The safety of NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) is proven

Treating a bleed Bleed
In hemophilia, a collection of blood in an area, such as a muscle or joint. safely is important. There are many safety concerns you should be aware of. Safety should never be ignored when treating any bleeding disorder.

NovoSeven® RT has many safety features:
  • Free of human blood or plasma Plasma
    The fluid part of the blood that contains clotting factors and other proteins.
  • Risk of thrombotic Thrombotic
    Relating to or caused by thrombosis. Thrombosis is an event that takes place when veins or arteries become blocked by platelets that are working to "plug" an injury, preventing blood from flowing normally through the body, and possibly causing a stroke.    adverse events was less than 1%*
  • Associated with a decrease in inhibitor 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.     titers Titer
    Concentration or strength of a substance; measures the strength of an inhibitor in a person’s blood.     in 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).     when used as the only factor Factor
    A protein in the blood that helps form blood clots.     agent in a study

*In patients with hemophilia A or B with inhibitors and acquired hemophilia.

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.