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.
“When he became more active, we knew where to turn for a fast home treatment for his breakthrough bleeds.”1
Having an on-demand agent on hand helps keep patients prepared to act quickly.2
For CHAwI or CHBwI.
CHAwI=congenital hemophilia A with inhibitors; CHBwI=congenital hemophilia B with inhibitors.
Acute bleeds require urgent action3
19-year-old male (160 lb, 73 kg) with CHAwI on prophylactic emicizumab (219 mg every 2 weeks). Patient reported some pain and swelling in his left knee after a mild fall while playing soccer. He asked if treatment is needed.
What is your next move?
Do you monitor with conditional intervention
(balance managing symptoms)?
Patient was told to monitor symptoms, focusing on intensity of pain, swelling, and mobility
Advised to follow rest, ice, compression, and elevation (RICE) to minimize initial swelling and discomfort
Informed to contact you or seek care if there is increased or severe pain, worsening swelling in the joint, or reduced joint mobility
Next day, patient noticed increased swelling in left knee and called HCP, who advised treating at the ED
In the ED, patient was administered NovoSeven® RT (90 mcg/kg) followed by 2 additional doses at 2-hour intervals (total dose of 19,710 mcg of NovoSeven® RT)
OUTCOME: Bleed resolved after a total of 3 infusions of NovoSeven® RT. Pain and swelling post treatment improved over the next 3 days
Or do you treat urgently
(treat proactively before bleed worsens)?
Patient was told to treat the bleed proactively and to call if symptoms do not resolve
The patient self-administered a 6,570 mcg dose of NovoSeven® RT (90 mcg/kg) at home within 2 hours of the bleed
OUTCOME: Bleeding and symptoms resolved with 1 dose of NovoSeven® RT on the same day
Case study for illustrative purposes. Individual results may vary.
ED=emergency department; HCP=health care professional.
NovoSeven® RT—a first choice for treating breakthrough bleeding for patients with CHAwI on emicizumab4
MASAC recommends rFVIIa to treat acute bleeds in patients with congenital hemophilia A with inhibitors taking emicizumab prophylaxis4
- Use of FEIBA® (anti-inhibitor coagulant complex) with emicizumab should be avoided if possible, as it may cause thrombosis or TMA5
WFH recommends rFVIIa for patients with HBwI with a history of anaphylaxis to FIX-containing clotting factor concentrates3
- FEIBA® should not be used, as it contains FIX and may cause or worsen an allergic reaction5
FIX=Factor IX; HBwI=hemophilia B with inhibitors; MASAC=Medical and Scientific Advisory Council; rFVIIa=recombinant activated Factor VII; TMA=thrombotic microangiopathy; WFH=World Federation of Hemophilia.
NovoSeven® RT was the only rFVIIa that was used for breakthrough bleeds in patients with inhibitors in the Hemlibra® pivotal clinical trials6,a
During the HAVEN studies, in patients receiving emicizumab prophylaxis:
- 47% of bleeds were treated with a single injection of NovoSeven® RT in HAVEN6,a
- 2 cases of TMA occurred in patients receiving FEIBA® and NovoSeven® RT. Simultaneous use of Hemlibra® and FEIBA® should be avoided6
- SEVENFACT® was not used in the emicizumab pivotal clinical trials6
No new or unexpected safety concerns related to concomitant use of NovoSeven® RT and emicizumab were identified in the HAVEN1, HAVEN2, and HAVEN4 clinical trials6,a
- Serious arterial and venous thrombotic events have been reported in clinical trials and postmarketing surveillance
Justin lives with
hemophilia A
with inhibitors.
aThe 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 2017.6
AE=adverse event.
Real-world results reinforce that NovoSeven® RT should be administered early7
Congenital hemophilia A and B with inhibitors trial data showed NovoSeven® RT to be 93% effective at resolving bleeds.7,b
Proven trial results in CHAwI and CHBwI7,b
Efficacy seen in adept™2
93% effective
All assessed bleed locations at 12 hours (N=69)
The post hoc analysis of real-world results aligns with NovoSeven® RT clinical trial results for hemophilia patients with inhibitors experiencing mild-to-moderate bleeding episodes7,8,b,c
In the post hoc analysis of SMART‑7™, a large, prospective, postmarketing study of patients with CHwI, early treatment (≤1 hr) with NovoSeven® RT effectively resolved bleeds8,c
All bleeds:
(N=318)
Joint bleeds:
(N=186)
Muscle bleeds:
(N=74)
bData from an international, multicenter, randomized, double-blind, active-controlled, confirmatory phase 3 trial of patients with hemophilia A with inhibitors (n = 66) or hemophilia B with inhibitors (n = 6). Primarily carried out in the home setting, all bleeds were treated, and each bleeding episode was randomized (3:2) to infuse either 1 to 3 doses of vatreptacog alfa (340 bleeding episodes; 80 mcg/kg) or 1 to 3 doses of NovoSeven® RT (227 bleeding episodes; 90 mcg/kg) when bleed symptoms were recognized, preferably within 2 hours of onset. The primary efficacy endpoint was effective bleed control defined as no additional hemostatic treatment (other than the original medication) given within 12 hours after the initial dose.7
cSMART-7™ was a prospective, observational, single-arm, open-label study conducted over the course of 5 years (patients remained in the study for maximum 2 years or until 25 exposure days of on-demand rFVIIa), including 51 patients with CHAwI or CHBwI, that monitored decreased therapeutic response treated with the room temperature–stable formulation of rFVIIa and the development of neutralizing antibodies toward FVII. Patients evaluated the status of bleeding episodes after each treatment as “bleed stopped,” “bleed slowed,” or “no change/worsened.” Based on these evaluations, treatment was described as “effective,” “partially effective,” or “ineffective,” respectively. The post-hoc data set included 482 bleeding episodes reported by 45 patients treated with rFVIIa. Patients included in the post-hoc subgroup analysis required the hemostatic response to treatment with rFVIIa monotherapy, by time to first treatment and in different age cohorts was assessed for bleeds satisfying the following four criteria: (1) valid efficacy assessment, (2) no missing time for bleed start, (3) no missing time for any dose administration, and (4) valid time to first treatment. The small number of patients in each of the age cohorts assessed and the differences between the time-to-treatment subgroup sizes are limitations of the study that should be taken into account. It is also possible that the rFVIIa monotherapy group could have largely comprised patients with milder disease or bleeding, as these patients may be more likely to receive a single effective treatment compared with patients with more severe bleeding. In addition, the results need to be considered in light of the fact that this was a post hoc analysis.7
CHwI=congenital hemophilia with inhibitors; FVII=Factor VII.
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Teach patients to quickly identify the signs and symptoms of internal bleeds
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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.
- National Hemophilia Foundation. MASAC recommendation on administration of inhibitor bypassing agents in the home for patients with hemophilia and inhibitors (MASAC Document #274). September 8, 2022. Accessed July 31, 2026. https://www.hemophilia.org/sites/default/files/document/files/274_HomeAdministration.pdf
- Srivastava A, Santagostino E, Dougall A, et al. WFH guidelines for the management of hemophilia, 3rd edition. Haemophilia. 2020;26(suppl 6):1-158.
- 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
- FEIBA. 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.
- Lentz SR, Ehrenforth S, Abdul Karim FA, 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.
- Demartis F, Batorava A, Chambost H, et al. Real-world early treatment with room temperature-stable recombinant factor VIIa in hemophilia A/B and inhibitors: SMART-7™ post hoc analyses. TH Open. 2017;1(2):e130-e138.