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Health Canada Endorsed Important Safety Information on Rapamune (Sirolimus)

MARKHAM, CANADA -- August 25, 2006 -- Wyeth Pharmaceuticals, Division of Wyeth Canada, in consultation with Health Canada, wishes to provide Canadian kidney transplant patients with new safety information regarding an increased risk of rejection in new kidney transplant recipients receiving a combination of anti-rejection drugs. Specifically this involves RapamuneŽ (sirolimus), mycophenolate mofetil, and corticosteroids, used in combination with interleukin-2 receptor antibody induction.

This information was discovered in the course of two clinical studies conducted to determine if this combination therapy would provide better kidney function after transplantation.

The results of these two clinical studies have shown a higher rate of acute rejection in kidney transplant patients who received the investigational combination of drugs compared to patients receiving the usual standard therapy, which includes cyclosporine or tacrolimus, following kidney transplantation.

It is important to note that these results apply only to the specific combination of drugs studied in these clinical trials. In Canada, RapamuneŽ is authorized for the prevention of rejection only in patients who have received kidney transplants, and must be used in combination with other anti-rejection drugs (such as cyclosporine or tacrolimus) in the period immediately following transplantation. Such patients should continue to use RapamuneŽ as prescribed.

Patients taking RapamuneŽ should not discontinue or change their medication without discussion with their transplant physician.

Wyeth has sent a letter to transplant physicians informing them of this new safety information. A copy of the Healthcare professional letter and this communication are available on the Health Canada website (http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/2006/index_e.html).

Wyeth continues to work closely with Health Canada to monitor adverse reactions and to ensure that up-to-date information regarding the use of RapamuneŽ is available.

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 or other serious or unexpected adverse reactions in patients receiving RapamuneŽ should be reported to Wyeth Canada, or Health Canada at the following addresses:

Wyeth Canada
Medical Information and Pharmacovigilance
50 Minthorn Blvd.
Markham, Ontario
L3T 7Y2
Tel: 1 -800-461-8844
Fax: (905) 470-4385

Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
cadrmp@hc-sc.gc.ca

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.

For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: MHPD_DPSC@hc-sc.gc.ca
Tel: (613) 954-6522
Fax: (613) 952-7738


SOURCE: Wyeth

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