2021-07-12 16:32:40
#update Only think about ulipristal acetate for the intermittent treatment of moderate
to severe symptoms of uterine fibroids in premenopausal women if:
• surgery and uterine artery embolisation for fibroids are not suitable, for example,
because the risks to a woman outweigh the possible benefits, or
• surgery and uterine artery embolisation for fibroids have failed, or
• the woman declines surgery and uterine artery embolisation for fibroids.
See the MHRA drug safety update on ulipristal acetate. [2021]
1.5.12 Discuss with the woman the risks and possible benefits of intermittent
treatment with ulipristal acetate.
• Advise that ulipristal acetate can be associated with serious liver injury leading to liver
failure, and the signs and symptoms to look out for.
• Measure liver function before starting ulipristal acetate, monthly for the first 2 courses
and once before each new treatment course when clinically indicated.
• If there is no underlying liver injury, and surgery and uterine artery embolisation for
fibroids are unsuitable or have failed, consider ulipristal acetate 5 mg (up to 4 courses)
for premenopausal women with heavy menstrual bleeding and fibroids of 3 cm or more
in diameter, particularly if the haemoglobin level is 102 g per litre or below.
• If a woman shows signs and symptoms of liver failure, stop ulipristal acetate and
perform liver function tests urgently. [2021]
1.5.13 Be aware that the effectiveness of pharmacological treatments for HMB may be
limited in women with fibroids that are substantially greater than 3 cm in
diameter. [2018, amended 2020]
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