New Safety Measures for Leuprorelin Depot in Europe

Roxanne Nelson, RN, BSN

May 18, 2020

The European Medicine Agency's (EMA's) safety committee has recommended that new measures be taken to avoid handling errors in the preparation and administration of leuprorelin depot medicines.

A review conducted by the Pharmacovigilance Risk Assessment Committee (PRAC) found that some patients have not received sufficient amounts of their medication because of handling errors. The handling errors are related to the complexity of reconstituting these products. Multiple steps are needed for some of the formulations.

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

Formulations include implants, as well as powders and solvents for the preparation of injections. Depot formulations of leuprorelin medicines are administered by either subcutaneous or intramuscular injection. The active substance is gradually released over 1 to 6 months.

Leuprorelin products are also available in a formulation for daily injections; this formulation was not included in the current review because there have been no reports of handling errors with daily-use injections.

These medicines have been authorized for use in the European Union. They are marketed in many EU countries and are available under several brand names, including Eligard, Eliprogel, Enantone, Ginecrin, Lupron, Lutrate, Politrate, and Procren.

Reports of Incorrect Usage

The review was prompted by reports of handling errors with depot formulations of leuprorelin. Reported handling errors include incorrect use of the needle or syringe, resulting in medication leakage, and failure to inject leuprorelin properly, which can lead to underdosing and a lack of efficacy.

PRAC now recommends that leuprorelin depot medicines only be prepared and administered by healthcare professionals who are familiar with the procedure and that patients not prepare or self-inject these products.

In addition to these basic recommendations, PRAC has also issued recommendations for two specific products.

For Eligard, the product information is to be updated with warnings indicating that preparation and administration instructions must be strictly adhered to and that patients need to be monitored if a handling error occurs. The company marketing Eligard, Tolmar Pharmaceuticals, is also required to replace the device currently used to administer the medicine with one that is easier to use by October 2021. The device modification will reduce the number of steps needed to prepare the medication, which is currently high.

For Lutrate Depot, PRAC has recommended that handling instructions be revised to make them easier to follow and that changes be made in packaging so that instructions are easier to find.

PRAC notes that a direct healthcare professional communication (DHPC) will be sent in due course to healthcare professionals prescribing, dispensing, or administering the medicine. The DHPC will also be published on a dedicated page on the EMA website.

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