 2017.30
dAdminister as a slow bolus injection over 2 to 5 minutes, depending on the dose administered.
eBased on Acumetis data collected Q1 2025 to Q1 2026.2
fUse in acquired hemophilia is indicated for adults only.
AE=adverse event; CHAwI=congenital hemophilia A with inhibitors; CHwI=congenital hemophilia with inhibitors; MASAC=Medical and Scientific Advisory Council; rFVIIa=recombinant activated Factor VII.
A well-established safety profile
Low rate of thrombotic events based on clinical trials, registries, and postmarketing retrospective safety assessment.1
- Serious arterial and venous thrombotic events have been reported in clinical trials and postmarketing surveillance.
- 0.2% of bleeding episodes in patients with CHwI
- 4% in patients with AH
- <0.2% of bleeding episodes in patients with GT with refractoriness to platelets
- 0.8% of bleeding episodes in patients with CFVIId1
- The most common and serious adverse reactions in clinical trials are thrombotic events1
Established safety profile for use with Hemlibra®30
Does not induce an anamnestic response1
- Contains only rFVIIa and does not contain any FVIII or FIX—unlike pd-aPCC1,27
Works at the site of vascular injury1,33
Associated with significant decreases in inhibitor titers in patients with high-responder inhibitors when used as the only bypassing agent34,g
gData from an analysis of exploratory observational findings in patients with hemophilia A and B with inhibitors (N=53) who were categorized as low responders or high responders. Patients were given either NovoSeven® RT or “other factor concentrates,” such as FVIII or prothrombin complex concentrates.34
AH=acquired hemophilia; CFVIId=congenital Factor VII deficiency; FIX=Factor IX; FVIII=Factor VIII; GT=Glanzmann’s thrombasthenia; pd-aPCC=plasma-derived activated prothrombin complex concentrate.
NovoSeven® RT effectively controls joint bleeds in CHwI—fast33
Median 2 doses
A median of 2 doses helped control joint bleeds in as little as 5 hours35,h
Maximum activity
NovoSeven® RT achieved maximum activity within 5-10 minutes of infusion32,i,j
Quick readministration, less volume
NovoSeven® RT can be readministered every 2 hours, compared to 6 to 12 hours for FEIBA®, and requires 16x less infusion volume for a joint bleed in a 70-kg patient1,27,k
hData from a randomized, double-blind, parallel-group, multicenter study of patients with hemophilia A or B with or without an inhibitor. Patients were given NovoSeven® RT at dosing intervals of 2 to 3 hours. Efficacy reflects the number of patients reporting excellent, effective, or partially effective results. Response was rated as “excellent” if a patient demonstrated definitive relief of pain/tenderness and/or if there was a measurable decrease in the size of the bleed (or arrest of bleeding) in 8 hours or less. An “effective” response was measured by any of these 3 events occurring from 8 to 14 hours; a “partially effective” response either occurred after 14 hours or indicated detectable relief of pain/tenderness or decrease in bleeding.35
iData from a randomized, double-blind trial of healthy subjects (N=22) who received 1 intravenous bolus injection each of NovoSeven® RT and NovoSeven®. Both bolus injections were 90 mcg/kg and occurred 2 to 3 weeks apart at consecutive visits. While the comparison is not shown for FVIIa, activity for NovoSeven® RT was the bioequivalent range of that for NovoSeven® during this period.32
jFVIIa activity IU/mL.32
k6.3-mL single infused dose of 90 mcg/kg of NovoSeven® RT vs 105-mL single infused dose of 75 U/kg of FEIBA®.1,27
FVIIa=activated Factor VII.
NovoSeven® RT helps a broad range of patients with the treatment of bleeding episodes and perioperative management1
This chart is not intended to compare efficacy or safety.
= bleed treatment
= perioperative management
= routine prophylaxis
= pediatric indication
lFor patients aged 12 years and older.28
mObizur® is contraindicated in patients with congenital hemophilia A with inhibitors.29
Learn more about how NovoSeven® RT helps your patients with:
Congenital Hemophilia A or B With Inhibitors
Acquired Hemophilia
Congenital Factor VII Deficiency
Glanzmann’s Thrombasthenia With Refractoriness to Platelet Transfusions
Patients can use MixPro® to reconstitute NovoSeven® RT
NovoSeven® RT mechanism of action
Help your patients learn about rare bleeding disorders
Important Safety Information for NovoSeven® RT
WARNING: THROMBOSIS
- Serious arterial and venous thrombotic events following administration of NovoSeven® RT have been reported
- Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven® RT
- Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis
Warnings and Precautions
- Serious arterial and venous thrombotic events have been reported in clinical trials and postmarketing surveillance
- Patients with congenital hemophilia receiving concomitant treatment with aPCCs (activated prothrombin complex concentrates), older patients particularly with acquired hemophilia and receiving other hemostatic agents, and patients with a history of cardiac and vascular disease may have an increased risk of developing thrombotic events
- Hypersensitivity reactions, including anaphylaxis, can occur with NovoSeven® RT. Patients with a known hypersensitivity to mouse, hamster, or bovine proteins may be at a higher risk of hypersensitivity reactions. Discontinue infusion and administer appropriate treatment when hypersensitivity reactions occur
- Factor VII deficient patients should be monitored for prothrombin time (PT) and factor VII coagulant activity (FVII:C). If FVII:C fails to reach the expected level, or PT is not corrected, or bleeding is not controlled after treatment with the recommended doses, antibody formation may be suspected and analysis for antibodies should be performed
- Laboratory coagulation parameters (PT/INR, aPTT, FVII:C) have shown no direct correlation to achieving hemostasis
Adverse Reactions
- The most common and serious adverse reactions in clinical trials are thrombotic events. Thrombotic adverse reactions following the administration of NovoSeven® RT in clinical trials occurred in 4% of patients with acquired hemophilia and 0.2% of bleeding episodes in patients with congenital hemophilia
Drug Interactions
- Thrombosis may occur if NovoSeven® RT is administered concomitantly with Coagulation Factor XIII
Please click here for NovoSeven® RT Prescribing Information, including Boxed Warning.
Indications and Usage
NovoSeven® RT (coagulation Factor VIIa, recombinant) is a coagulation factor indicated for:
- Treatment of bleeding episodes and perioperative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets
- Treatment of bleeding episodes and perioperative management in adults with acquired hemophilia
Important Safety Information for NovoSeven® RT
WARNING: THROMBOSIS
- Serious arterial and venous thrombotic events following administration of NovoSeven® RT have been reported
- Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven® RT
- Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis
Important Safety Information for NovoSeven® RT
WARNING: THROMBOSIS
- Serious arterial and venous thrombotic events following administration of NovoSeven® RT have been reported
- Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven® RT
- Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis
Warnings and Precautions
- Serious arterial and venous thrombotic events have been reported in clinical trials and postmarketing surveillance
- Patients with congenital hemophilia receiving concomitant treatment with aPCCs (activated prothrombin complex concentrates), older patients particularly with acquired hemophilia and receiving other hemostatic agents, and patients with a history of cardiac and vascular disease may have an increased risk of developing thrombotic events
- Hypersensitivity reactions, including anaphylaxis, can occur with NovoSeven® RT. Patients with a known hypersensitivity to mouse, hamster, or bovine proteins may be at a higher risk of hypersensitivity reactions. Discontinue infusion and administer appropriate treatment when hypersensitivity reactions occur
- Factor VII deficient patients should be monitored for prothrombin time (PT) and factor VII coagulant activity (FVII:C). If FVII:C fails to reach the expected level, or PT is not corrected, or bleeding is not controlled after treatment with the recommended doses, antibody formation may be suspected and analysis for antibodies should be performed
- Laboratory coagulation parameters (PT/INR, aPTT, FVII:C) have shown no direct correlation to achieving hemostasis
Adverse Reactions
- The most common and serious adverse reactions in clinical trials are thrombotic events. Thrombotic adverse reactions following the administration of NovoSeven® RT in clinical trials occurred in 4% of patients with acquired hemophilia and 0.2% of bleeding episodes in patients with congenital hemophilia
Drug Interactions
- Thrombosis may occur if NovoSeven® RT is administered concomitantly with Coagulation Factor XIII
Please click here for NovoSeven® RT Prescribing Information, including Boxed Warning.
Indications and Usage
NovoSeven® RT (coagulation Factor VIIa, recombinant) is a coagulation factor indicated for:
- Treatment of bleeding episodes and perioperative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets
- Treatment of bleeding episodes and perioperative management in adults with acquired hemophilia
References
- NovoSeven RT [package insert]. Plainsboro, NJ; Novo Nordisk Inc.
- Data on file. Novo Nordisk Inc; Plainsboro, NJ.
- Shapiro AD, Neufeld EJ, Blanchette V, Salaj P, Gut RZ, Cooper DL. Safety of recombinant activated factor VII (rFVIIa) in patients with congenital haemophilia with inhibitors: overall rFVIIa exposure and intervals following high (>240 μg kg⁻¹) rFVIIa doses across clinical trials and registries. Haemophilia. 2014;20(1):e23-e31.
- Shapiro AD, Gilchrist GS, Hoots WK, Cooper HA, Gastineau DA. Prospective, randomised trial of two doses of rFVIIa (NovoSeven) in haemophilia patients with inhibitors undergoing surgery. Thromb Haemost. 1998;80(5):773-778.
- Parameswaran R, Shapiro AD, Gill JC, Kessler CM; HTRS Registry Investigators. Dose effect and efficacy of rFVIIa in the treatment of haemophilia patients with inhibitors: analysis from the Hemophilia and Thrombosis Research Society Registry. Haemophilia. 2005;11(2):100-106.
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- Banov L, Pavanello M, Piattelli G, et al. Successful urgent neurosurgery management with rFVIIa mega doses in a child with haemophilia A and high titre inhibitor. Blood Coagul Fibrinolysis. 2014;25(5):518-521.
- de Souza DG, Waldron PE, Peeler BB, Baum VC. The use of activated factor VII for ventricular septal defect closure in a pediatric patient with hemophilia A and a high titer of inhibitor. J Cardiothorac Vasc Anesth. 2009;23(5):679-681.
- Aouba A, Dezamis E, Sermet A, et al. Uncomplicated neurosurgical resection of a malignant glioneuronal tumour under haemostatic cover of rFVIIa in a severe haemophilia patient with a high-titre inhibitor: a case report and literature review of rFVIIa use in major surgeries. Haemophilia. 2010;16(1):54-60.
- Goudemand J, Tagariello G, Lopaciuk F. Cases of surgery in high-responder haemophilia patients. Haemophilia. 2004;10(suppl 2):46-49.
- Watts RG. Successful use of recombinant factor VIIa for emergency fasciotomy in a patient with hemophilia A and high-titer inhibitor unresponsive to factor VIII inhibitor bypassing activity. Am J Haematol. 2005;79(1):58-60.
- Rajic N, Savic A, Popovic S, Urosevic I, Savic I. Successful control of bleeding during supracondylar amputation caused by severe compartment syndrome in patient with haemophilia A and high titre of inhibitor. Haemophilia. 2009;15(2):601-602.
- Mehta S, Nelson CL, Konkle BA, Vannozzi B. Total knee arthroplasty using recombinant factor VII in hemophilia-A patients with inhibitors: a report of three cases. J Bone Joint Surg Am. 2004;86(11):2519-2521.
- Pruthi RK, Mathew P, Valentino LA, et al; NovoSeven in Surgery Study Investigators. Haemostatic efficacy and safety of bolus and continuous infusion of recombinant factor VIIa are comparable in haemophilia patients with inhibitors undergoing major surgery. Thromb Haemost. 2007;98(4):726-732.
- Hedner U. History of rFVIIa therapy. Thromb Res. 2010;125(suppl 1):s4-s6.
- FEIBA. Package insert. Takeda Pharmaceuticals U.S.A., Inc; 2024.
- SEVENFACT. Package insert. HEMA Biologics; 2025.
- Obizur. Package insert. Takeda Pharmaceuticals U.S.A., Inc; 2024.
- Levy GG, Asikanius E, Kuebler P, Benchikh El Fegoun S, Esbjerg S, Seremetis S. Safety analysis of rFVIIa with emicizumab dosing in congenital hemophilia A with inhibitors: experience from the HAVEN clinical program. J Thromb Haemost. 2019;17(9):1470-1477.
- National Hemophilia Foundation. Recommendation on the use and management of emicizumab-kxwh (Hemlibra®) for hemophilia A with and without inhibitors (MASAC Document #268). April 27, 2022. Accessed October 21, 2025. https://www.bleeding.org/sites/default/files/document/files/268_Emicizumab.pdf
- Bysted BV, Scharling B, Møller T, Hansen BL. A randomized, double-blind trial demonstrating bioequivalence of the current recombinant activated factor VII formulation and a new robust 25°C stable formulation. Haemophilia. 2007;13(5):527-532.
- Hoffman M, Monroe DM III. The action of high-dose factor VIIa (FVIIa) in a cell-based model of hemostasis. Semin Hematol. 2001;38(4 suppl 12):6-9.
- Johannessen M, Andreasen RB, Nordfang O. Decline of factor VIII and factor IX inhibitors during long-term treatment with NovoSeven®. Blood Coagul Fibrinolysis. 2000;11(3):239-242.
- Lusher JM, Roberts HR, Davignon G, et al; rFVIIa Study Group. A randomized, double-blind comparison of two dosage levels of recombinant factor VIIa in the treatment of joint, muscle and mucocutaneous haemorrhages in persons with haemophilia A and B, with and without inhibitors. Haemophilia. 1998;4(6):790-798.