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Living with factor VII deficiency?

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

How it helps

Controls bleeds, wherever they happen.

NovoSeven® RT is proven effective to treat factor VII deficiency (FVIId) at home and is 93% effective at stopping nonsurgical and surgical bleeds in people with FVIId.a  


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

93 percent effective (n=70)a

Effectively control bleeds.

90% efficacy in bleed control in trial patients.

90 percent effective
Safety

Established safety profile that comes from experience.b

NovoSeven® RT is a recombinant product, meaning it is made without human blood or plasma, which minimizes the possibility of viral contamination. Serious blood clots that form in veins and arteries with the use of NovoSeven® RT have been reported.

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

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Fast infusions

Fast to infuse.

NovoSeven® RT provides low infusion volume, so infusing takes 2 to 5 minutes.c NovoSeven® RT is given as an intravenous (IV) bolus injection.

cAdminister as a slow bolus injection over 2 to 5 minutes, depending on the dose administered.

NovoSeven® RT (90 mcg/kg)

NovoSeven® RT (90 mcg/kg) 2-5 minutes

Meet Taylor.

NovoSeven® RT fits in with what she likes to do.

Travel and mixing

Portability that fits an active lifestyle.

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

dNovoSeven® RT should be stored between 36 °F and 77 °F.

For complete storage information, please see Prescribing Information.

Xavier lives with FVIId.

Quick to mix.e

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.

MixPro instructions

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

eCompared with using histidine vials.
fFor complete storage and handling instructions, please see Prescribing Information.

Surgery

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 FVIId.

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

FAQs

About factor VII deficiency (FVIId).

Question

What is FVIId?

Answer

FVIId is a rare bleeding disorder in which there are low levels of factor VII in the blood. Factor VII plays an important role in the blood-clotting process. When there is not enough factor VII in the blood, clotting can take much longer than normal or may not occur at all.

  • Mild to moderate FVIId is marked by increased bleeding after surgery and trauma
  • Severe FVIId is marked by spontaneous, severe, and even life-threatening bleeding
Question

Who gets FVIId?

Answer
  • Children who inherit an abnormal gene from both parents. Men and women have an equal chance of being born with FVIId
  • FVIId is rare, affecting an estimated 1 in every 300,000 to 500,000 people
Question

What are the symptoms of FVIId?

Answer

The most common signs of FVIId, other than excessive bleeding after injury or invasive procedures, include:

  • Frequent nosebleeds
  • Bleeding from the gums
  • Very heavy, prolonged menstrual bleeding
  • Head bleeds in newborns
  • Prolonged bleeding following circumcision
  • Intestinal bleeding

FVIId can be detected at birth. However, some people with FVIId grow into adulthood without knowing they have it. The blood test that confirms congenital factor VII deficiency is called a clotting assay. It measures the amount of time it takes to create a clot.

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Meet Taylor

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Icon: 5-step purification process of NovoSeven® RT (Coagulation Factor VIIa [Recombinant])

Recombinant manufacturing

minimizes risk of viral contamination.

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

Please click here for Prescribing Information