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Drug Release Information for the EVRA Transdermal Contraceptive System - For Health Professionals
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(PDF Version - 146 K)Contact: Bureau of Metabolism, Oncology and Reproductive Sciences
The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from Janssen-Ortho Inc.
Contact the company for a copy of any references, attachments or enclosures.
Health Canada Endorsed Important Safety Information on EVRA Transdermal Contraceptive System
March 16, 2009
Dear Health Care Professional,
Subject: Drug Release Information for the EVRA* Transdermal Contraceptive System
Janssen-Ortho Inc., in cooperation with Health Canada, wishes to provide you with new information on the average daily release rates of contraceptive hormones from the EVRA* Transdermal Contraceptive System. The EVRA* transdermal system marketed in Canada contains 6.0 mg norelgestromin (NGMN) and 0.60 mg ethinyl estradiol (EE).
Health care professionals should be aware of the following information:
The EVRA product monograph has been revised to include new information on the average daily release rates for the norelgestromin (200 µg /24 hours) and ethinyl estradiol (35 µg /24 hours) components of the transdermal system (patch). This information replaces the previously labelled daily delivery rate of norelgestromin (150 µg /24 hours) and ethinyl estradiol (20 µg /24 hours).
The new information on the average daily release rate was determined by measuring residual hormone content in patches worn for 7 days. The previously labelled delivery rate information was estimated using a different (pharmacokinetic) 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 formulation of EVRA. The pharmacokinetic estimates of systemic drug exposure to the hormonal components of the product reported in the EVRA Product Monograph remain unchanged. There is no known impact on the safety and efficacy profile of EVRA as a result of the new information on the average daily release rate.
Please refer to the Detailed Pharmacology section of Part II of the Product Monograph for EVRA for additional information regarding the methodology used to determine the new release rate for the patch.
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 the Health Canada web site. The present HPC is the result of a follow-up commitment by Janssen-Ortho Inc. in November 2006 to provide information regarding an additional study to re-evaluate the average daily amount of hormones released from the EVRA Transdermal Contraceptive System.
Janssen-Ortho Inc. continues to work closely with Health Canada to monitor ongoing clinical trials, and worldwide pharmacovigilance reports.
The current Prescribing Information is available on the 
Janssen-Ortho Inc. web site. Updates to the Prescribing Information will be posted on this website and will be provided for the next edition of The Compendium of Pharmaceuticals and Specialties.
Managing marketed health product-related adverse reactions depends on health care 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 or unexpected adverse reactions in patients receiving EVRA should be reported to Janssen-Ortho Inc. or Health Canada at the following addresses:
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
Or call toll free at 1-800-567-3331
Or email to dsscan@joica.jnj.com
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
Telephone: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Telephone: 1-866-234-2345
Fax: 1-866-678-6789
CanadaVigilance@hc-sc.gc.ca
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.
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: bmors_enquiries@hc-sc.gc.ca
Telephone: 613-941-3171
Fax: 613-941-1365
Your professional commitment in this regard has an important role in protecting the well-being of your patients by contributing to early signal detection and informed drug use.
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 letter is also available on the Janssen-Ortho Inc. web site.
Sincerely,
original signed by
Cathy Lau, Ph.D.
Vice President
Regulatory and Quality
