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:

  • Contraindicated in patients with underlying liver disorders.
  • For the intermittent treatment of moderate to severe symptoms of uterine fibroids in women of reproductive age, Esmya® should only be used in women who are not eligible for surgical treatment. [Esmya® continues to be indicated for one treatment course (up to 3 months) of pre-operative treatment for moderate to severe symptoms of uterine fibroids in adult women of reproductive age.]
  • Liver function tests should be performed before starting each treatment course, monthly during the first 2 treatment courses and 2-4 weeks after stopping treatment.
  • Do not start Esmya® treatment if levels of alanine transaminase (ALT) or aspartate aminotransferase (AST) are >2 times the upper limit of normal (ULN) (isolated or in combination with bilirubin >2 times ULN).
  • Esmya® treatment should be withheld in patients whose ALT or AST levels are >3 times ULN.

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.

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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MOH Pharmacy Staff