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Living with congenital factor VII deficiency?

NovoSeven® RT has the proven effectiveness you expect from your treatment.

> > > How it Helps

Living with congenital factor VII deficiency?

Shown to be effective in stopping nonsurgical and surgical bleeds.

NovoSeven® RT is 93% effective at stopping nonsurgical and surgical bleeds in people with congenital FVII deficiency.a

aFrom an analysis of published cases and people who took part in trials and registries.

Portability that fits an active lifestyle.

NovoSeven® RT is room temperature stable up to 77°F, so you can be on the go. And, with compact packaging, you can take it along where you need to go.

For complete storage information, please see Prescribing Information.

Quick to mix.b

NovoSeven® RT with MixPro® makes mixing a dose as easy as attach, twist, and mix. The prefilled syringe saves time—there are no extra steps to fill a syringe with diluent.

After mixing, NovoSeven® RT may be stored at room temperature in the vial for up to 3 hours.

bCompared with mixing using histidine vials.

Fast to infuse.

NovoSeven® RT requires a low infusion volume, so infusing takes 2 to 5 minutes.

Established safety profile.

NovoSeven® RT is a recombinant product, meaning it is made without human blood or plasma, which lowers the risk of viral contamination. Plus, in clinical studies it has been shown to have a low rate of adverse events (blood clots) in patients with congenital hemophilia with inhibitors.

What if I need surgery or a procedure?

We understand that you have concerns about controlling bleeds if you ever need surgery or a procedure. The good news is that NovoSeven® RT prevents bleeds during and after surgery and procedures in people with congenital FVII deficiency.

Talk to your doctor for more information on the surgical use of NovoSeven® RT.

What about surgery and procedures?

Approved for surgical use and procedures for patients with congenital FVII deficiency.

Get information on surgery

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Recombinant manufacturing

minimizes viral contamination.

Learn about proven safety

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.