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What Is NovoSeven?

NovoSeven is an injectable medicine used to treat and prevent bleeding episodes in people with 血友病 and other bleeding disorders. It is also known by its generic name, coagulation factor VIIa (recombinant), which means this drug is produced through recombinant technology in the laboratory.

NovoSeven belongs to a class of medications called hemostatic agents, which promote blood clot formation at the site of bleeding when natural blood-clotting proteins are absent or not functioning properly.

NovoSeven was first approved by the U.S. FDA in 1999. In 2008, a room-temperature-stable formulation, NovoSeven RT (coagulation factor VIIa [recombinant]), became available in the United States.

NovoSeven RT is only available with a doctor’s prescription. Read on to learn when NovoSeven RT is used, how it works, its possible side effects, and what precautionary measures you should take.

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FDA-Approved Uses

NovoSeven RT (coagulation factor VIIa [recombinant]) is approved to treat bleeding episodes and manage bleeding during or after surgical procedures in:

  • Adults and children with 血友病A或B with inhibitors (antibodies) against clotting factor VIII or IX
  • Adults and children with congenital factor VII (FVII) deficiency
  • Adults and children with Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets
  • Adults with acquired hemophilia

作用方式

Whether you have hemophilia A or B, your healthcare provider will treat you by replacing the missing clotting factors (FVIII or IX). However, sometimes this treatment stops working when your body develops inhibitors (antibodies) against the clotting factor being replaced.

NovoSeven RT, which contains the active ingredient eptacog alfa (activated), acts as a bypassing agent. It helps promote blood clot formation at the site of injury without relying on factor VIII or IX, which may be blocked by inhibitors.

In short, NovoSeven RT helps control bleeding when the body’s clotting factors are reduced, absent, or not functioning properly. Additionally, NovoSeven RT can also be used in people with factor VII deficiency, where the body does not produce enough of this clotting factor.

How NovoSeven Copay Assistance Works

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剂量和用法

dosage of NovoSeven RT depends on your body weight (kg), the type of bleeding disorder you have, and whether it is being used to treat bleeding or prevent bleeding during surgery.

1. Dosage for Hemophilia A or B with Inhibitors

The recommended dosage for hemophilia A or B with inhibitors is 90 mcg/kg every 2 hours until hemostasis is achieved. For severe bleeding episodes, treatment may then continue at 90 mcg/kg every 3 to 6 hours after hemostasis is achieved, if continued treatment is needed.

If a patient is undergoing a surgical procedure, the NovoSeven RT dose may vary depending on the type of surgery. For instance:

  • 小手术: 90 mcg/kg immediately before surgery, then every 2 hours during surgery. After surgery, 90 mcg/kg every 2 hours for 48 hours, followed by every 2 to 6 hours until healing occurs.
  • 大型手术: 90 mcg/kg immediately before surgery, then every 2 hours during surgery and for 5 days after surgery. The dose may then be given every 4 hours until healing occurs.

2. Dosage for Congenital Factor VII Deficiency

For adults and children with congenital factor VII deficiency, the recommended dosage of NovoSeven RT to treat bleeding episodes is 15 to 30 mcg/kg every 4 to 6 hours until the bleeding stops.

In case of bleeding related to surgery, a dose of 15 to 30 mcg/kg is given before surgery and every 4 to 6 hours during surgery.

3. Dosage for Glanzmann’s Thrombasthenia

The typical NovoSeven RT dosage for adults and children with Glanzmann’s thrombasthenia to treat bleeding episodes is 90 mcg/kg every 2 to 6 hours until the bleeding stops.

The typical NovoSeven dosage to prevent bleeding related to surgery is 90 mcg/kg right before surgery, followed by repeated doses every 2 hours during surgery, and then every 2 to 6 hours after surgery to maintain hemostasis.

4. Dosage for Acquired Hemophilia

For adults with acquired hemophilia, the recommended dosage of NovoSeven RT for bleeding episodes is 70 to 90 mcg/kg every 2 to 3 hours until hemostasis is achieved.

For surgical procedures, the recommended dosage is 70 to 90 mcg/kg immediately before surgery and every 2 to 3 hours during surgery and until hemostasis is achieved.

NovoSeven Side Effects

Possible side effects:

The most serious adverse reaction associated with NovoSeven RT is abnormal blood clot formation (thrombosis). Serious blood clots can form in the veins or arteries and may lead to complications such as stroke, heart attack, or pulmonary embolism.

Other adverse reactions reported with NovoSeven RT vary depending on the condition being treated and may include fever, nausea, vomiting, and injection-site reactions.

Serious allergic reactions, including anaphylaxis, can also occur. Get immediate medical help if you experience chest pain, shortness of breath, a sudden severe headache, swelling or pain in an arm or leg, or signs of a severe allergic reaction.

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