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Effective bleed control for people with acquired hemophilia.

NovoSeven® RT is the only bypassing agent that is approved by the FDA for acquired hemophilia.

Why NovoSeven® RT?

How it helps

Recombinant manufacturing

Fast infusions

Surgery

FAQs

Starting treatment

Why NovoSeven® RT?

How it helps

Safety

Fast infusions

Surgery

FAQs

Starting treatment

How it helps

Proven to be effective.

As a first-line treatment, NovoSeven® RT is 95% effective and recommended by an international consensus.a,b  

aInternational consensus based on research from Tiede A, Collins P, Knobeln P, et al. International recommendations on the diagnosis and treatment of acquired hemophilia A. Haematologica. 2020;105:1-44.

bEfficacy was assessed in 103 bleeding episodes in a review of 139 patients with acquired hemophilia.

92 percent effective
Recombinant Manufacturing

Made without human blood or plasma

Recombinant manufacturing means NovoSeven® RT is made without any human blood or plasma, which minimizes the possibility of viral contamination. 

Icon: Microscrope
Fast infusions

Lower volume means fast infusion.

Because it's a low-volume treatment, NovoSeven® RT takes 2 to 5 minutes to infuse.b 


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

Volume

6.3 mL

Infusion time

2 to 5 minutes
Volume of 6.3 mL with infusion time of 2 to 5 minutes

cBased on the initial dose for a 70-kg patient with acute bleeding.

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 is effective for preventing bleeds during and after surgery and procedures in people with acquired hemophilia.

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

FAQs

About acquired hemophilia (AH).

Question

What is acquired hemophilia?

Answer

Acquired hemophilia is a bleeding disorder that prevents blood from clotting properly. Unlike congenital hemophilia, which is an inherited disorder, acquired hemophilia is not present at birth; it develops suddenly. When a person develops acquired hemophilia:

  • Their body develops antibodies, or "inhibitors," that fight its own blood-clotting factors, mostly factor VIII
  • Spontaneous, uncontrolled bleeding can occur
     
Question

Who gets acquired hemophilia?

Answer

Acquired hemophilia occurs in people with no personal or family history of bleeding disorders. It is very rare, occurring in only about 1 to 1.5 per million people each year. It usually affects older people, as well as women who have recently given birth.

Acquired hemophilia can occur in association with other underlying conditions that involve the immune system, like cancer, other autoimmune diseases, or pregnancy. In about half of cases, there is no clear medical condition or reason that it happens.
 

Question

What are the symptoms of acquired hemophilia?

Answer

Acquired hemophilia can happen without warning. The most common symptoms are:

  • Bleeding into the skin (bruising)
  • Bleeding into soft tissues
  • Internal bleeding
  • Excessive bleeding following childbirth or surgery

Acquired hemophilia is diagnosed with laboratory tests that measure clotting time of blood and factor VIII levels.
 

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

Recombinant manufacturing

minimizes risk of viral contamination.

Learn about proven safety

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