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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.
 
Trust the facts.
Be confident in your
treatment choice.
NovoSeven® RT
  SEVENFACT
NovoSeven® RT has over 30 years of clinical and real-world experience in people with hemophilia B with inhibitors.a
SEVENFACT DOES NOT
It was studied in two people with Hemophilia B with inhibitors in the PERSEPT 1 clinical trial.
NovoSeven® RT is approved for use in all ages.b
SEVENFACT IS NOT
It is only approved for adults and adolescents 12 years and older.
NovoSeven® RT is approved for use before, during, and after surgery and procedures.
SEVENFACT IS NOT
NovoSeven® RT is safe when used with Hemlibra.c
SEVENFACT IS NOT
NovoSeven® RT is the only rFVIIa with 30+ years of experience controlling severe bleeds.a
SEVENFACT IS NOT
Three severe bleeds of 468 were studied in the PERSEPT 1 clinical trial.
NovoSeven® RT has over 30 years of clinical and real-world experience in people with hemophilia B with inhibitors.a
SEVENFACT DOES NOT
It was studied in two people with Hemophilia B with inhibitors in the PERSEPT 1 clinical trial.
NovoSeven® RT is approved for use in all ages.b
SEVENFACT IS NOT
It is only approved for adults and adolescents 12 years and older.
NovoSeven® RT is approved for use before, during, and after surgery and procedures.
SEVENFACT IS NOT
NovoSeven® RT is safe when used with Hemlibra.c
SEVENFACT IS NOT
NovoSeven® RT is the only rFVIIa with 30+ years of experience controlling severe bleeds.a
SEVENFACT IS NOT
Three severe bleeds of 468 were studied in the PERSEPT 1 clinical trial.
aFor people with hemophilia A or B with inhibitors.
bIn people with acquired hemophilia, it is only indicated for adults.
cNovoSeven® RT is the only rFVIIa that has clinical experience for use with Hemlibra.
When making choices about treatment with your doctor,
the facts speak for themselves.
 Why NovoSeven® RT? 
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.
Miguel is a devoted dad
with a busy lifestyle.
He also lives with hemophilia B with inhibitors.
See Miguel’s Story. Miguel has been choosing NovoSeven® RT as his rFVIIa treatment for over 20 years. Why?
NovoSeven® RT is:
90%
90% effective in all severe
bleeding episodesa
Room temperature stable
and travel ready
b
Fast to mix with our MixPro®
device. Fast to infuse. Fast to
control bleeds
c
Approved for use before,
during, and after surgery
Approved for use before,
during, and after surgery
Fast to mix with our MixPro®
device. Fast to infuse. Fast to
control bleeds
c
aData shown from compassionate use program and 2 clinical studies in patients with hemophilia A or B with or without inhibitors or acquired hemophilia.
bNovoSeven® RT should be stored between 36°F and 77°F.
cAdminister as a slow bolus injection over 2 to 5 minutes, depending on the dose administered.
 Get the Facts 
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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NovoSeven® and MixPro® are registered trademarks of Novo Nordisk Health Care AG.
All other trademarks, registered or unregistered, are the property of their respective owners.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2021 Novo Nordisk  All rights reserved.  US21NSVN00090  December 2021
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