Important safety information and new prescribing information for the erythropoiesis-stimulating agents (ESAs), Aranesp^® (darbepoietin alfa) and EPREX^* (epoetin alfa)

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Contact: Marketed Health Products Directorate (MHPD)

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 Amgen Canada and Janssen-Ortho, Inc.
Contact the company for a copy of any references, attachments or enclosures.

Public Communication
Health Canada Endorsed Important Safety Information on Erythropoiesis-Stimulating Agents (ESAs): Aranesp^® (darbepoetin alfa) and EPREX^* (epoetin alfa)

April 19, 2007

Subject: Important Safety Information and New Prescribing Information for the Erythropoiesis-Stimulating Agents, Aranesp^® (darbepoetin alfa) and EPREX (epoetin alfa)

The manufacturers of the erythropoiesis-stimulating agents (ESAs), in consultation with Health Canada, would like to inform you of updated safety information and pending label changes regarding treatment with ESAs. Two ESAs, Aranesp^® and EPREX, are authorized for use in Canada. ESAs are drugs used to increase the production of red blood cells and decrease the need for red blood cell transfusion. These medicines may be used in patients with kidney failure or in patients with cancer where the anemia is associated with chemotherapy.

As a result of these updates, EPREX is no longer approved for use in patients with cancer who do not have anemia associated with chemotherapy. Therefore, none of the ESAs are approved for use in this patient population.

In consultation with Health Canada, the Canadian prescribing information for these medicines will be revised by the manufacturers to reflect the new safety information listed in the box below. Patients are advised to contact their doctor or pharmacist if they have any questions or concerns regarding their current treatment with these medicines.

Several new medical studies, have described new risks associated with the use of ESAs. These risks include cardiovascular problems, such as heart attack, heart failure, stroke, blood clots or death, as well as decreased survival in patients with cancer due to worsening of their cancer. ESAs are not authorized for use in patients with cancer who do not have anemia associated with chemotherapy. All patients should be monitored to ensure that their red blood cell levels do not exceed 120 g/L while on ESA therapy.

Signs and symptoms of serious cardiovascular events may include, but are not limited to:

• chest pain
• leg pain and swelling
• shortness of breath
• sudden weakness, numbing or tingling of face, arm or leg
• severe sudden headache, loss of vision, or loss of speech

Patients experiencing these signs or symptoms should contact their doctor immediately. Patients should NOT discontinue their medication without consulting their doctor first.

A copy of the Health Care Professional letter and this communication are available on the Health Canada website. This information is also available at http://www.janssen-ortho.com.

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 heart attack, heart failure, stroke or blood clots or other serious or unexpected adverse reactions in patients receiving Aranesp^® or EPREX should be reported to Amgen Canada (for Aranesp^® ), Janssen-Ortho Inc (for EPREX) or Health Canada at the following addresses:

Sincerely,

original signed by

David N. Churchill, MD, FRCPC
Medical Director, Nephrology
AMGEN Canada Inc.

Cathy Lau, PhD.
Vice President
Regulatory and Quality
Janssen-Ortho Inc.

For media enquiries, please contact:

Natasha Bond, Amgen Canada Inc.,
905-285-3007

Suzanne Frost, Janssen Ortho Inc.,
416-449-9444

For Additional Information, please contact:

Amgen Canada Medical Information Department
1-866-50AMGEN, from 9 a.m to 5 p.m Monday to Friday, EST

Janssen-Ortho Medical Information Department
1-800-567-3331, from 8:30 a.m. to 4:30 p.m. Monday to Friday, EST