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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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Proven safety profile for
Hemlibra® patients
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NovoSeven® RT is the only rFVIIa with clinical experience with Hemlibra.1,2
The concomitant use of NovoSeven® RT with Hemlibra was proven safe in
3 of the pivotal HAVEN clinical trials:2,a
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180
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bleeds treated with
NovoSeven® RT alone in HAVEN 1
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| 0 |
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SAEs, TMAs, or TEs observed with NovoSeven®
RT alone in HAVEN 1, 2, and 4
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| 0 |
new or unexpected safety
concerns
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0
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SAEs, TMAs, or TEs observed with NovoSeven®
RT alone in HAVEN 1, 2, and 4
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0
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new or unexpected safety concerns
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SAE=serious adverse event; TMA=thrombotic microangiopathy; TE=thrombotic event.
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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.2
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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 |
| • |
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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Don’t look past established
bleed control.
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NovoSeven® RT has provided trusted bleed control for over 30
years.3
It’s the most studied and experienced rFVIIa.
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treated based on clinical trials and registry data.1,4
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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 |
| • |
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. |
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;00;1-8. |
| 3. |
Hedner U. History of rFVIIa therapy. Thromb Res. 2010;125;S4-S6. |
| 4. |
Parameswaran R, Shapiro AD, Gill JC, et al. 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;100-106. |
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NovoSeven® is a registered trademark of Novo Nordisk Health Care AG.
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All other trademarks, registered or unregistered are the property of their respective owners.
© 2020 Novo Nordisk All rights reserved. US20NSVN00069 November 2020 |
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