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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.
Trusted for over 30 years
NovoSeven® RT was the first recombinant factor VIIa (rFVIIa) therapy approved for hemophilia A and B with inhibitors, and it’s the only rFVIIa treatment approved for all ages—children, adolescents, and adults.
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Bob, Chase and Sid live with hemophilia A with inhibitors. Miguel lives 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.
Important “factors” you should know about
NovoSeven® RT offers fast bleed control for even the most life-threatening bleedsa—it’s 90% effective in all severe bleeding episodes.b And, it has a proven safety profile for use before, during, and after surgery.
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aIn compassionate use situations including surgery, central nervous system hemorrhages, severe intra-abdominal bleeding, and other life-threatening bleeding episodes.
bFor hemophilia patients with inhibitors. Data shown from compassionate use program and 2 clinical studies.
Dosing designed
with you in mind
NovoSeven® RT is available in 4 vial sizes, more than any other rFVIIa therapy, so you might need fewer vials to infuse your dose. And, you can infuse quickly, in 2-5 minutes.c
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cAdminister as a slow bolus injection over 2-5 minutes, depending on the dose administered.
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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® is a registered trademark of Novo Nordisk Health Care AG.
NovoCare® is a registered trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2020 Novo Nordisk  All rights reserved.  US20NSVN00137  November 2020
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