EMA recommends new handling measures for leuprorelin

  • Heather Mason
  • Univadis Medical News
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The European Medicines Agency’s safety committee (PRAC) has recommended measures to avoid handling errors in the preparation and administration of leuprorelin depot machines.

Leuprorelin depot formulations are administered by subcutaneous or intramuscular injections and release active substance gradually over 1-6 months. Leuprorelin medicines are marketed in many EU countries for the treatment of prostate and breast cancer, and certain female reproductive conditions, and include brand names; Eligard, Eliprogel, Enantone, Ginecrin, Lupron, Lutrate, Politrate and Procren.

The PRAC found that errors in handling included incorrect use of the needle or syringe, causing leakage, and failure to inject properly. It is now recommend that healthcare professionals familiar with its preparation should prepare and administer the medicines to patients.

The committee made recommendations for the medicine Eligard, that the patient information is updated with warnings to strictly follow the instructions for preparation and administration, and in addition, that the company marketing Eligard must replace the current device used to administer with one that is easier to handle by October 2021.

PRAC recommends that instructions for handling Lutrate Depot and its packaging is updated.

A review was initiated at the request of Germany under Article 31 of Directive 2001/83/EC. A direct healthcare professional communication (DHPC) will be sent out in due course.