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.
Acute bleeds require urgent action1:
Help patients beat breakthrough bleeds2
"When he became more active, we knew where to turn for a fast home treatment for his breakthrough bleeds.”3
Having an on-demand agent on hand helps keep patients prepared to act quickly.
For CHAwI or CHBwI.
Actor portrayal.
NovoSeven® RT is a first choice for treating breakthrough bleeding for hemophilia A with inhibitors (CHAwI) patients on emicizumab.2
MASAC recommends rFVIIa to treat acute bleeds in patients with congenital hemophilia A with inhibitors taking emicizumab prophylaxis2
Use of FEIBA® (anti-inhibitor coagulant complex) for breakthrough bleed treatment for patients on emicizumab should be avoided if possible, and rFVIIa should be the first option used to treat acute bleeding events as the use in combination with emicizumab does not alter the rFVIIa safety profile.2
Duration of FEIBA® therapy should also be minimized, as prolonged use for >24 hours with doses above 100 IU/kg/day may be associated with thrombosis and TMA.2
Justin lives with hemophilia A with inhibitors
Justin lives with hemophilia A with inhibitors
NovoSeven® RT was the only recombinant factor used for breakthrough bleeds in patients with inhibitors in the Hemlibra® pivotal clinical trials4,a
During the HAVEN studies, in patients receiving Hemlibra® prophylaxis for breakthrough bleeds in pivotal clinical trials4:
• 180 bleeds were treated with NovoSeven® RT only in HAVEN14,a
• No serious AEs and no cases of TMA or TE demonstrated in 3 pivotal trials with use of NovoSeven® RT alone4,a
• Two cases of TMA occurred in patients receiving FEIBA® and NovoSeven® RT. Simultaneous use of NovoSeven® RT and FEIBA® should be avoided5
No new or unexpected safety concerns related to concomitant use of NovoSeven® RT and emicizumab were identified in the HAVEN1, HAVEN2, and HAVEN4 clinical trials4,a
Justin lives with hemophilia A with inhibitors
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 cut-off dates for data presented were for HAVEN1 (primary analysis) September 2017; HAVEN2 (interim analysis) October 2017; and HAVEN4 (primary analysis) December 2017.4
AE=adverse event; CHAwI=congenital hemophilia A with inhibitors; CHBwI=congenital hemophilia B with inhibitors; rFVIIa=recombinant factor VIIa; TE=thrombotic event; TMA=thrombotic microangiopathy.
Real-world results reinforce:
administering NovoSeven® RT early makes a difference6
Congenital hemophilia A and B with inhibitors trial data showed NovoSeven® RT to be 93% effective at resolving bleeds.7,b
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 bleeds6,c
All bleeds
N=318
Joint bleeds
N=186
Muscle bleeds
N=74
The post hoc analysis of real-world study SMART-7™ aligns with NovoSeven® RT clinical trial results for hemophilia patients with inhibitors experiencing mild-to-moderate bleeding episodes.6,7
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 indicated that effective bleed control was defined as no additional hemostatic medication (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.6
NovoSeven® RT effectively controls joint bleeds in CHwI—fast.8
Hemostasis was achieved with a median of 2 doses.8,d
Quick readministration
NovoSeven® RT can be readministered as quickly as every 2 hours compared with 6 to 12 hours for FEIBA®9,10
Median 2 doses
A median of 2 doses helped control joint bleeds in as little as 5 hours for patients with CHwI8,d
Maximum activity
NovoSeven® RT achieved maximum activity within 5-10 minutes of infusion11,e,f
dData from a randomized, double-blind, parallel-group, multicenter study of patients with hemophilia A or B with and 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.8
eData 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.11
fFVIIa activity IU/mL.11
Teach patients the signs and symptoms of internal bleeds
This educational resource may be able to help your patients quickly identify bleeds when and where they happen. Use this tool to help your patients identify breakthrough bleeds which may require treatment on-the-go.
Ordering NovoSeven® RT
Learn how you can order NovoSeven® RT for your patients with rare bleeding disorders
Actor portrayal
When would you treat a breakthrough bleed?
Questions about how NovoSeven® RT can help your patients?
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
- 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, #268. New York, NY: National Hemophilia Foundation; 2022.
- Data on file. Novo Nordisk Inc.; Plainsboro, NJ.
- Levy GG, Asikanius E, Kuebler P, et al. 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.
- Oldenburg J, Mahlangu JN, Kim B, et al. Emicizumab prophylaxis in hemophilia A with inhibitors. N Engl J Med. 2017;377(9):809-818 and appendix.
- 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.
- 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.
- Lusher JM, Roberts HR, Davignon G, et al; and 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. doi:10.1046/j.1365-2516.1998.00209.x
- NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
- FEIBA. Package insert. Baxter Healthcare Corporation; 2024.
- 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.