NovoSeven: Guía completa sobre usos, dosis y efectos secundarios.

NovoSeven is an injectable medicine used to treat and prevent bleeding episodes in people with hemofilia 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.

El NovoSeven pertenece a una clase de medicamentos llamados agentes hemostáticos, que promueven la formación de coágulos sanguíneos en el lugar del sangrado cuando las proteínas naturales de coagulación sanguínea están ausentes o no funcionan correctamente. 

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. 

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 hemofilia A o 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

BOXED WARNING

NovoSeven RT can cause blood clots (thrombosis) in your arteries and veins, leading to symptoms such as chest pain, severe headache, shortness of breath, coughing up blood, swelling, redness or discoloration, or paralysis on one side of the body. Get immediate medical care if you experience any of these symptoms. 

Modo de acción

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.

NovoSeven RT: Drug Form

NovoSeven RT comes as a powder that is reconstituted with the provided diluent before administration. This drug is available in single-use vials of 1 mg, 2 mg, 5 mg, or 8 mg recombinant coagulation factor VIIa (FVIIa). 

NovoSeven RT with MixPro kits are also available from a specialty pharmacy distributor for self-administration. This kit comes in a compact package that contains: 

• Vial with NovoSeven RT powder
• Vial adapter
• Prefilled syringe with diluent
• Plunger rod

Dosis y administración

El 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: 

• Cirugía menor: 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.
• Cirugía mayor: 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 RT: How to Take

NovoSeven RT is administered by intravenous (IV) bolus injection into a vein over 2 to 5 minutes. Initially, it is administered by the healthcare provider. If you will administer NovoSeven RT at home, your healthcare provider should train you on how to properly prepare and administer it. 

NovoSeven RT must be reconstituted with the provided diluent before use. Follow the product instructions and your healthcare provider’s directions for preparing, storing, and using the reconstituted medication. 

Posibles efectos secundarios

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.

NovoSeven RT: Warnings and Precautions 

Before taking NovoSeven RT, tell your healthcare provider if you:

• Have a history of heart or blood vessel disease
• Are an older patient, particularly with acquired hemophilia, and receiving other agents to stop bleeding
• Are also receiving treatment with aPCCs (activated prothrombin complex concentrates)
• Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies
• Have had an allergic reaction to any factor VIIa product before using NovoSeven RT
• Have any allergies, including allergies to mouse, bovine, or hamster proteins
• Have been told that you have inhibitors to factor VIIa (because NovoSeven RT may not work for you)
• ¿Está embarazada o planea quedar embarazada?
• ¿Está amamantando?

Costo estimado

NovoSeven RT is an expensive specialty medicine because currently there is no generic version available. Therefore, the actual cost of this drug may vary depending on the number of vials you need for the treatment, your insurance coverage, and the pharmacy you visit.

Además, Novo Nordisk, the manufacturer of NovoSeven RT, offers financial support to patients through its NovoCare program, which includes a Copay Assistance Program and Patient Trial Program (qualified patients receive 6 doses of NovoSeven RT). Contáctanos si está interesado en finanzas o copay assistance for NovoSeven, as we can help you find and apply for the right program.