Health Canada Endorsed Important Safety Information on INTELENCE*
(etravirine)

    
    New safety information regarding INTELENCE* (etravirine) and severe
    skin reactions
    

TORONTO , Oct. 19 /CNW/ - Tibotec, a division of Janssen-Ortho Inc. ("Tibotec"), in collaboration with Health Canada , would like to inform patients of important safety information regarding severe skin reactions in patients receiving HIV combination therapy including INTELENCE (etravirine) tablets. Reports have included severe allergic reactions sometimes accompanied by liver failure, and one report of death.

INTELENCE, in combination with other antiretroviral agents, is used to treat human immunodeficiency virus (HIV) in treatment-experienced adult patients who have been unsuccessfully treated with prior therapy and who are resistant to multiple antiretroviral agents including Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs).

    
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    -   Patients who develop a rash should contact their doctor immediately.
        A doctor will advise on how to manage symptoms and decide whether or
        not treatment with INTELENCE should be stopped.

    -   Severe, potentially life-threatening, and fatal skin reactions have
        been reported. Symptoms of these reactions can include severe rash,
        blistering of the skin, fever, general unwell feeling, fatigue and
        muscle or joint pain. Some of these reactions have been accompanied
        by liver failure.

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Tibotec is currently working with Health Canada to incorporate this new safety information in the Canadian Product Monograph for INTELENCE. Tibotec has also sent a letter to healthcare professionals to inform them of this new safety information. A copy of that letter is available on the Health Canada website.

This information is also available at http://www.janssen-ortho.com. For further information on Janssen-Ortho Inc.: call Suzanne Frost , Janssen-Ortho Inc., [phone]. Should you have any questions or require additional information regarding the use of INTELENCE, please contact Janssen-Ortho Inc. Medical Information Department at 1-800-567-3331 from 8:30 am to 4:30 pm Monday to Friday Eastern Standard Time (EST), by facsimile at 416-449-2658 or by email at [email protected].

Managing marketed health product-related adverse reactions depends on healthcare professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious skin reactions or hypersensitivity reactions, or other serious or unexpected adverse reactions in patients receiving INTELENCE should be reported to Tibotec or Health Canada at the following addresses:

    
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    Tibotec, a division of Janssen-Ortho Inc.
    Drug Safety Department
    19 Green Belt Drive
    Toronto, Ontario M3C 1L9
    Tel: [phone] or Fax: [phone]
    [email protected]

    Any suspected adverse reaction can also be reported to:

    Canada Vigilance Program
    Marketed Health Products Directorate
    HEALTH CANADA
    Address Locator: 0701C
    Ottawa, Ontario, K1A 0K9
    Tel: [phone] or Fax: [phone]
    To report an Adverse Reaction, consumers and health professionals may
    call toll free:
    Tel: [phone]
    Fax: [phone]
    [email protected]

    The AR Reporting Form and the AR Guidelines can be found on the Health
    Canada web site or in The Canadian Compendium of Pharmaceuticals and
    Specialties.

    http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php
    http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2008-ar-ei_guide-ldir/index-eng.php

    For other inquiries related to this communication, please contact
    Health Canada at:
    Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD)
    E-mail: [email protected]
    Tel: [phone]
    Fax: [phone]

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    Sincerely,

    "signed"

    Cathy Lau, PhD.
    Vice President
    Regulatory Affairs
    JANSSEN-ORTHO Inc.

    * All trademark rights used under license
    

For further information: Suzanne Frost, Janssen-Ortho Inc., [phone]