Esmya® (ulipristal acetate): New contraindication, restricted indication and liver function monitoring requirement

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Description: 

Healthcare professionals are informed of the new contraindication, restricted indication and liver function monitoring requirement for Esmya 5mg Tablets® (ulipristal acetate). Esmya® is indicated for pre-operative and intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

Since Esmya® may carry a risk of serious liver injury, the following risk minimisation measures have been introduced:

 

Healthcare professionals should advise patients to look out for signs and symptoms of liver injury. If such signs or symptoms develop, treatment should be stopped and patients should be investigated immediately including liver function testing.

 

A Direct Healthcare Professional Communication (DHPC) letter has been issued by Zuellig Pharma Sdn. Bhd. in agreement with NPRA to highlight this safety issue. Please refer to this DHPC for further information.