- Indication
- Uterine fibroids
- RAG rating
- Amber initiation
- Document type
- Decision document
- Place
- Hertfordshire and West Essex ICB
- Output type
- Pharmacy / Prescribing
- Document
- Download
Relugolix
HERTFORDSHIRE AND WEST ESSEX AREA PRESCRIBING COMMITTEE (HWE APC)
Relugolix-estradiol-norethisterone acetate for treating moderate to severe symptoms of uterine fibroids
AMBER INITIATION
Recommended for initiation by specialists, ongoing prescribing in primary care.
Name generic (trade) Relugolix-estradiol-norethisterone
What it is Non-peptide GnRH receptor antagonist Estradiol: an exogenous estradiol and agonist of the nuclear estrogen receptor Norethisterone: a synthetic progestogen
Indication Licensed for treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Date decision last revised December 2022
Decisionstatus Final
NICE / SMC Guidance NICE TA 832 recommended
HWE APC recommendation:
Relugolix–estradiol–norethisterone acetate is recommended, within its marketing authorisation, as an option for treating moderate to severe symptoms of uterine fibroids in adults of reproductive age, in line with the
recommendations in NICE TA 832.
Relugolix–estradiol–norethisterone acetate can be considered when standard non-hormonal (for example tranexamic acid, NSAIDs) and hormonal pharmacologic options (for example levonorgestrel-releasing intrauterine system, combined hormonal contraception, cyclical oral progestogens) as detailed in NICE guidance 88 ‘Heavy menstrual bleeding: assessment and management’ are unsuitable /ineffective AND the next treatment options would be injectable gonadotrophin-releasing hormone (GnRH) agonists, uterine artery embolization/surgical interventions.
AMBER INITIATION:
RECOMMENDED FOR RESTRICTED USE. INITIATION AND STABILISATION BY SPECIALISTS.
Specialists must also counsel the patient at initiation on all aspects related to the safe and effective use of this medication. This includes information to the patient on ongoing recommended monitoring such as but not limited to, the recommendation for a DXA scan after 1year of treatment.
Continuation in primary care following stabilisation of therapy, and after an assessment of tolerability and efficacy has been made by the specialist.
NICE TA 832 recommendations:
Relugolix–estradiol–norethisterone acetate is recommended, within its marketing authorisation, as an option for treating moderate to severe symptoms of uterine fibroids in adults of reproductive age.
Further information: (for latest updates and more detailed information please refer to summary of product characteristics SPC)
The SPC includes some contra-indications and cautions for use and indicates that at initiation, in patients with risk factors for osteoporosis or bone loss, a DXA scan is recommended prior to starting treatment, a complete medical history (including family history) must be taken, blood pressure must be measured, and a physical examination must be performed guided by the contraindications and warnings for use. Advice on contraception must be provided (provides adequate contraception after at least one month of treatment; any hormonal contraception needs to be stopped prior to initiation of treatment, as concomitant use of hormonal contraceptives is contraindicated.
Non-hormonal methods of contraception must be used for at least 1 month after initiation of treatment.) Pregnancy must be ruled out.
During treatment, periodic check-ups must be carried out according to standard clinical practice.
A DXA scan is recommended after 1 year of treatment to verify that the patient does not have an unwanted degree of bone mineral density loss, that exceeds the benefit of treatment with relugolix-estradiol-norethisterone.
At discontinuation, alternative contraception needs to be started immediately. (Women of childbearing
potential must be advised that ovulation will return rapidly after discontinuing treatment). Discontinuation should be considered when the patient enters menopause.
Current treatment as per NICE guidance 88 Heavy menstrual bleeding, note non-hormonal and hormonal pharmacological options (e.g. tranexamic acid or NSAIDS, levonorgestrel-releasing intrauterine system,
combined hormonal contraception, cyclical oral progesterone), GnRH agonists or surgical options.
Review date: The recommendation is based upon the evidence available at the time of publication. This recommendation will be reviewed upon request in the light of new evidence becoming available.