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Important Safety Information  |  Prescribing Information
NovoSeven® RT Coagulation Factor VIIa (Recombinant) logo.
Indicated for congenital hemophilia A or B with inhibitors, congenital Factor VII deficiency, Glanzmann’s thrombasthenia with refractoriness to platelets, and acquired hemophilia. See full indication below.
Success Speaks for Itself | Pharmacy Series
Lower volume. Faster infusion.
Compared to to FEIBA®, patients living with CHwI save time on every infusion.1,2,a
To help maximize efficiency in your pharmacy, everything needed for reconstitution is included in 1 box.
Faster to infuse
than FEIBA®1,2,b,c
NovoSeven® RT
(90 mcg/kg)a
FEIBA®
(75 U/kg)d
2-5 minutes 37.5 minutes
     
 
16x less infusion volume than FEIBA®1,2,b,c
NovoSeven® RT
(90 mcg/kg)a
FEIBA®
(75 U/kg)d
aAdminister as a slow bolus injection over 2 to 5 minutes, depending on the dose administered.
bIn patients with hemophilia A or B with inhibitors.
cIndividual doses are compared and based on an 88-kg (194-lb) person.
dPatients are cautioned that the maximum injection or infusion rate must not exceed 10 units per kilogram of body weight per minute.
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Selected Important Safety Information
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
Please click here or scroll below for additional Important Safety Information.
 
The NovoSeven® RT Difference
NovoSeven® RT is indicated for bleed control and surgery in:
CHAwI
CHBwI
AH in adults
CFVIId
GT with refractoriness to platelets.1
   
 
FEIBA® is indicated for bleed control and surgery in:
CHAwI2,e
CHBwI2,e
AH
CFVIId
GT with refractoriness to platelets.1
eFEIBA® is also indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in CHAwI and CHBwI.
NovoSeven® RT contains only rFVIIa
NovoSeven® RT has just 1 main component1
Recombinant activated Factor VII
   
 
FEIBA® has 4 main components2
Factors II, IX, and X mainly in non-activated form as well as mainly activated Factor VII
Factor VIII coagulant antigen (FVIII C:Ag) is present at a concentration of up to 1-6 units per mL of FEIBA®
Factors of the kinin-generating system are present only in trace amounts
NovoSeven® RT is a bypassing agent not made from human serum or human proteins. Recombinant manufacturing minimizes the risk of blood-borne pathogens compared to plasma-based treatments.1,3
 Why Choose NovoSeven® RT? 
Stay tuned for more information about NovoSeven® RT, as part of the Success Speaks for Itself Series.
To learn more right away, schedule a call with a Hemophilia Institutional Account Manager.
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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 (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
• 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 Prescribing Information, including Boxed Warning.
References:
1. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
2. FEIBA® [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2024.
3. National Hemophilia Foundation. MASAC Recommendations Concerning Products Licensed for the Treatment of Hemophilia and Selected Disorders of the Coagulation System, #290. New York, NY: National Hemophilia Foundation; 2024
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