Archived - Rapamune (sirolimus) - Blood Level Measurement Changes - For the Public

Starting date:

November 26, 2009

Posting date:

December 2, 2009

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000781

This is duplicated text of a letter from Wyeth, a Pfizer Company.
Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Communication - Health Canada Endorsed Important Safety Information on Rapamune (sirolimus)

November 26, 2009

Subject: Sirolimus Blood Level Measurement Changes

Wyeth (a Pfizer company)^{Footnote *} in collaboration with Health Canada would like to inform patients that different ways to measure Rapamune in the blood produce results that cannot be substituted one for the other.

Rapamune belongs to a group of medicines called immunosuppressants. It is used to prevent rejection of transplanted kidneys and is often used in combination with other immunosuppressants and corticosteroids.

• There are various ways to measure Rapamune levels in the blood. These different methods produce different results, and these results cannot be substituted one for the other.
• Doctors and Health Care Professionals have been informed that they need to be aware of any changes in method used to measure Rapamune blood levels in order to properly adjust the dose as necessary. Always take the medicine as your Doctor tells you. Follow your Doctor's instructions and never change the dose yourself.^{Footnote 1}

Health Care Professionals will inform patients taking Rapamune exactly what dose of Rapamune to take and how often to take it. They will also monitor the quantity of the drug in patients' blood.^{Footnote 1}

Patients taking Rapamune should always take their medicine exactly as prescribed. Rapamune should not be stopped unless advised by a physician. Rapamune doses are adjusted based on age, other medications, and medical conditions.

Rapamune should be taken once a day at about the same time each day either with or without food. Rapamune should not be taken with grapefruit or grapefruit juice. Rapamune tablets should not be crushed, chewed, or split. Patients should inform their Doctor if they have difficulty taking the tablet.^{Footnote 1}

Wyeth Canada, in collaboration with Health Canada, issued a letter to Health Care Professionals informing them of important changes in monitoring the quantity of Rapamune in the blood. A copy of that letter is available on the Health Canada web site.

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 Rapamune should be reported to Wyeth Canada or Health Canada at the following addresses:

Wyeth, a Pfizer Company
Medical Information & Pharmacovigilance
50 Minthorn Boulevard
Markham, Ontario L3T 7Y2
Telephone: 1-800-461-8844
Fax: 905-470-4385

Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
Health Canada
Address Locator: 0701D
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:
Marketed Health Products Directorate (MHPD)
E-mail: MHPD_DPSC@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

Rapamune Consumer Information and a full Product Monograph can be accessed at the Wyeth web site or on the Health Canada web site. Please contact Wyeth Canada Medical Information at 1-800-461-8844 with any additional questions or concerns about Rapamune.

Sincerely,

original signed by

Dr. Neil Maresky, M.B., B.Ch.
Vice-President
Scientific Affairs