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Selected Important Safety Information

Who should not use Novoeight®?

  • You should not use Novoeight® if you are allergic to factor VIII or any of the other ingredients of Novoeight® or if you are allergic to hamster proteins

What is the most important information I need to know about Novoeight®?

  • Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia center
  • Call your healthcare provider right away and stop treatment if you get any of the following signs of an allergic reaction: rashes or hives, difficulty breathing or swallowing, tightness of the chest, swelling of the lips and tongue, light-headedness, dizziness or loss of consciousness, pale and cold skin, fast heartbeat, or red or swollen face or hands

What is Novoeight®?

Novoeight® (antihemophilic factor, recombinant) is an injectable medicine used to control and prevent bleeding in people with hemophilia A. Your healthcare provider may give you Novoeight when you have surgery

  • Novoeight® is not used to treat von Willebrand Disease

Important Safety Information

Who should not use Novoeight®?

  • You should not use Novoeight® if you are allergic to factor VIII or any of the other ingredients of Novoeight® or if you are allergic to hamster proteins

What is the most important information I need to know about Novoeight®?

  • Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia center
  • Call your healthcare provider right away and stop treatment if you get any of the following signs of an allergic reaction:rashes or hives, difficulty breathing or swallowing, tightness of the chest, swelling of the lips and tongue, light-headedness, dizziness or loss of consciousness, pale and cold skin, fast heartbeat, or red or swollen face or hands

What should I tell my healthcare provider before using Novoeight®?

  • Before taking Novoeight®, you should tell your healthcare provider if you have or have had any medical conditions, take any medicines (including non-prescription medicines and dietary supplements), are nursing, pregnant or planning to become pregnant, or have been told that you have inhibitors to factor VIII
  • Your body can make antibodies called “inhibitors” against Novoeight®, which may stop Novoeight® from working properly. Call your healthcare provider right away if your bleeding does not stop after taking Novoeight®

What are the possible side effects of Novoeight®?

  • Common side effects of Novoeight® include inhibitors in patients who were not previously treated with factor VIII products, swelling or itching at the location of injection, and fever

Please click here for Prescribing Information.

Novoeight® is a prescription medication.

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.