CAS alert: Esmya (ulipristal acetate) for the symptoms of uterine fibroids – restrictions to use and requirements

CAS alert: Esmya (ulipristal acetate) for the symptoms of uterine fibroids – restrictions to use and requirements

August 8, 2018

New restrictions to the use of Esmya for the symptoms of uterine fibroids have been published following completion of an EU review to investigate the link between Esmya and cases of serious liver injury.

These restrictions replace the temporary safety measures, including no new patients to be prescribed Esmya, introduced in February 2018 while the review of the association between Esmya and liver damage was ongoing.

With immediate effect, Esmya should not be used unless:

  • the new restricted indication is met, and the patient does not have an underlying liver disorder; more than one treatment course is now authorised only in women who are not eligible for surgery;
  • liver function monitoring is performed before, during and after treatment courses; and
  • the rare risk of liver damage and need for liver function monitoring have been discussed and the patient knows the signs and symptoms of liver injury and what to do if they occur.

Actions for pharmacists

Pharmacists should provide the new patient card to women when dispensing Esmya.

Copies of this card were included in a letter sent to community pharmacies from Gedeon Richter on 1st August 2018 and are also available online by searching for Esmya and selecting ‘Risk Materials’.

Pharmacists will only be required to provide the new patient card until packs of Esmya with the pre-inserted patient card reach the market.

Click here to view the CAS alert

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