Engineered for safety.

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

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 adverse events (blood clots).

  • 0.2% of bleeding episodes in patients with congenital hemophilia
  • 4% rate in people with acquired hemophilia

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

  • 0.2% of bleeding episodes in patients with congenital hemophilia
  • 4% rate in people with acquired hemophilia
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Selected Important Safety Information

WARNING: BLOOD CLOTS

  • 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.

Indications and Usage

NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) is 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 people with Glanzmann’s thrombasthenia who have 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

WARNING: BLOOD CLOTS

  • 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.

Warnings and Precautions

  • NovoSeven® RT should be used with caution if you have an increased risk for blood clots, such as with disseminated intravascular coagulation (DIC), clogged arteries, crush injury, septicemia (an infection in the blood), uncontrolled bleeding after giving birth, history of heart disease, liver disease, limited movement following surgery, in elderly people, in newborns, or if you are taking aPCCs/PCCs (activated or nonactivated prothrombin complex concentrates) with NovoSeven® RT.
  • Allergic reactions, including serious whole body allergic reactions, have been reported with NovoSeven® RT. Tell your healthcare provider if you are allergic to NovoSeven® RT, any of its ingredients, or mice, hamsters, or cows. If you think you are having an allergic reaction, call your healthcare provider right away. Some signs of allergic reaction may include shortness of breath, rash, itching, redness of the skin, and fainting/dizziness.
  • People with Factor VII deficiency should be monitored by their healthcare provider for antibodies, which can cause NovoSeven® RT to stop working properly.

Side Effects

  • 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.

Use with Other Drugs

  • Blood clots may occur if NovoSeven® RT is given with Coagulation Factor XIII (13).

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.