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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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Selected Important Safety Information

What is the most important information I should know about NovoSeven^® RT?

NovoSeven^® RT may cause serious side effects, including:

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Serious blood clots that form in veins and arteries with the use of NovoSeven^® RT have been reported

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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

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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.

What is NovoSeven^® RT?

NovoSeven^® RT (coagulation Factor VIIa, recombinant) is an injectable medicine used for:

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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

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Treatment of bleeding and prevention of bleeding for surgeries and procedures in adults with acquired hemophilia

Important Safety Information (cont’d)

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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?

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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

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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?

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The most common and serious side effects are blood clots

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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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