Latest advice for prescribing Esmya is available from the National Institute for Health and Care Excellence (NICE). Following the recent concerns about the use of Esmya NICE has updated recommendations for prescribing.
Licensed indications updated:
- Ulipristal acetate is indicated for one treatment course of pre operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
- Ulipristal acetate is indicated for intermittent treatment courses of moderate to severe symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery.
Esmya must not be used in women with known liver problems.
Liver function tests (LFTs) must be performed before starting each treatment course and treatment must only be started in women with liver enzyme levels less than two times upper limit of normal.
LFTs should be repeated monthly during the first two treatment courses and two to four weeks after treatment completion. LFTs > 3x upper limit of normal require discontinuation of treatment and patient observation.