Indications and Usage
NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) is 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 people with Glanzmann’s thrombasthenia who have 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
WARNING: BLOOD CLOTS
- 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.
Warnings and Precautions
- NovoSeven® RT should be used with caution if you have an increased risk for blood clots, such as with disseminated intravascular coagulation (DIC), clogged arteries, crush injury, septicemia (an infection in the blood), uncontrolled bleeding after giving birth, history of heart disease, liver disease, limited movement following surgery, in elderly people, in newborns, or if you are taking aPCCs/PCCs (activated or nonactivated prothrombin complex concentrates) with NovoSeven® RT.
- Allergic reactions, including serious whole body allergic reactions, have been reported with NovoSeven® RT. Tell your healthcare provider if you are allergic to NovoSeven® RT, any of its ingredients, or mice, hamsters, or cows. If you think you are having an allergic reaction, call your healthcare provider right away. Some signs of allergic reaction may include shortness of breath, rash, itching, redness of the skin, and fainting/dizziness.
- People with Factor VII deficiency should be monitored by their healthcare provider for antibodies, which can cause NovoSeven® RT to stop working properly.
- 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.
Use with Other Drugs
- Blood clots may occur if NovoSeven® RT is given with Coagulation Factor XIII (13).
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 1-877-NOVO-777 (1-877-668-6777) to learn more
about Novo Nordisk assistance programs.
Novo Nordisk Hemophilia & Rare Bleeding Disorders (RBD) Co-pay Assistance Program
Details of Offer, Including Restrictions on Eligibility and Other Limitations
With the Novo Nordisk Co-pay Assistance Program, you may receive up to $12,000 per year toward your co-pay for Novo Nordisk Hemophilia and Rare Bleeding Disorder products.
You are eligible to apply for the Novo Nordisk Hemophilia & RBD Co-pay Assistance Program if you:
- Have hemophilia A and have been prescribed an appropriate Novo Nordisk factor treatment; OR
- Have congenital hemophilia A or B with an inhibitor, congenital FVII deficiency, Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, or acquired hemophilia and have been prescribed an appropriate Novo Nordisk factor treatment; OR
- Have FXIII A-subunit deficiency and have been prescribed an appropriate Novo Nordisk factor treatment; AND
- Have private/commercial insurance only
Restrictions and Limitations: You are not eligible if prescriptions are paid by any state or federally funded programs, including, but not limited to, Medicare, Medicaid, Medigap, VA, DOD, or TRICARE, or where prohibited by law. Offer not valid for prescriptions reimbursed in full by any third party payor. Offer limited to 1 card per person. Offer void where taxed, restricted, or prohibited. Offer only good in the U.S.A. Eligibility is restricted to individuals; no clubs, groups, or organizations. This savings card is not transferable and is not insurance. When you use the Novo Nordisk Hemophilia & Rare Bleeding Disorders Co-pay Assistance Card, you are certifying that you understand the program rules, terms, and conditions and that you will comply with them.
Offer excludes full cash-paying customers. You must be enrolled in a commercial insurance plan.
How to use the Novo Nordisk Co-pay Card: You must present the card to the pharmacist along with your prescription to participate in this program. You are not eligible for these savings offers if prescriptions are paid by any state or federally funded programs, including but not limited to Medicare, Medicaid, Medigap, VA, DOD, or TRICARE, or where prohibited by law. Each time you use this card, you are certifying that you understand the program rules, terms, and conditions and that you will comply with them. Please deduct the amount of the discount from any claim for reimbursement submitted to your insurance company or plan. If you have any questions regarding your eligibility or benefits, need a replacement card, or if you wish to discontinue your participation, call 1-844-NOVOSEC (1-844-668-6732) Monday-Friday, 8:00 am to 8:00 pm ET.