Janssen-Cilag, a subsidiary of Johnson & Johnson, announced that it will initiate, in consultation with French Health Authority (AFSAPPS), an Urgent Safety Restriction (USR) to change its Summary of Product Characteristics (European labeling) for Eprex/Erypo (epoetin alfa) to further ensure intravenous administration of the medicine when treating anemia in patients with chronic renal failure (CRF).
The Company anticipates that, following the USR, Eprex labeling will be updated to include a contraindication of subcutaneous use of the product in chronic renal failure patients. The USR process provides for consultation and feedback from all EU Member States within a 24-hour period.
The Company also announced that it will begin an extensive epidemiological study of patients with chronic renal failure and other conditions who are receiving erythropoietin therapy, including Eprex. Subcutaneous administration of Eprex remains available for the treatment of anemia in patients undergoing cancer chemotherapy, and elective orthopedic surgery.
There have been no reports of antibody-mediated PRCA in patients with these conditions. Ensuring intravenous administration of Eprex when treating CRF patients will reinforce several steps the Company has taken regarding rare instances of antibody-mediated Pure Red Cell Aplasia (PRCA). These steps already have resulted in a substantial shift toward physician administration of Eprex by the IV route in many major EU markets.
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