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U.S. Department of Health and Human Services


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Enbrel (etanercept) Dear Healthcare Professional Letter May 2000

FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.

This is the retyped text of a letter from Immunex/Wyeth-Ayerst Laboratories. Contact the company for a copy of any referenced enclosures.

Important Product Information

Dear Healthcare Provider:

In order to help reduce difficulties experienced by some patients when self-administering ENBREL® (etanercept), we are writing to ask for your assistance in ensuring that all patients understand the importance of following the procedures for preparing and injecting ENBREL, as described in the instructional materials provided to you. Although the majority of patients using ENBREL have not reported problems with self-administration, the toll-free Patient Support Line continues to receive calls from patients who are experiencing difficulties in penetrating the vial stopper with the needle on the supplied syringe, resulting in bent and otherwise damaged needles.

Therefore, we ask that you instruct patients in how to properly prepare the product for injection before they leave your office. There are three methods for preparing ENBREL: the conventional approach of working on a flat surface, use of the dose preparation guide on the underside of the dose tray; or use of the Mixing Station supplied with the Dosing System starter kit. Patients using the dose preparation guide or Mixing Station should be instructed that the ENBREL vial inserted into the guide or Mixing Station must be aligned to make sure the needle goes straight into the center of the circular target area of the gray stopper. In order to keep the needle lined up with the center of the stopper, patients may need to rotate the vial slightly as they advance the needle toward the vial stopper. If the patient chooses the free hand "flat working surface" method, s/he should be told to hold the needle at a 90 degree angle to the stopper and insert it into the center of the circular target area. If a patient is not able to perform the task of preparing a dose with the chosen method, then a caregiver (e.g., a family member) should be instructed on the proper technique.

Enclosed is a revised video, Teaching Patients How to Prepare and Administer ENBREL, as well as a list of other instructional and support materials that are available. We believe that time spent with patients early on will help to reduce the number of patients experiencing difficulties. Additionally, Wyeth-Ayerst and Immunex would appreciate your feedback on the helpfulness of these educational and support materials.

Concurrent with the ongoing assessment of the educational materials, we are also evaluating changes to the current vial stopper and potentially to the product delivery configuration. We encourage you to report any problems with the preparation and administration of ENBREL® (etanercept) to Wyeth-Ayerst Product Quality Division at 1-800-99-WYETH. Please encourage your patients to call the Patient Support Line at 1-888-4ENBREL (1-888-436-2735) with any questions they may have about ENBREL. We appreciate your ongoing support and feedback.


Barbara K. Finck, M.D.
Medical Director, Rheumatology
Clinical Development
Immunex Corporation

Frederick L. Jones, III, M.D.
Director, Global Medical Affairs
Wyeth-Ayerst Pharmaceuticals

51 University Street
Seattle, WA 98101-2936


Wyeth-Ayerst Laboratories
P.O. Box 8299
Philadelphia, PA 19101-8299