נפרולוגיה

Safety Update: Updated Information About Eprex (Epoetin Alfa) Provided To Canadian Healthcare Professionals

TORONTO, ON — July 5, 2002 —

 The following updated safety information has been provided recently to healthcare professionals to review with their patients when prescribing and dispensing Eprex®.

 Eprex has been approved in Canada since 1990 for the treatment of anemia in patients with chronic renal failure (CRF). From 1998 through April 30, 2002, 121 worldwide cases of suspected pure red cell aplasia (PRCA) have been reported in patients with CRF from the post-marketing experience with Eprex.

 As of April 30, 2002, there have been 27 reports of suspected PRCA in CRF patients in Canada. The majority of worldwide reports that the Company is aware of have been associated with Eprex, however, cases of suspected PRCA have also been reported with similar products in other countries.

 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 or shortness of breath.

 Eprex is approved to be administered by injection under the skin (subcutaneous) or into the veins (intravenous). Available scientific information suggests that the subcutaneous route of administration for some medicines, such as Eprex, may increase the likelihood of the body producing substances (antibodies) that could reduce the effectiveness of the medicine and possibly lead to events such as PRCA.

Based on reported information, the majority of PRCA cases have been seen with the subcutaneous route of administration, the predominant route of administration in most countries. The Company has communicated to healthcare professionals that where feasible, Eprex should be administered intravenously to patients with CRF while the Company investigates the cause of this adverse event.

0 תגובות

השאירו תגובה

רוצה להצטרף לדיון?
תרגישו חופשי לתרום!

כתיבת תגובה

מידע נוסף לעיונך

כתבות בנושאים דומים

© ‫ e-Med
 כל הזכויות שמורות

 

התכנים המוצגים באתר זה מיועדים לאנשי צוות רפואי בלבד

אם כבר נרשמת, יש להקליד את פרטי הזיהוי שלך
עדיין לא נרשמת? באפשרותך לבצע רישום כאן
להרשמה לאתר