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. 2020 Jan 30;65(1):T15–T33. doi: 10.1530/JME-19-0238

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.