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Effective treatment for hemophilia A with inhibitors.

NovoSeven® RT offers established bleed control that people with hemophilia A with inhibitors have trusted for more than 30 years.a It’s also the only rFVIIa that has clinical experience for use with Hemlibra.

aFor people with hemophilia A or B with inhibitors.

How it helps

Get fast bleed control—even for the most life-threatening bleeds.b

93 percent effective

In all bleeds in hemophilia A
and B with inhibitorsc 

All bleeds refers to joint, target joint, skin, and mucous membrane, muscle, and other bleeding episodes (n=227 bleeding episodes).

90 percent effective

In all severe
bleeding episodesd  

A total of 518 severe bleeding episodes were studied. Bleeds included muscle, ENT (ear, nose, throat), CNS, joint and internal/retroperitoneal bleeds.

94 percent effective

In children within a trial with patients with hemophilia A and B with and without inhibitors

20 children younger than 12 and 8 children ages 12 to 16 were studied. Bleeds included joint, muscle and mucous membrane bleeds.

bIn compassionate use situations including surgery, central nervous system hemorrhages, severe intra-abdominal bleeding, and other life-threatening bleeding episodes.
cProven effective in the adept™2 study, one of the largest clinical trials conducted in patients with hemophilia with inhibitors. The adept™2 study included people with people with hemophilia A with inhibitors (n=66) and people with hemophilia B with inhibitors (n=6). Of those who participated in the study, 57 were treated with NovoSeven® RT and 67 were treated with vatreptacog.
dData shown from compassionate use program and 2 clinical studies including patients with hemophilia A or B with or without inhibitors and acquired hemophilia.

Safety
Novoseven injection

Safe when used with Hemlibra.

NovoSeven® RT is the only rFVIIa that has clinical experience for use with Hemlibra. If you have hemophilia A with inhibitors and use Hemlibra, NovoSeven® RT can help you manage acute bleeding episodes that require a bypassing agent.

Established safety profile that comes from experience.e

In clinical trials of NovoSeven® RT, a low rate of blood clots (0.2% of bleeds) was reported in patients with congenital hemophilia.f It’s the first FDA-approved recombinant bypassing agent for hemophilia with inhibitors. It’s the only FDA-approved bypassing agent for all ages in people with hemophilia with inhibitors.

The one and only NovoSeven® RT.

NovoSeven® RT: Over 30 years' experience controlling severe bleeds; Safe when used with Hemlibra; Approved for use in all ages; Proven safety profile for surgery. SEVENFACT: Three severe bleeds where reported of 468 studied in the PERSEPT trials; Not clinically studied with Hemlibra; Only indicated for adults and adolescents 12 years or older; Not approved for use in surgery.
NovoSeven® RT: Over 30 years' experience controlling severe bleeds; Safe when used with Hemlibra; Approved for use in all ages; Proven safety profile for surgery. SEVENFACT: Three severe bleeds where reported of 468 studied in the PERSEPT trials; Not clinically studied with Hemlibra; Only indicated for adults and adolescents 12 years or older; Not approved for use in surgery.

Compare features of treatment options and get details on what to consider when making your choice.

eCompassionate use, also known as expanded access, began enrolling in 1988; FDA approval received in 1999.
fFor people with hemophilia A or B with inhibitors.
gIn people with acquired hemophilia, NovoSeven® RT is only indicated for adults.

Fast infusions

Fast to infuse.

Faster infusion means NovoSeven® RT gets to work stopping bleeds more quickly.

NovoSeven® RT (90 mcg/kg)

2 to 5 minutes

FEIBA (75 U/kg)

37.5 minutes
NovoSeven infusion time
  • Infusing takes 2 to 5 minutes
  • NovoSeven® RT is up to 18x faster to infuse than FEIBAh-j

Fast bleed control.

Helps control joint bleeds in as few as 5 hours with a median of 2 doses.j

5 hours
  • NovoSeven® RT can be redosed every 2 hours,k which lets you dose as needed to get bleeds under control fast
  • Your hemophilia treatment center (HTC) and your doctor will help you decide which dosing schedule is best for you

hAdminister as a slow bolus injection over 2 to 5 minutes, depending on the dose administered.
iIndividual doses are compared and based on an 88-kg (194-lb) person.
jPatients are cautioned that the maximum injection or infusion rate must not exceed 2 units per kilogram of body weight per minute.
kBased on individual dosage for joint bleeds in people with hemophilia A or B with and without inhibitors.

Justin's story.

Justin lives with hemophilia A with an inhibitor. Learn about his love for travel and how NovoSeven® RT fits into his life when he’s on the go.

Travel and mixing

Room-temperature stable and travel ready.

NovoSeven® RT comes in compact packaging, and is room-temperature stable up to 77°F, so you can be on the go.l

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

For complete storage information, please see Prescribing Information.

Bob has hemophilia A with inhibitors

Quick to mix.m

NovoSeven® RT with MixPro® makes mixing a dose fast. The prefilled syringe means no extra steps to fill a syringe with diluent. See how to prepare a dose with MixPro® in our video.

MixPro instructions

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

mCompared with mixing using histidine vials.
nFor 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 is approved by the FDA for treating people with hemophilia A or B with inhibitors during and after surgery and procedures.

In fact, in a clinical trial, NovoSeven® RT was proven to effectively control bleeds throughout the surgical process. Here are the results:

Percentage of patients with satisfactory bleed control:

93% during surgery; 100% Postoperative day 2; 93% Postoperative day 5; 93% day Postoperative 6 – 26 (Study end)

The postoperative period: essential to surgical success

Talk with your doctor for more information on controlling bleeds during and after surgery or a procedure.

Why NovoSeven® RT

Explore the features of NovoSeven® RT and learn how it could fit your life. See the features

FAQs

About hemophilia A with inhibitors.

Question

What is hemophilia A?

Answer

Hemophilia is a bleeding disorder that prevents blood from clotting properly. There are a number of proteins in blood, called “clotting factors,” that work together in a series of steps to form blood clots. People with hemophilia A are missing factor VIII. Hemophilia mostly affects men, but it can also affect women. And although many people inherit the condition, about 1/3 of people with hemophilia don’t have a family history of it.

 

Question

What are inhibitors?

Answer

Inhibitors are a complication of hemophilia. People with severe hemophilia A or B are usually treated by replacing the missing factor VIII or factor IX through infusion. For some people, however, this treatment does not work. Their bodies react as though the treatment is an invader and their immune system develops antibodies, or “inhibitors,” that attack and neutralize the factor VIII or IX. When this happens, the factor is not able to stop the bleeding.

Justin
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Illustration: Removing syringe cap

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Syringe and vials of NovoSeven® RT (Coagulation Factor VIIa [Recombinant])

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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

Please click here for Prescribing Information