Dear Healthcare Professional Letter on the risk of lack of efficacy due to incorrect reconstitution and administration of Eligard (leuprorelin acetate depot injection)
03.12.2014
In agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA), Astellas d.o.o. has sent a letter to heathcare professionals on the risk of lack of efficacy due to incorrect reconstitution and administration process of Eligard (leuprorelin acetate depot injection).
Summary
- Lack of clinical efficacy may occur due to incorrect reconstitution of the product.
- There are reports of medication errors related to storage, preparation, and reconstitution of Eligard.
- Appropriate reconstitution of Eligard is a critical step in the administration of the product to ensure the safe and effective treatment of prostate cancer patients.
- It is important to be familiar with and adhere to the instructions for appropriate methods of reconstitution and administration before using the product.
- The device will be modified to simplify reconstitution and administration and theroom storage temperature will be changed. Until approval of these changes the current instructions in section 6.6 of the SmPC and section 7 of the PL should be followed.
- The reconstitution can only be performed when the product is at room temperature.
- Testosterone levels should be evaluated in suspected cases of maladministration of Eligard.
Further information
Eligard is indicated for the treatment of hormone dependent advanced prostate cancer. The recommendations above follow reports of inappropriate technique in Eligard administration process, some of them associated with a lack of clinical efficacy in patients diagnosed with advanced prostate cancer. A number of case reports indicated a lack of efficacy, as they include analytical data of an increase of testosterone levels above the castrate level (≤50 ng/dl) and/or an increase of PSA (prostate-specific antigen) levels. A cumulative review of known cases of medication error events reported revealed a variety of errors during the preparation, mixing and administration of the product. It is very important to review and understand the detailed instructions for appropriate reconstitution and administration of Eligard that are provided in Section 6.6 "Special precautions for disposal and other handling” of the Summary of Product Characteristics and Section 7 "Information for Healthcare Professionals” of the Package Leaflet. These instructions should be read before reconstituting and administering Eligard.
Here you may view the Dear Healthcare Professional Letter.
We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.
