Johnson & Johnson is instituting a best handling practices program for Eprex to reduce pure red cell aplasia associated with the product.

The program aims to educate hospital staffs, pharmacists and patients about appropriate handling of biopharmaceutical products, including Eprex (epoetin alfa).

The company is issuing guidelines on supply chain handling to wholesalers, hospitals and pharmacies. J&J also is introducing a validated "cold chain" packaging program for patient transportation of Eprex.

In addition, the company is reinforcing its shipping and handling guidelines in Eprex labeling.

"The genesis of the reinforced shipping and handling guidelines has to do with some of the factors our investigation has found to be coincident with the rise of suspected PRCA cases," J&J said.

"One of them was a shift from intravenous to subcutaneous administration, with an accompanying increase in patient self-administration. This shift made home storage of product more common, increasing the potential for temperature variability and mechanical stress," J&J said.

The best handling practices program coincides with a change in European labeling to contraindicate subcutaneous administration of Eprex in patients with chronic renal failure.

For other indications, including for patients undergoing cancer chemotherapy, Eprex may still be administered subcutaneously.

The contraindication, which will be described in a "Dear Doctor" letter, follows an investigation by the French health agency into the safety of the product.

The contraindication is the second recent European label change for Eprex. In July, J&J sent a "Dear Doctor" letter noting that labeling had dropped statements that subcutaneous administration is preferred to I.V., and that I.V. administration requires 20%-30% more of the product (¹ Also see "J&J Eprex EU Label Changed; FDA Investigating Manufacturing Fraud" - Pink Sheet, 22 July, 2002., p. 11).

In the letter, J&J recommended intravenous administration of Eprexover subcutaneous administration in chronic renal failure patients to help decrease the incidence of pure red cell aplasia.

"We've been very actively converting patients to I.V. use over the past six months," J&J said, using sales reps and the July letter.

"The approximately 70%-80% of chronic renal failure patients who are now being administered Eprex intravenously is up from approximately 25% in July."

In addition to subcutaneous administration and improper storage, J&J believes that the removal of human serum albumin from the product formulation may also be related to the rise in cases of PRCA.

The company is planning to reformulate the product using alternate stabilizers (² Also see "J&J Eprex Stability Improvements Planned In Response To Aplasia Incidence" - Pink Sheet, 16 September, 2002., p. 24).

J&J manufactures Eprex for the European market at its Manati, Puerto Rico facility. The company also markets epoetin alfa in the U.S. as Procrit , which is manufactured by Amgen. Amgen manufactures and markets epoetin alfa as Epogen in the U.S. for the treatment of anemia associated with hemodialysis.

Epogen has been associated with considerably fewer cases of PRCA, and Amgen maintains the adverse events in Eprex are likely due to J&J manufacturing changes.

J&J will conduct "an extensive epidemiological study of patients with chronic renal failure and other conditions who are receiving erythropoietin therapy, including Eprex."

J&J is forming a team that will investigate cases of PRCA associated with erythropoietin products, including Eprex. The team includes research, manufacturing, clinical and regulatory affairs staff from J&J subsidiary Janssen-Cilag, J&J Pharmaceutical Research & Development and other affiliates.

The investigations could provide the company with an opportunity to argue that PRCA is a class effect and not specific to the J&J product.

J&J Eprex “Best Handling Practices” Program Aims To Reduce PRCA Cases

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