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Important Safety Information  |  Prescribing Information
NovoSeven RT Coagulation Factor VIIa (Recombinant).
NovoSeven® RT is used to treat bleeding episodes in people with hemophilia A or B with inhibitors, congenital Factor VII deficiency, Glanzmann’s thrombasthenia with resistance to platelets, and acquired hemophilia.
An animated image of a patient bicycles into frame as the words ‘hemophilia B: with inhibitors, with support, with community, with Novo Nordisk’ slide into frame.
An animated image of a patient bicycles into frame as the words ‘hemophilia B: with inhibitors, with support, with community, with Novo Nordisk’ slide into frame.
I feel like having hemophilia B is definitely more of a challenge than having hemophilia A. They have a lot more geared to them in this community as far as treatments and products. With an inhibitor, it makes it that much more different.  
  — Person with hemophilia B with inhibitors  
You have more than just hemophilia B with inhibitors. You have support, a community, and a partner in Novo Nordisk. NovoSeven® RT has over 30 years of experience treating people with hemophilia B with inhibitors.
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Selected Important Safety Information
What is the most important information I should know about NovoSeven® RT?
NovoSeven® RT may cause serious side effects, including:
• Serious blood clots that form in veins and arteries with the use of NovoSeven® RT have been reported
• Your healthcare provider should discuss the risks and explain the signs and symptoms of blood clots to you. Some signs of a blood clot may include pain, swelling, warmth, redness, or a lump in your legs or arms, chest pain, shortness of breath, or sudden severe headache and/or loss of consciousness or function
• Your healthcare provider should monitor you for blood clots during treatment with NovoSeven® RT
Please click here or scroll below for additional Important Safety Information.
Get support in your community
Connect with a Rare Blood Community Liaison (RBCL) to get personalized support, find local events, and learn more about NovoSeven® RT.
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Here for you in all seasons.
Day to day and season to season, experience fast bleed control for even the most life-threatening bleeds with NovoSeven® RT.a
NovoSeven® RT is:
93% effective
In all bleeds in hemophilia A and B with inhibitorsb,c
90% effective
In all severe bleeding episodesd,e
 Why NovoSeven® RT? 
aIn compassionate use situations including surgery, central nervous system hemorrhages, severe intra-abdominal bleeding, and other life-threatening bleeding episodes.
bProven effective in the adept™2 study, one of the largest clinical trials conducted in patients with hemophilia with inhibitors. The adept™2 study included people with hemophilia A with inhibitors (n=66) and people with hemophilia B with inhibitors (n=6). Of those who participated in the study, 57 were treated with NovoSeven® RT and 67 were treated with vatreptacog.
cAll bleeds refers to joint, target joint, skin, and mucous membrane, muscle, and other bleeding episodes (n=227 bleeding episodes).
dData shown from compassionate use program and 2 clinical studies including patients with hemophilia A or B with or without inhibitors and acquired hemophilia.
eA total of 518 severe bleeding episodes were studied. Bleeds included muscle, ENT (ear, nose, throat), CNS, joint and internal/retroperitoneal bleeds.
What is NovoSeven® RT?
NovoSeven® RT (coagulation Factor VIIa, recombinant) is an injectable medicine used for:
• Treatment of bleeding and prevention of bleeding for surgeries and procedures in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with a decreased or absent response to platelet transfusions
• Treatment of bleeding and prevention of bleeding for surgeries and procedures in adults with acquired hemophilia
Important Safety Information (cont’d)
• You should not use NovoSeven® RT if you have ever had allergic (hypersensitivity) reactions, including severe, whole body reactions (anaphylaxis) to NovoSeven® RT, any of its ingredients, or mice, hamsters, or cows. Signs of allergic reaction include shortness of breath, rash, itching (pruritus), redness of the skin (erythema), or fainting/dizziness
What should I tell my healthcare provider before using NovoSeven® RT?
• Tell your healthcare provider if you have any of the following, as these may increase your risk of blood clots:
 
◦ congenital hemophilia and are also receiving treatment with aPCCs (activated prothrombin complex concentrates)
◦ are an older patient particularly with acquired hemophilia and receiving other agents to stop bleeding
◦ history of heart or blood vessel diseases
• Tell your healthcare provider and pharmacist about all the medicines you take, including all prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies
What are the possible side effects of NovoSeven® RT?
• The most common and serious side effects are blood clots
• Tell your healthcare provider about any side effects that bother you or do not go away, and seek medical help right away if you have signs of a blood clot or allergic reaction
Please click here for Prescribing Information.
NovoSeven® RT is a prescription medication.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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