A 40-year-old woman with symptomatic uterine fibroids (total uterine volume 580 mL, largest 6 cm intramural, heavy menstrual bleeding, Hb 8.9 g/dL) has completed her family. She refuses hysterectomy. According to current NICE guidelines, which pharmacological treatment is approved as a pre-surgical or standalone treatment for uterine fibroids?
- A Mifepristone 5 mg daily for 3 months
- B Ulipristal acetate 5 mg daily for 3-month courses
- C GnRH analogue (leuprolide) monthly injections indefinitely
- D Relugolix/elagolix with add-back therapy ✓
Explanation
After the 2020 suspension of ulipristal acetate (Esmya) by EMA due to hepatotoxicity signals (serious liver injury and transplants), it is no longer recommended for fibroid management in most countries. Relugolix (combined with add-back oestradiol/norethindrone) — a GnRH receptor antagonist — and elagolix with add-back therapy are now NICE-approved for uterine fibroids. They provide rapid symptom control without the hepatotoxic risk and the initial 'flare' of GnRH agonists. GnRH agonists remain an option pre-surgery for up to 3–6 months but cannot be used long-term as standalone therapy without add-back.
Reference: Shaw's Textbook of Gynaecology, 17th ed.
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Written and medically reviewed by the StethoPrep medical team.