Information Provided About EVRA* Birth Control Patch Average Daily Release Rate

    TORONTO, March 19 /CNW/ - Janssen-Ortho Inc., in cooperation with Health
Canada, is providing the public with new information on the average daily
release rates of contraceptive hormones from the EVRA(*) Transdermal
Contraceptive System (patch). The EVRA(*) patch marketed in Canada contains 6.0
milligrams (mg) of norelgestromin and 0.60 mg of ethinyl estradiol and is
approved for use in contraception (prevention of pregnancy).
    Consumers should be aware of the following information:-------------------------------------------------------------------------
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    -   The EVRA product monograph now includes new information on the
        average daily release rates of the contraceptive hormones
        norelgestromin (200 micrograms ((micro)g) every 24 hours) and ethinyl
        estradiol (35 (micro)g every 24 hours). This information replaces the
        previously labelled daily delivery rate of norelgestromin (150
        (micro)g every 24 hours) and ethinyl estradiol (20 (micro)g every 24
        hours).

    -   The new information on the average daily release rate was determined
        by measuring hormone content that remained in the EVRA patches worn
        by women for 7 days. The previously labelled delivery rate
        information was estimated using a different method. The term "release
        rate" has replaced the previously labelled term "delivery rate" as a
        more descriptive term regarding release of hormones from the patch.

    -   There has been no change to the way the EVRA patch is made. The
        estimates of actual exposure to the hormones from the EVRA patch
        (amount of contraceptive hormones actually measured in the blood
        stream) have not changed. There is no known impact on the safety and
        effectiveness of the EVRA patch as a result of the new information on
        the average daily release rate.
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    -------------------------------------------------------------------------Previous Public Advisories

    Health Canada issued three previous Public Advisories pertaining to EVRA
on November 28, 2005, March 30, 2006 and November 21, 2006. These can be found
at http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/index-eng.php.
    This information is also available at http://www.janssen-ortho.com. For
more information, patients should consult their health care professional.
Patients should NOT discontinue their medication without consulting their
physician or pharmacist first. If you have questions about EVRA, please talk
to your doctor or take the medication back to your pharmacy and speak to your
pharmacist.

    Janssen-Ortho Inc. is a research-based pharmaceutical company located in
Toronto, Canada.

    The identification, characterization, and management of marketed health
product-related adverse reactions are dependent on the active participation of
health care professionals in adverse drug reaction reporting programmes. Any
occurrences of serious and/or unexpected adverse reactions in patients
receiving EVRA should be reported to Janssen-Ortho Inc. or the Marketed Health
Products Directorate at the following addresses:-------------------------------------------------------------------------
    Janssen-Ortho Inc.
    19 Green Belt Drive
    Toronto, Ontario
    M3C 1L9
    Or call toll-free at 1-800-567-3331
    Or email to [e-mail]
    Or toll-free fax to 1-866-767-5865

    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]
    E-mail: [e-mail]

    The Adverse Reaction Reporting Form and the Adverse Reaction 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:

    Therapeutic Products Directorate (TPD)
    Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS)
    E-mail: [e-mail]
    Telephone: [phone]
    Fax: [phone]
    -------------------------------------------------------------------------

    Sincerely,

    (signed)

    Cathy Lau, Ph.D.
    Vice-President
    Regulatory and Quality

    (*) All trademark rights used under license.

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 EVRA, 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) or by facsimile at (416)
449-2658. A copy of this communication is also available on the Janssen-Ortho
website at www.janssen-ortho.com