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| NovoSeven® RT is indicated for congenital hemophilia A or B with inhibitors, congenital Factor VII deficiency, Glanzmann’s thrombasthenia with refractoriness to platelets, and acquired hemophilia. |
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| Get the facts on rFVIIa treatments |
| NovoSeven® RT is a rFVIIa with proven efficacy, safety and versatility for more indications than SEVENFACT®: |
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NovoSeven® RT is indicated for hemophilia A or B with inhibitors in patients of all ages.1 |
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SEVENFACT ISN’T2 |
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NovoSeven® RT is indicated for perioperative management.1 |
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SEVENFACT ISN’T2 |
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NovoSeven® RT is clinically proven safe to use with Hemlibra®.3,a |
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SEVENFACT ISN’T |
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NovoSeven® RT is also indicated for acquired hemophilia, Glanzmann’s thrombastheniab and congenital factor VII deficiency.1 |
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SEVENFACT ISN’T2 |
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NovoSeven® RT is indicated for hemophilia A or B with inhibitors in patients of all ages.1 |
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SEVENFACT ISN’T2 |
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NovoSeven® RT is indicated for perioperative management.1 |
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SEVENFACT ISN’T2 |
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NovoSeven® RT is clinically proven safe to use with Hemlibra®.3,a |
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SEVENFACT ISN’T |
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NovoSeven® RT is also indicated for acquired hemophilia, Glanzmann’s thrombastheniab and congenital factor VII deficiency.1 |
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SEVENFACT ISN’T2 |
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SAE=serious adverse event; TMA=thrombotic microangiopathy; TE=thrombotic event.
aThe post-hoc analysis included bleeding episodes in the HAVEN 1, HAVEN 2, and HAVEN 4 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 adverse events reported in each of the 3 trials, including available narratives, were assessed. No SAEs, TMAs, or TEs were observed with use of NovoSeven® RT alone in HAVEN 1, 2, and 4. The cutoff date for the data presented was September 8, 2017.3
bwith refractoriness to platelets, with or without antibodies to platelets
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| Selected Important Safety Information |
| WARNING: THROMBOSIS |
| • |
Serious arterial and venous thrombotic events following administration
of NovoSeven® RT have been reported
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Discuss the risks and explain the signs and symptoms of thrombotic and
thromboembolic events to patients who will receive
NovoSeven® RT
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Monitor patients for signs or symptoms of activation of the coagulation
system and for thrombosis
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| Warnings and Precautions |
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Serious arterial and venous thrombotic events have been reported in clinical trials
and postmarketing surveillance
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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
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| Please click here or scroll below for additional Important Safety Information. |
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| Experience by the numbers |
| With 30+ years of experience,4 NovoSeven® RT has treated 667 CHwI patients of all ages and 3,881 bleeds.1,5,6 Clinical trials for SEVENFACT included 27 CHwI patients ages 12 and up and 468 bleeds.2 |
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| Patients treated |
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| NovoSeven® RT |
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| SEVENFACT® |
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| Bleeds treated |
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| NovoSeven® RT |
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| SEVENFACT® |
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| Disclaimer: All data presented is from clinical trials and studies for NovoSeven® RT and SEVENFACT separately. This chart is not intended to compare efficacy or safety. |
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| Indications and Usage |
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NovoSeven® RT (coagulation Factor VIIa, recombinant) is a coagulation factor
indicated for:
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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
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Treatment of bleeding episodes and perioperative management in adults with acquired
hemophilia
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| Important Safety Information (cont’d) |
| Warnings and Precautions |
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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
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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
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Laboratory coagulation parameters (PT/INR, aPTT, FVII:C) have shown no direct
correlation to achieving hemostasis
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| Adverse Reactions |
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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
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| Drug Interactions |
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Thrombosis may occur if NovoSeven® RT is administered
concomitantly with Coagulation Factor XIII
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Please click here for
Prescribing Information, including boxed Warning.
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| 1. |
NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020. |
| 2. |
SEVENFACT [package insert]. Louisville, KY: HEMA Biologics; 2020. |
| 3. |
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. |
| 4. |
Hedner U. History of rFVIIa therapy. Thromb Res. 2010;125:S4-S6. |
| 5. |
Shapiro AD, Neufeld EJ, Blanchette V, et al. Safety of recombinant activated factor VII (rFVIIa) in patients with congenital haemophilia with inhibitors: overall rFVIIa exposure and intervals following high (>240 mcg/kg-1) rFVIIa doses across clinical trials and registries. Haemophilia. 2014;20:23-31. |
| 6. |
Data on file as of 2010. Novo Nordisk Inc; Plainsboro, NJ. |
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