Leuprorelin Depot Handling Errors Prompt EMA Review

Megan Brooks


June 14, 2019

Reports of handling errors with depot formulations of leuprorelin (leuprolide acetate, multiple brands) have prompted the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) to launch a review.

The reports indicate that "handling errors during preparation and administration can cause some patients to receive insufficient amounts of their medicine, thus reducing the benefits of treatment," the EMA said in a news release.

Leuprorelin is a gonadotrophin-releasing hormone analogue used to treat a range of sex hormone–related disorders, including prostate cancer, breast cancer, endometriosis, and precocious puberty.

The review only covered depot formulations that are given by injection under the skin or into a muscle and that release the active substance slowly over 1 to 6 months. These products include implants as well as powders and solvents for the preparation of injections.

Leuprorelin medicines are also available as daily injections, but this formulation was not included in the review because there have been no reports of handling errors with this formulation, the EMA said.

The EMA noted that several depot formulations require complex steps to prepare the injection, and handling errors with these formulations have reportedly led to problems such as leakages from the syringe or failure to deliver implants from the applicator.

The PRAC will evaluate all available data and determine whether measures are needed to ensure that the medicines are prepared and administered appropriately, the EMA said.

"While the review is ongoing, healthcare professionals should carefully follow the handling instructions for leuprorelin medicines," the agency advised.

Once their review is complete, the PRAC recommendations will be sent to the Coordination Group for Mutual Recognition and Decentralised Procedures–Human (CMDh), which will adopt a position. The CMDh is a regulatory body that represents European Union (EU) member states as well as Iceland, Liechtenstein, and Norway. It is responsible for ensuring harmonized safety standards for medicines authorized via national procedures across the EU.

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