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Shire is pleased to provide you with this web site and its content for general informational purposes. Please carefully read these Terms and Conditions relating to the use of our web site. Shire will use reasonable efforts to ensure that the information is accurate at the time it is added to the web site. Please note, however, that Shire makes no warranties or representations that the information is accurate and accepts no liability for any errors or omissions in the content of the site or any losses or damage that may arise from relying on this information. The information may be changed by Shire at any time. By using this web site, you agree to these Terms and Conditions without limitation or qualification.

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Links to Third Party Web Sites

The web site may from time to time contain hypertext-links to third parties’ web sites. Shire is not responsible for, and accepts no liability in respect of, any information or opinion contained on any other such web site. As Shire has no control over such web sites and because their content is subject to change without notice to Shire, it is the responsibility of the user of the web site to ensure that any information accessed is accurate and that software which is downloaded from that web site is free of viruses or any other items of a destructive nature. Shire accepts no liability whatsoever in respect of any loss, damage, costs or liability incurred through any such downloaded material.

Information Is No Substitute for Consulting a Health Professional

The information on the Web site is intended only to provide knowledge of disease information. This information should not be considered complete and should not be used in place of a visit, call, consultation, or advice of your physician or other health care provider. Shire does not recommend the self-management of health problems. Should you have any health care-related questions, please call or see your physician or other health care provider promptly. You should never disregard medical advice or delay in seeking it because of something you have read here. Information is not necessarily accurate, complete, or current.

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Shire makes no representation or warranty that access to the web site will be available on a timely basis, will be uninterrupted, or will be error-free. Shire does not warrant that these pages, or the server that makes them available, are free of viruses or other harmful elements. In no event shall Shire, its affiliates and subsidiaries, and their respective officers, directors, employees, agents, representatives, information providers, and licensors and their respective heirs and assigns, be liable for any direct indirect, incidental, consequential, exemplary, special, punitive, or other damages even if informed of the possibility of such damages. The above exclusion may not apply in jurisdictions to the extent that they do not allow the exclusion of implied warranties.

Any personally identifiable information in electronic communications to this web site is governed by Shire’s Privacy Policy. Shire shall be free to use or copy all other information in any such communications, including any ideas, inventions, concepts, techniques or know-how disclosed therein, for any purposes, including disclosure to third parties and/or developing, manufacturing and/or marketing products or services. Information intended for U.S. residents only.

All materials and information appearing on the Web site are intended for U.S. residents only. These Terms and Conditions were last updated: February 4, 2009.

Detailed Important Risk Information
Prescribing Information (PI)
ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] Important Information
Indications

ADYNOVATE is an injectable medicine that is used to help treat and control bleeding in children and adults with hemophilia A (congenital Factor VIII deficiency). Your healthcare provider may give you ADYNOVATE when you have surgery. ADYNOVATE can reduce the number of bleeding episodes when used regularly (prophylaxis).

ADYNOVATE is not used to treat von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

You should not use ADYNOVATE if you:

  • Are allergic to mice or hamster protein
  • Are allergic to any ingredients in ADYNOVATE or ADVATE [Antihemophilic Factor (Recombinant)]

Tell your healthcare provider if you are pregnant or breastfeeding because ADYNOVATE may not be right for you.

You should tell your healthcare provider if you:

  • Have or have had any medical problems.
  • Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.
  • Have any allergies, including allergies to mice or hamsters.
  • Have been told that you have inhibitors to factor VIII (because ADYNOVATE may not work for you).

Your body may form inhibitors to Factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, it may stop ADYNOVATE from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.

You can have an allergic reaction to ADYNOVATE.
Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.

The common side effects of ADYNOVATE are headache and nausea. Tell your healthcare provider about any side effects that bother you or do not go away.

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.

Click here for ADYNOVATE full Prescribing Information.



ADVATE [Antihemophilic Factor (Recombinant)] Important Information
Indications

ADVATE is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called “classic” hemophilia). ADVATE is used to prevent and control bleeding in adults and children (0-16 years) with hemophilia A.
Your healthcare provider may give you ADVATE when you have surgery.
ADVATE can reduce the number of bleeding episodes in adults and children (0-16 years) when used regularly (prophylaxis).

ADVATE is not used to treat von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

You should not use ADVATE if you:

  • Are allergic to mice or hamsters.
  • Are allergic to any ingredients in ADVATE.

Tell your healthcare provider if you are pregnant or breastfeeding because ADVATE may not be right for you.

You should tell your healthcare provider if you:

  • Have or have had any medical problems.
  • Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.
  • Have any allergies, including allergies to mice or hamsters.
  • Have been told that you have inhibitors to factor VIII (because ADVATE may not work for you).

Your body may form inhibitors to factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, it may stop ADVATE from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.

You can have an allergic reaction to ADVATE.
Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.

Side effects that have been reported with ADVATE include: cough, headache, joint swelling/aching, sore throat, fever, itching, dizziness, hematoma, abdominal pain, hot flashes, swelling of legs, diarrhea, chills, runny nose/congestion, nausea/vomiting, sweating, and rash.
Tell your healthcare provider about any side effects that bother you or do not go away or if your bleeding does not stop after taking ADVATE.

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.

Click here for ADVATE full Prescribing Information.