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Important Safety Information  |  Prescribing Information
NovoSeven RT Coagulation Factor VIIa (Recombinant) logo.
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.
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For 30+ years, our research and experience has supported the hemophilia B with inhibitors community. Hear Miguel share his story and why he has trusted NovoSeven® RT for 20 years.
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Miguel lives with hemophilia B with inhibitors.
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.
Made with your needs in mind.
Providing people with hemophilia and inhibitors a product that is effective and stops bleeds quickly is our priority. NovoSeven® RT offers fast bleed control in even the most life-threatening bleeds.a
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aIn compassionate use situations including surgery, central nervous system hemorrhages, severe intra-abdominal bleeding, and other life-threatening bleeding episodes.
bAll bleeds: joint, target joint, skin, mucous membrane, muscle, and other bleeding episodes (n=227 bleeding episodes).
cAdminister as a slow bolus injection over 2 to 5 minutes, depending on the dose administered.
dIndividual doses (NovoSeven® RT 90 mcg/kg and FEIBA 75 U/kg) are compared and based on an 88-kg (194-lb) person.
ePatients are cautioned that the maximum injection or infusion rate must not exceed 2 units per kilogram of body weight per minute.
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Your Hemophilia Community Liaison (HCL) is ready to provide personalized support for life with a bleeding disorder. Connect with a local HCL to ask about our product assistance programs and other resources.
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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.
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.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
All other trademarks, registered or unregistered, are the property of their respective owners.
© 2020 Novo Nordisk  All rights reserved.  US20NSVN00094  October 2020
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