Leuprorelin depot medicines: PRAC recommends new measures to avoid handling errors
Press release
Human
Pharmacovigilance
Referrals
EMA’s safety committee (PRAC) is recommending measures to avoid handling errors in the preparation and administration of leuprorelin depot medicines.
A review by the PRAC found that handling errors resulted in some patients receiving insufficient amounts of their medicine. The errors reported included incorrect use of the needle or syringe, causing the medicine to leak from the syringe, and failure to inject leuprorelin properly.
The Committee is therefore recommending that only healthcare professionals familiar with the preparation steps for leuprorelin depot medicines should prepare and administer the medicines to patients. Patients should not prepare or inject these medicines themselves.
The Committee also made recommendations for particular leuprorelin depot medicines. For the medicine Eligard, the product information is to be updated with warnings to strictly follow the instructions for preparation and administration and to monitor patients if a handling error occurs. In addition, the company marketing Eligard must replace the current device used to administer the medicine with one that is easier to handle. The regulatory application for this modification should be submitted by October 2021*.
For another medicine, Lutrate Depot, the PRAC recommended that instructions for handling the medicine be revised to make them easier to follow and its packaging changed so the instructions are easier to find.
Depot formulations of leuprorelin are used to treat prostate cancer, breast cancer, certain conditions that affect the female reproductive system, and early puberty. Several formulations require complex steps to prepare the injection.
Information for patients
Information for healthcare professionals
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.
More about the medicines
Depot formulations of leuprorelin medicines are given by injection under the skin or into a muscle and they release the active substance gradually over 1 to 6 months. These medicines are used to treat prostate cancer, breast cancer, conditions that affect the female reproductive system (endometriosis and uterine fibroids), and early puberty. They include implants as well as powders and solvents for the preparation of injections.
Leuprorelin medicines are also available as daily injections but this formulation is not included in the review as there have been no reports of handling errors with daily-use injections.
Leuprorelin medicines have been authorised via national procedures. They are marketed in many EU countries and are available under several brand names, including Eligard, Eliprogel, Enantone, Ginecrin, Lupron, Lutrate, Politrate and Procren.
More about the procedure
The review of leuprorelin depot medicines was initiated at the request of Germany, under Article 31 of Directive 2001/83/EC.
The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which has issued a set of recommendations. As all leuprorelin medicines are authorised nationally, the PRAC recommendations will be forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a position. The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway. It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
*The text was updated on 20 May 2020 to clarify that the deadline of October 2021 applies to the submission of the application to modify the device.