- Indication
- Uterine Fibroids
- RAG rating
- Amber initiation
- Document type
- Decision document
- Place
- Hertfordshire and West Essex ICB
- Output type
- Pharmacy / Prescribing
Linzagolix
HERTFORDSHIRE AND WEST ESSEX AREA PRESCRIBING COMMITTEE (HWE APC)
Linzagolix for treating moderate to severe symptoms of uterine Fibroids
AMBER INITIATION
Recommended for initiation by specialists, ongoing prescribing in primary care.
Name generic (trade) Linzagolix
What it is Non-peptide GnRH receptor antagonist
Indication Licensed for treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age
Date decision last revised July 2025
NICE NICE TA 996 recommended
HWE APC recommendation:
Linzagolix is recommended, as an option for treating moderate to severe symptoms of uterine fibroids in adults of reproductive age, in line with the recommendations in NICE TA996; to be used only for longer-term treatment (normally for more than 6 months) and at the following dosage;
- with hormonal add-back therapy: 200 mg once daily
- without hormonal add-back therapy: 200 mg once daily for 6 months, then 100 mg once daily
Linzagolix 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
If people with the condition and their healthcare professional consider GnRh antagonists with add back hormonal therapy to a be suitable treatment, after discussing the advantages and disadvantages of all the options, the least expensive suitable treatment choice should be used.
AMBER INITIATION
Specialists’ responsibilities include:
At initiation
- provide information to the patient relating to the safe and effective use such as, but not limited to, ongoing BMD monitoring requirements and advice on contraception
- advise patient on action to take if intolerance/significant side-effects develop prior to next follow up appointment and advise, if required, to contact initiating specialist for further treatment advice.
This information should be included in the clinic letter to primary care clinicians
During follow up care
- to arrange and review DEXA scan (recommended after one year of treatment) and ongoing BMD monitoring thereafter.
- to undertake initial and follow up reviews for efficacy and tolerance and advise primary care of the ongoing treatment plan.
During treatment, periodic check-ups must be carried out according to standard clinical practice.
Further information: for latest updates and more detailed information, including contra-indications, cautions and special warnings; please refer to summary of product characteristics SPC)
Linzagolix is a black Triangle drug ▼ report all suspected adverse reactions at Yellow Card | Making medicines and medical devices safer.
- Version number
- 1.1
- Developed by
- Pharmacy and Medicines Optimisation Team, Hertfordshire and West Essex (HWE) ICB with relevant HWE ICS stakeholders
- Approved by
- Hertfordshire & West Essex Area Prescribing Committee
- Date approved / updated
- July 2025
- Review date
- This HWE APC 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.
- Superseded version
- Version 1.0, September 2024