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Health professional risk communication

Archived – Updated Safety Information about EPREX (Epoetin Alfa) Provided to Canadian Healthcare Professionals – For The Public

Starting date:
January 15, 2004
Posting date:
January 15, 2004
Type of communication:
Public Communication
Source of recall:
Health Canada
New safety information
General Public
Identification number:

This is duplicated text of a letter from Janssen-Ortho Inc.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

[Text of letter begins]

Public Advisory

Updated Safety Information about EPREX* (epoetin alfa) Provided to Canadian Healthcare Professionals

Toronto, January 15, 2004 - The following updated safety information has been provided recently to healthcare professionals regarding EPREX.

EPREX has been approved in Canada since 1990 for the treatment of anemia in patients with chronic renal failure (CRF). In November 2001 and July of 2002, Janssen-Ortho informed the public of rare reports of pure red cell aplasia (PRCA) in patients taking EPREX*. As of August 31, 2003, there have been 42 reports of suspected PRCA in CRF patients taking EPREX in Canada. PRCA is a condition in which a patient develops severe anemia due to failure of the bone marrow to produce red blood cells and is characterized by a severe and sudden anemia accompanied by the feeling of tiredness and/or shortness of breath. Scientific information suggests that subcutaneous administration of some medicines, such as EPREX may increase the risk of the body producing substances (antibodies) that could reduce the effectiveness of the medicine and possibly lead to PRCA.

In Canada EPREX* is supplied in two formulations, each with a different stabilizer. One contains polysorbate-80 as the stabilizer (HSA - free) and is available in a pre-filled syringe and the other contains Human Serum Albumin (HSA) and is available in a multi-use vial. The large majority of cases of PRCA have been reported in patients with chronic renal failure being treated with the HSA-free formulation of EPREX* in a pre-filled syringe that contains polysorbate-80 when it is administered subcutaneously (under the skin). PRCA has been reported on very rare occasions in patients receiving HSA-containing EPREX. There is no evidence of an increased risk of PRCA associated with either formulation when given intravenously (into the vein).

As part of an ongoing risk minimization plan, while Janssen-Ortho continues its investigation into the factors that may contribute to PRCA, the company is making the following recommendations to healthcare professionals for patients with chronic kidney disease.

EPREX (HSA-Containing) Multi-Use Vial Formulation:

Where access to a vein is available (e.g. patients on hemodialysis), EPREX HSA-containing formulation should be administered intravenously.

Where access to a vein is not available (e.g. patients with kidney disease not yet undergoing dialysis or peritoneal dialysis patients), EPREX HSA-containing formulation may be administered subcutaneously following a risk/benefit assessment of this route of administration prior to initiating therapy.

EPREX Polysorbate-80 Containing (HSA-Free) PRE-FILLED SYRINGE Formulation:

EPREX polysorbate-80 containing (HSA-free) formulation should be administered by the intravenous route only.

Dosage and administration recommendations for all other patients are not affected by this recommendation.

Should a patient with chronic renal failure on EPREX suddenly feel tired or have sudden shortness of breath, they should immediately see their doctor. Patients should NOT discontinue their medication without consulting their doctor first.

As with all medicines, EPREX should not be used by anyone who does not require the drug to treat a disease or its symptoms.

Updated information for healthcare professionals and patients is available at

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

* All trademark rights used under license

For further information: Simone Philogène, Janssen-Ortho Inc., (416) 449-9444. Or call the Janssen-Ortho Medical Information Department at 1-800-567-3331, from 9 a.m. to 5 p.m. Monday to Friday, EST.

Any suspected adverse incident 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

Toll free for consumers and health professionals:

Tel: 866 234-2345, Fax: 866 678-6789

The AR Reporting Form and the AR Guidelines can be found on the TPD web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

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