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Novo Nordisk Announces New Infusion Tracking Peel-Off Labels for NovoSeven® RT

Plainsboro, N.J., January 31, 2017 – Novo Nordisk announced that NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) vials are now equipped with peel-off labels to help patients keep track of infusions. Infusion records are important for securing insurance reimbursement and can also be helpful for monitoring an individual’s treatment plan. The labels were approved by the U.S. Food and Drug Administration (FDA) in 2016.

“Providing solutions for patients and their families to manage their bleeding disorder has been and always will be a priority for Novo Nordisk,” said John Spera, vice president, marketing, Biopharmaceuticals, Novo Nordisk. “The availability of these peel-off labels and infusion logbooks will give individuals an easy way to track infusions, a crucial aspect of treatment management.” 

The peel-off labels, which offer a convenient tracking option, can be used with the new Novo Nordisk infusion logbooks, available through Hemophilia Treatment Centers and healthcare providers. Additionally, individuals using NovoSeven® RT or other factor products and their caregivers can utilize the HemaGo™ app to help track and share infusion information digitally.

About Congenital Hemophilia
Hemophilia is a genetic bleeding disorder that prevents the blood from clotting normally. It affects an estimated 20,000 people in the United States, and more than 400,000 individuals globally.1 The disorder causes internal bleeding, which commonly occurs in the spaces around joints, resulting in pain and swelling. If left untreated, it can cause permanent damage.1

About Congenital Hemophilia with Inhibitors
Inhibitors are a potential concern for people with hemophilia who are receiving replacement clotting factor treatment to control bleeds. Sometimes, when a person receives treatment to help their blood clot, the body thinks that the treatment is something foreign and harmful. When this happens, the body develops antibodies—inhibitors—that attack the replacement factor used for hemophilia treatment. These antibodies prevent the replacement clotting factor from working properly. It is important to know that this doesn’t happen to everyone. Only about 20%-30% of people with severe or moderately severe hemophilia A and less than 5% of those with hemophilia B develop inhibitors.2,3

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.

Side Effects

  • 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).

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 medication. 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.

About Novo Nordisk

Novo Nordisk is a global health care company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has nearly 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus.

Further information

Media:
Courtney Mallon        +1 609 786 4079      cyml@novonordisk.com

References

  1. National Hemophilia Foundation website. Fast Facts. Retrieved November 1, 2016. https://www.hemophilia.org/About-Us/Fast-Facts
  2. Centers for Disease Control and Prevention. Hemophilia Inhibitors. http://www.cdc.gov/ncbddd/hemophilia/inhibitors.html. Accessed June 13, 2016.
  3. Astermark, J. Basic aspects of inhibitors to factors VIII and IX and the influence of non-genetic risk factors. Haemophilia 2006; 12: 8-14.

NovoSeven® is a registered trademark and HemaGo™ is a trademark of Novo Nordisk Health Care AG.

Novo Nordisk is a registered trademark of Novo Nordisk A/S.

© 2016 Novo Nordisk     All rights reserved.     USA16HDM04949      January 2017

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