NovoSeven^® RT may cause serious side effects, including:

• 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

NovoSeven^® RT (coagulation Factor VIIa, recombinant) is an injectable medicine 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 Glanzmann’s thrombasthenia with a decreased or absent response to platelet transfusions
• Treatment of bleeding and prevention of bleeding for surgeries and procedures in adults with acquired hemophilia

NovoSeven^® RT may cause serious side effects, including:

• 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
• You should not use NovoSeven^® RT if you have ever had allergic (hypersensitivity) reactions, including severe, whole body reactions (anaphylaxis) to NovoSeven^® RT, any of its ingredients, or mice, hamsters, or cows. Signs of allergic reaction include shortness of breath, rash, itching (pruritus), redness of the skin (erythema), or fainting/dizziness

• Tell your healthcare provider if you have any of the following, as these may increase your risk of blood clots:
  • congenital hemophilia and are also receiving treatment with aPCCs (activated prothrombin complex concentrates)
  • are an older patient particularly with acquired hemophilia and receiving other agents to stop bleeding
  • history of heart or blood vessel diseases
• Tell your healthcare provider and pharmacist about all the medicines you take, including all prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies

• 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, and seek medical help right away if you have signs of a blood clot or allergic reaction