Attention News/Health Editors:
Updated Safety Information about EPREX* (epoetin alfa) Provided to Canadian Healthcare Professionals
TORONTO, Jan. 15 /CNW/ - 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:
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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:
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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
http://www.janssen-ortho.com.
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.
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