The European Medicines Agency (EMA) has started a re-evaluation of medicinal products that contain leuprorelin (sold in Belgium under the name of DEPO-ELIGARD®). This re-evaluation comes in the wake of reports of errors during preparation and administration. As a result, some patients have not been able to receive their medication in sufficient doses, rendering their treatment less effective.
In Belgium, DEPO-ELIGARD®, a drug based on leuprorelin, is used to treat advanced hormone-dependent prostate cancer, local hormone-dependent high-risk prostate cancer, and local advanced hormone-dependent prostate cancer in combination with radiotherapy.
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is re-evaluating prolonged-release formulations administered by subcutaneous or intramuscular injection that gradually release the active substance over a period of 1 to 6 months.
Errors during the preparation and administration of these products have been reported. According to reports, such errors have led to problems such as leaky syringes. PRAC is now investigating all the information and will then decide whether or not further action is required to ensure that the drug is prepared and administered correctly.
Several such prolonged-release formulations, including DEPO-ELIGARD®, require complex steps to prepare the product before it can be injected. These steps are described in the summary of product characteristics (SPC) and in the medicine’s package leaflet. Only health care professionals familiar with these procedures will be permitted to perform them. A poster and a video on this topic are also available on request from Astellas, the marketing authorisation holder.
Both state that it is important, before the product is used, that one is familiar with the instructions for reconstitution and administration of these products, and to comply with them.
Testosterone levels should be measured in case of a suspected incorrect preparation or administration of DEPO-ELIGARD®.
While PRAC is re-evaluating the information, healthcare professionals can report any problems concerning the preparation and/or administration of DEPO-ELIGARD® via firstname.lastname@example.org.
More information about this referral is available at EMA’s website.