- 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, following stabilisation of therapy, and after an assessment of tolerability and efficacy has been made by the specialists.
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Name
generic (trade):
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Linzagolix
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What it is:
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Non-peptide GnRH receptor antagonist
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Indication:
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Licensed for treatment of moderate to severe symptoms
of uterine fibroids in adult women of reproductive age
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Date decision last revised:
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September 2024
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NICE
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NICE TA 996 recommended
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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 should be used.
AMBER INITIATION:
- At initiation, specialists must also counsel the patient 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 and advice on required BMD monitoring thereafter. Advice on contraception must also be provided.
- 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
- Version number
- 1.0
- Developed by
- HWE ICB Pharmacy Medicines Optimisation Team
- Approved by
- HWE ICB Area Prescribing Committee
- Date approved / updated
- September 2024
- 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.
- Superseded version
- N/A