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.
Actor portrayal
“I’ll never forget my first patient. When I saw a prolonged aPTT, I knew where to turn for a fast treatment.”1
aPTT=activated partial thromboplastin time.
Count on NovoSeven® RT for your hospital
Proven effective for treatment of bleeding episodes and perioperative management across 5 indications—more than any other bypassing agent2-5
The first and only FDA-approved bypassing agent for acquired hemophilia2
The only rFVIIa approved for surgery in children and adults2 used in ~400 successful surgeries and procedures6-27,b,c
bSuccess was defined differently in each study.
cUse in acquired hemophilia is indicated for adults only.
rFVIIa=recombinant activated Factor VII.
Congenital hemophilia with inhibitors, as seen in the adept™2 clinical trial28
Acquired hemophilia29 (first‑line treatment)
Congenital Factor VII deficiency2,30
Glanzmann’s thrombasthenia with refractoriness to platelet transfusions2
NovoSeven® RT for your hospital: the broadest range of protection2-5,d
This chart is not intended to compare efficacy or safety.
CHAwI
CHBwI
Acquired
hemophilia
GT with refractoriness
to platelet
transfusions
CFVIId
NovoSeven®RT2
(coagulation Factor VIIa, recombinant)
SEVENFACT®3
[coagulation factor VIIa (recombinant)-jncw]
FEIBA®4
[anti-inhibitor coagulant complex]
Obizur®5
[antihemophilic factor (recombinant), porcine sequence]
= bleed treatment;
= perioperative management
= routine prophylaxis
= pediatric indication
dIndicated for bleed control and surgery in 5 bleeding disorders.2
eFor patients aged 12 years and older.3
fObizur® is contraindicated in patients with congenital hemophilia A with inhibitors.5
CFVIId=congenital Factor VII deficiency; CHAwI=congenital hemophilia A with inhibitors; CHBwI=congenital hemophilia B with inhibitors; GT=Glanzmann’s thrombasthenia.
Patients with severe bleeds taking NovoSeven® RT require
less volume for their initial dose2-5,g
NovoSeven® RT requires fewer vials per dose vs FEIBA®2,4,g
- The low-volume dosing of NovoSeven® RT means less space used when storing product
NovoSeven® RT has 16x lower infusion volume and is up to 3x faster to infuse compared with FEIBA®2,4,g
- 2 to 5 minutes to infuse with NovoSeven® RT vs 7.5 minutes with FEIBA®2,4,h
For acquired hemophilia, NovoSeven® RT has 4x lower infusion volume and can be infused up to 7x faster compared with Obizur®2,5,g
- NovoSeven® RT requires 6.3 mL and takes 2 to 5 minutes to infuse vs 28 mL and 14 to 28 minutes to infuse with Obizur®2,5
gInfusion volume comparison based on initial dose for a severe joint bleed for a patient weighing 88 kg (194 lb). For NovoSeven® RT, the initial dose of 90 mcg/kg requires an infusion volume of 8 mL; for FEIBA®, the initial dose of 75 U/kg requires an infusion volume of 132 mL; for SEVENFACT®, the initial dose of 225 mcg/kg requires an infusion volume of 20 mL; for Obizur®, the initial dose of 200 U/kg requires an infusion volume of 35 mL.2-5
hPatients are cautioned that the maximum injection or infusion rate must not exceed 10 units per kg of body weight per minute.
NovoSeven® RT offers
features to support hospital use2
- Faster to infuse compared with FEIBA® and Obizur®2,4,5,i
- NovoSeven® RT has one dosing regimen for patients with CHwI regardless of bleed severity. That consistent dosing may lead to predictable utilization2
- Ability to administer via continuous infusion for perioperative management for major surgeries in patients with CHwI2
- Low rate of thrombotic adverse events based on clinical trials and registry data2
- Serious arterial and venous thrombotic events have been reported in clinical trials and postmarketing surveillance. Thrombotic adverse reactions in pivotal clinical trials occurred in 0.2% of bleeding episodes in CHwI, 4% in AH, 0.8% in CFVIId, and <0.2% in GT with refractoriness to platelet transfusions2
iAdminister NovoSeven® RT as a slow bolus injection over 2 to 5 minutes, depending on the dose administered.1 FEIBA® should be injected or infused intravenously at a rate that does not exceed 10 units per kg of body weight per minute. For a dose of 75 U/kg, this equates to an infusion time of 7.5 minutes per kg of body weight. Administer Obizur® intravenously at a rate of 1 to 2 mL per minute. For a 75-kg patient receiving a dose of 200 U/kg, this corresponds to an infusion time of 15 to 30 minutes.2,4,5
AH=acquired hemophilia; CHwI=congenital hemophilia with inhibitors.
- Low-volume dosing and compact packaging to help maximize space2
- Room temperature storage up to 77 °F2,l
- Histidine diluent provided in either a vial or prefilled diluent syringe2
- Available in 1-mg, 2-mg, 5-mg, and 8-mg vials with everything needed for reconstitution in 1 box2
lPrior to reconstitution, store NovoSeven® RT powder and histidine diluent between 36-77 °F. After reconstitution, store NovoSeven® RT either at room temperature or refrigerated for up to 3 hours. Do not freeze reconstituted NovoSeven® RT or store in syringes.2
- For situations where patients have inhibitors, MASAC recommends that care should be urgently discussed with the patient's hematologist. If in a life- or limb-threatening scenario, the safest immediate action is to prescribe rFVIIa at a dose of 90 mcg/kg or FEIBA at 75-100 units/kg.31
- MASAC also recommends rFVIIa as a first option to treat acute bleeding episodes in patients with CHAwI on emicizumab—FEIBA® should be avoided if possible32
- For patients with CHAwI on emicizumab, duration of FEIBA® therapy should be minimized. Prolonged usage of FEIBA® for >24 hours with doses above 100 units/kg/day may be associated with thrombosis and TMA32
ER=emergency room; MASAC=Medical and Scientific Advisory Council; TMA=thrombotic microangiopathy.
Explore clinical pathways for CHwI & acquired hemophilia
Actor portrayal
Is your hospital ready to treat emergent bleeds for CHwI patients?
A severe bleed doesn’t just mean danger today—delayed treatment of emergent bleeds in the CHwI population may result in cumulative damage.33
Take steps to see if your emergency department is prepared to stop bleeds quickly.
Explore the emergent bleeds clinical pathway
Actor portrayals
Early diagnosis is crucial for treating acquired hemophilia—do you know the signs?
Acquired hemophilia (AH) is a rare and often idiopathic autoimmune condition that can cause severe and even fatal bleeding in a variety of patients.34
It's time to equip every department with resources and information to rapidly diagnose and treat AH.
Explore the AH clinical pathway
Study design
adept™2 phase 3 trial
Patients randomized: Patients ≥12 years of age with hemophilia A with inhibitors (N=66) or hemophilia B with inhibitors (N=6) who have experienced at least 5 bleeds during treatment prior to entering the trial.
Study design: A 12-month, international, multicenter, randomized, double-blind, active-controlled, crossover, confirmatory phase 3 trial. Primarily done in the home setting, treatment of bleeding episodes were randomized, either treated with 1 to 3 doses of vatreptacog alfa (340 bleeding episodes) at 80 mcg/kg or 1 to 3 doses of NovoSeven® RT (227 bleeding episodes) at 90 mcg/kg.
Primary endpoint: Effective bleed control, which was defined as no additional treatment needed (other than the original medication) within 12 hours after first dose.
Secondary endpoint: Effective and sustained bleed control at 1 and 2 days after initial dose, number of doses of trial product for each bleed, and changes in pain assessment.
Compassionate use programs, the Hemostasis and Thrombosis Research Society (HTRS) Registry, and independent published reports
Patients considered: Patients diagnosed with acquired hemophilia from compassionate and emergency use programs (N=61), the HTRS Registry (N=9), and independent published reports (N=69).
Study design: Data were extracted from a review of experiences with recombinant FVIIa for the treatment of acquired hemophilia in compassionate and emergency use programs, the HTRS Registry, and independent published reports. Efficacy was evaluated similarly but not identically between compassionate use programs, the HTRS Registry, and published reports.
Efficacy of NovoSeven® RT is based on pooled data from the NovoSeven® RT compassionate and emergency use programs (1988-1999), the HTRS Registry, and independent published reports from January 1999 to September 2005. The analysis includes 182 bleeding episodes in 139 patients; NovoSeven® RT was used as first-line and salvage therapy in 103 and 73 episodes, respectively. The percentage of effectiveness noted includes episodes that were evaluated as effective or partially effective.
Patients considered: Data were collected from published literature, compassionate use trials, and the HTRS Registry for patients with congenital factor VII deficiency (N=70) treated with NovoSeven® RT.
Study design: NovoSeven® RT was used as treatment in 124 bleeding episodes, surgeries, or prophylaxis regimens. Dosing ranged from 6 to 98 mcg/kg administered every 2 to 12 hours (except for prophylaxis [doses administered from 2 times per day up to 2 times per week]). Patients were treated with an average of 1 to 10 doses. Treatment was effective if bleeding stopped or the physician rated the treatment as effective.
Patients considered: Data were collected from the GTR in patients with Glanzmann’s thrombasthenia (N=218).
Study design: Adjudicator-assessed effectiveness of treatment regimens in patients with GT (N=218) in all severe bleeding episodes and all surgical procedures (N=1073) based on review of Glanzmann’s Thrombasthenia Registry (GTR) data unblinded to investigator-coded efficacy. Efficacy was evaluated on a 2-point scale (clinical assessment of success or failure of treatment regimen as a whole, blinded and unblinded to investigator-coded outcome) including 92 patients treated with NovoSeven® RT for 266 bleeding episodes and 77 patients treated for 160 surgical procedures.
Explore interactive dosing tools
Need administration information?
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
- Data on file. Novo Nordisk Inc; Plainsboro, NJ.
- NovoSeven RT [package insert]. Plainsboro, NJ; Novo Nordisk Inc.
- SEVENFACT. Package insert. HEMA Biologics; 2025.
- FEIBA. Package insert. Takeda Pharmaceuticals U.S.A., Inc; 2024.
- Obizur. Package insert. Takeda Pharmaceuticals U.S.A., Inc; 2024.
- 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.
- Ingerslev J, Friedman D, Gastineau D, et al. Major surgery in haemophilic patients with inhibitors using recombinant factor VIIa. Haemostasis. 1996;26(suppl 1):118-123.
- Rodriguez-Merchan EC, Wiedel JD, Wallny T, et al. Elective orthopedic surgery for hemophilia patients with inhibitors: new opportunities. Semin Hematol. 2004;41(1 suppl 1):109-116.
- Giangrande PLF, Wilde JT, Madan B, et al. Consensus protocol for the use of recombinant activated factor VII [eptacog alfa (activated); NovoSeven®] in elective orthopaedic surgery in haemophilic patients with inhibitors. Haemophilia. 2009;15(2):501-508.
- Takedani H, Kawahara H, Kajiwara M. Major orthopaedic surgeries for haemophilia with inhibitors using rFVIIa. Haemophilia. 2010;16(2):290-295.
- Boadas A, Férnandez-Palazzi F, De Bosch NB, Cedeño M, Ruiz-Sáez A. Elective surgery in patients with congenital coagulopathies and inhibitors: experience of the National Haemophilia Centre of Venezuela. Haemophilia. 2011;17(3):422-427.
- Polyanskaya T, Zorenko V, Karpov E, Sampiev M, Mishin G, Vasiliev D. Experience of recombinant activated factor VII usage during surgery in patients with haemophilia with inhibitors. Haemophilia. 2012;18(6):997-1002.
- Takedani H, Shima M, Horikoshi Y, et al. Ten-year experience of recombinant activated factor VII use in surgical patients with congenital haemophilia with inhibitors or acquired haemophilia in Japan. Haemophilia. 2015;21(3):374-379.
- Balkan C, Karapinar D, Aydogdu S, et al. Surgery in patients with haemophilia and high responding inhibitors: Izmir experience. Haemophilia. 2010;16(6):902-909.
- Salaj P, Gurlich R, Svorcová V, Marková M, Cetkovský P. Prophylactic preparation and surgical extirpation of a very large abdominal blood cyst in a severe haemophilia A patient with inhibitors managed by rFVIIa. Haemophilia. 2009;15(1):380-382.
- Valentino LA, Cooper DL, Goldstein B. Surgical experience with rFVIIa (NovoSeven) in congenital haemophilia A and B patients with inhibitors to factors VIII or IX. Haemophilia. 2011;17(4):579-589.
- 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.
- Rodriguez-Merchan EC, Jimenez-Yuste V, Gomez-Cardero P, Alvarez-Roman M, Martin-Salces M, Rodriguez de la Rua A. Surgery in haemophilia patients with inhibitors, with special emphasis on orthopaedics: Madrid experience. Haemophilia. 2010;16(102):84-88.
- Caviglia H, Candela M, Galatro G, Neme D, Moretti N, Bianco RP. Elective orthopaedic surgery for haemophilia patients with inhibitors: single centre experience of 40 procedures and review of the literature. Haemophilia. 2011;17(6):910-919.
- 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 Hematol. 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. 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.
- Lentz SR, Ehrenforth S, Abdul Karim F, et al; adept™2 investigators. Recombinant factor VIIa analog in the management of hemophilia with inhibitors: results from a multicenter, randomized, controlled trial of vatreptacog alfa. J Thromb Haemost. 2014;12(8):1244-1253.
- Sumner MJ, Geldziler BD, Pedersen M, Seremetis S. Treatment of acquired haemophilia with recombinant activated FVII: a critical appraisal. Haemophilia. 2007;13(5):451-461.
- Mariani G, Napolitano M, Dolce A, et al. Replacement therapy for bleeding episodes in factor VII deficiency: a prospective evaluation. Thromb Haemost. 2013;109(2):238-247.
- National Hemophilia Foundation. MASAC guidelines for emergency department management of individuals with hemophilia and other bleeding disorders (MASAC Document #257). December 5, 2019. Accessed July 8, 2026. https://www.bleeding.org/sites/default/files/document/files/257.pdf
- 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
- Salek SZ, Benson GM, Elezovic I, et al. The need for speed in the management of haemophilia patients with inhibitors. Haemophilia. 2011;17(1):95-102.
- Huth-Kühne A, Baudo F, Collins P, et al. International recommendations on the diagnosis and treatment of patients with acquired hemophilia A. Haematologica. 2020;94(4):566-575.