What is NovoSeven® RT (Coagulation Factor VIIa [Recombinant])?

NovoSeven® RT is the only recombinant factor VII (7) Factor VII (7)
One of the 13 clotting-factor proteins that helps form blood clots. product available for the treatment of bleeding Bleeding
In hemophilia, a collection of blood in an area, such as a muscle or joint. episodes and prevention of surgical bleeding in patients with hemophilia A Hemophilia A
A bleeding disorder caused by lack of Factor VIII (8). It is sometimes called classic or standard hemophilia. or B Hemophilia B
A bleeding disorder caused by lack of Factor IX (9). with inhibitors Inhibitor
A substance made by the body that attacks factor so it cannot work as well. For example, a Factor VIII (8) inhibitor would keep Factor VIII from working with other factors and platelets to stop bleeding. to factor VIII (8) Factor VIII (8)
One of the 13 clotting-factor proteins that helps form blood clots. or factor IX (9) Factor IX (9)
One of the 13 clotting-factor proteins that helps form blood clots. , patients with acquired hemophilia Acquired hemophilia
A form of hemophilia in which the body starts producing antibodies that fight its own blood-clotting proteins. , and patients with congenital factor VII deficiency Congenital Factor VII (7) deficiency
A bleeding disorder in which there are low levels of Factor VII in the blood..

How NovoSeven® RT works

There are 13 factors Factor
A protein in the blood that helps form blood clots. in the clotting Clotting
The process of forming into a clot or clots. process. Clotting happens when each factor works together in the right order. The clotting process can be slowed or stopped if 1 factor is blocked or missing. In order for a stable clot Clot
The thickened mass of blood and cells your body forms to stop the bleeding at the place where you have been injured. to form, the deficient Deficient
A lack or shortage of something. factor in the blood-clotting Blood clotting
Also known as coagulation. It is the process of turning some of the elements in the blood into a clot. Blood clotting is the result of a sequence of actions and reactions that involve several different proteins in the blood. process must be replaced or bypassed.

NovoSeven® RT is called a bypassing agent Bypassing agent
A product that treats a bleed without the need for Factor VIII (8) or Factor IX (9). because it skips the need for factor VIII or IX in people with inhibitors, instead activating factor X (10) directly. For people with factor VII deficiency Factor VII (7) deficiency
A rare bleeding disorder in which the blood has low levels of Factor VII. Factor VII is important in the blood-clotting process because it binds to blood cells near the location of an injury and to activated platelets, setting the clotting process in motion., NovoSeven® RT is used to replace the missing factor, so the clotting process can continue.

NovoSeven® RT targets the site of injury, bypasses the inhibitor, and controls bleeds fast

 
Indications and Usage

NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) is indicated for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to FVIII or FIX and in patients with acquired hemophilia; prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B patients with inhibitors to FVIII or FIX and in patients with acquired hemophilia; treatment of bleeding episodes in patients with congenital Factor VII deficiency and prevention of bleeding in surgical interventions or invasive procedures in patients with congenital FVII deficiency.

Important Safety Information

Serious thrombotic side effects are associated with the use of NovoSeven® RT outside of the uses approved by the FDA. These thrombotic side effects are blood clots that form in arteries and veins and can cause harm and may lead to death. Your doctor should discuss the risks and explain the signs and symptoms of thrombotic side effects to you. Your doctor should monitor you for blood clots during treatment with NovoSeven® RT.

Thrombotic side effects following the use of NovoSeven® RT occurred in 0.3% of all bleeds that were treated for FDA-approved uses. The rate of 0.2% was observed in hemophilia patients with inhibitors, and the rate was higher in patients with acquired hemophilia (4%). Thrombotic events (fatal and non-fatal) have been reported following use of NovoSeven® RT for all FDA-approved uses.

Some patients have conditions that may increase the risk of thrombotic side effects. These include clogged arteries, blood clots that form throughout the body instead of at the place of injury (called disseminated intravascular coagulation), a type of blood poisoning called septicemia, and crush injury, which is when a body part is crushed or squeezed between heavy or immobile objects. Also, people taking aPCCs/PCCs (activated or nonactivated prothrombin complex concentrates) at the same time that they are taking NovoSeven® RT may be at increased risk for thrombotic side effects. NovoSeven® RT should be used with caution in patients who have an increased risk for thrombotic side effects. These include, but are not limited to, patients with a history of heart disease, liver disease, patients who have limited movement following surgery, elderly patients, and neonates (babies who are 4 weeks old or younger). In each of these situations, the potential benefit of treatment with NovoSeven® RT should be weighed against the risk of these complications.

Some patients with Factor VII deficiency have developed resistance (antibodies) to Factor VII after treatment with NovoSeven® RT. Factor VII-deficient patients should be monitored for antibody formation before and after administration of NovoSeven® RT.

People who have ever had a bad reaction to NovoSeven® RT or to proteins from mice, hamsters, or “bovines” (such as an ox or cow) should consult their physician prior to using NovoSeven® RT.

The most common side effects in patients treated with NovoSeven® RT are rash, itching, hives, fever, lowered response to treatment, and blood clots in veins.

Please click here for NovoSeven® RT Prescribing Information and Instructions for Use.

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.

NovoSeven® RT is a prescription medicine. Novo Nordisk provides patient assistance for those who qualify. Please call 1-866-310-7549 to learn more about Novo Nordisk assistance programs.