Brand Name(s):Esmya
Indication:Pre-operative intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women before menopause when surgical procedures are not suitable or have failed.
Rationale:
Considered:Jan-12
Review Date:Mar-26
Comments:
MHRA updated restrictions February ’21
Esmya (ulipristal) should only be used for intermittent treatment of moderate to severe symptoms of uterine fibroids before menopause and when surgical procedures (including uterine fibroid embolisation) are not suitable or have failed.
MHRA
Esmya (ulipristal acetate) for symptoms of uterine fibroids: restrictions to use and requirement to check liver function before, during and after treatment
Aug 18
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Drug safety update
Esmya (ulipristal acetate) for uterine fibroids: do not initiate or re-start treatment; monitor liver function in current and recent users
March 2018
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NICE CG44(update)
Heavy menstrual bleeding: assessment and management
Feb 2018
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NICE CG44(update)
Heavy menstrual bleeding: assessment and management
Aug 2016 Update 2020 – Recommendation from PRAC that the drug be supended. Pharmacovigilance Risk Assessment Committee (PRAC) recommends suspension of ulipristal acetate for uterine fibroids during ongoing EMA review of liver injury risk