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An established safety profile that comes from experience.a

You can rely on the safety profile of NovoSeven® RT, a recombinant therapy with a demonstrated low rate of blood clots. The most common and serious side effects are blood clots.


a
Compassionate use, also known as expanded access, began enrolling in 1988; FDA approval received in 1999.

Recombinant factor products undergo a rigorous purification process.

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Made without human blood,
plasma, or proteins

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Recombinant manufacturing
minimizes the possibility of
viral contamination

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Contains no factor
VIII or factor IX

Recombinant FAQs

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What does “recombinant” mean?

Icon: Answer

“Recombinant” means that the product is made in a laboratory. Recombinant factor products were developed in the 1990s after thousands of people with hemophilia contracted Hepatitis C or were infected with HIV through contaminated factor products derived from human blood or plasma.

Before recombinant products were developed, the only treatments available to manage bleeding disorders were derived from the human blood supply, which carries a risk of blood-borne viruses or pathogens.

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How are recombinant factor products made?

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Recombinant factor products are manufactured in a laboratory, without human-derived components. NovoSeven® RT undergoes a rigorous 5-step process to ensure safety.

1. Cell Bank
Cells are created that produce clotting factor identical to that occurring naturally in the human body.


2. Production
Clotting factor is made by cells grown under careful lab conditions.


3. Purification
A cleansing process removes any remaining impurities.


4. Preparation
The factor is prepared for long-term storage.


5. Quality control
A final inspection helps ensure a high-quality product.


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What about blood clots?

Icon: Answer

Clinical trials show that NovoSeven® RT patients experienced a low rate of blood clots.

  • 0.2% of bleeding episodes in people with hemophilia A or B with inhibitors
  • 4% rate in people with acquired hemophilia

The most common and serious side effects of NovoSeven® RT are blood clots. Serious blood clots that form in veins and arteries with the use of NovoSeven®RT have been reported. 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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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

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

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
  • 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

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