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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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ACUTE BLEEDS
REQUIRE
URGENT ACTION
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Don’t watch and wait—give your patients an on-demand agent so they can act
quickly.
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When unexpected bleeds happen in patients with hemophilia, prompt treatment has both
short- and long-term positive impacts. Treating bleeds right away is recommended
to:1
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Improve efficacy |
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Impact the development and long-term progression of
arthropathy
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Reduce rebleeding |
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MASAC recommends rFVIIa to treat acute bleeds in patients with hemophilia A with
inhibitors on emicizumab2
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NovoSeven® RT is the only treatment of its kind with a proven safety
profile when used with Hemlibra®.3
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No serious AEs and no cases of TMA or TE demonstrated
in 3 clinical trials with use of NovoSeven® RT alone3,a
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Two cases of TMA occurred in patients treating with
emicizumab while receiving FEIBA® and NovoSeven®
RT. Simultaneous use of NovoSeven® RT and FEIBA should be
avoided4
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aAs of September 2017, the 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 adverse
events reported in each of the 3 trials, including available narratives, were
assessed.3
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| Keep scrolling for clinical data |
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| Selected Important Safety Information |
| WARNING: THROMBOSIS |
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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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In the adept™2 clinical trial, NovoSeven® RT was 93% effective in
patients with congenital hemophilia A and B with inhibitors.5,b
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Real-world results reinforce early administration of NovoSeven®
RT on all patients with inhibitors.
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In a post-hoc analysis of SMART-7™, a large, prospective, postmarketing study of
patients with CHwI, early treatment (≤1 hr) with NovoSeven® RT
effectively resolved:6,c
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bData from an international, multicenter, randomized, double-blind,
active-controlled, confirmatory phase 3 trial of patients with hemophilia A or B
with inhibitors (n=69). 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. Primary efficacy endpoint
indicated effective bleed control defined as no additional hemostatic reaction
(other than the original medication) given within 12 hours after the initial
dose.5
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cSMART-7™ was a prospective, observational, single-arm, open-label study
conducted over the course of 5 years (patients remained in study for maximum 2 years
or until 25 exposure days of ondemand rFVIIa), including 51 patients with congenital
hemophilia A or B with inhibitors 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 analyzed data set
included 482 bleeding episodes treated with rFVIIa.6
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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. |
Srivastava A, Santagostino E, Dougall A, et al. WFH Guidelines for the Management of Hemophilia,
3rd edition. Haemophilia. 2020;26(suppl 6):1-158.
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| 2. |
National Hemophilia Foundation.
MASAC recommendations concerning products licensed for the treatment of hemophilia and
other bleeding disorders,
#263. New York, NY: National Hemophilia Foundation; 2020.
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| 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.
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| 4. |
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.
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| 5. |
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.
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| 6. |
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.
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© 2021 Novo Nordisk All rights reserved. US21NSVN00065 October 2021 |
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