Table 1.
Current indications and restrictions of use of UPA in the United Kingdom and Europe (adapted from European Medicines Agency 2018, Medicines and Healthcare Products Regulatory Agency 2018).
Indications | Liver function monitoring |
---|---|
UPA is indicated for the intermittent treatment of moderate to severe symptoms of uterine fibroids in women of reproductive age who are not eligible for surgery | Before initiation of each treatment course: perform liver function tests; do not initiate UPA in women with baseline alanine transaminase (ALT) or aspartate aminotransferase (AST) more that two times the upper limit of normal (ULN). |
UPA is indicated for one course of preoperative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age | During the first two UPA treatment courses: perform liver function tests every month. |
UPA treatment is to be initiated and supervised by a physician experienced in the diagnosis and treatment of uterine fibroids | For further treatment courses: perform liver function tests once before each new course and when clinically indicated. |
UPA is contraindicated in women with underlying liver disorders | At the end of each treatment course: perform liver function tests after 2–4 weeks. Stop UPA treatment and closely monitor women with ALT or AST more than three times the upper limit of normal; consider the need for specialist hepatology referral. |