Related resources:
Menopause: diagnosis and management NICE guideline (NG23 November 2015, updated December 2019)
Early and locally advanced breast cancer: diagnosis and management NICE guideline (NG101 July 2018)
Menopausal symptoms
- Stop systemic hormone replacement therapy (HRT) in women who are diagnosed with breast cancer.
- Do not offer HRT (including oestrogen/progestogen combination) routinely to women with menopausal symptoms and a history of breast cancer. In exceptional circumstances, offer HRT to women with severe menopausal symptoms and with whom the associated risks have been discussed (Off label).
- Offer women information and counselling about the possibility of early menopause and menopausal symptoms associated with breast cancer treatment.
- Consider selective serotonin reuptake inhibitor (SSRI) antidepressants for women with breast cancer for relieving menopausal symptoms, particularly hot flushes, but not for those taking tamoxifen (Off label).
- Do not offer soy (isoflavone), red clover, black cohosh, vitamin E or magnetic devices to treat menopausal symptoms in women with breast cancer.
Threatened miscarriage
- Advise a woman with a confirmed intrauterine pregnancy with a fetal heartbeat who presents with vaginal bleeding, but has no history of previous miscarriage, that:
• if her bleeding gets worse, or persists beyond 14 days, she should return for further assessment
• if the bleeding stops, she should start or continue routine antenatal care. - Offer vaginal micronised progesterone 400 mg twice daily to women with an intrauterine pregnancy confirmed by a scan, if they have vaginal bleeding and have previously had a miscarriage (off label).
- If a fetal heartbeat is confirmed, continue progesterone until 16 completed weeks of pregnancy.
Hormone replacement therapy (NICE CKS updated September 2022)
See Vaginal and vulval conditions in formulary for the treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women.
See NHSE Gender Dysphoria Programme
See NHS Somerset formulary Male Sex Hormone responsive conditions for testosterone for low sexual desire in postmenopausal women (off label)
See Testosterone replacement in menopause (British Menopause Society tool for clinicians 2022)
See NHS Somerset Menopause and Hormone Replacement Therapy website
| Therapeutic Area | Formulary Choices | Cost for 28 (unless otherwise stated) | Rationale for decision / comments |
|---|---|---|---|
| Calcium regulating drugs, Bone resorption inhibitors | Raloxifene | 60mg tablet: £4.07 | Third line option for secondary prevention of osteoporotic fragility fractures in postmenopausal women. Raloxifene is classified by NHS Somerset as a Black drug (not recommended) for the primary prevention of osteoporotic fragility fractures in postmenopausal women (Off-label) as per Traffic light guidance. For chemoprevention in postmenopausal women at moderate to high risk of breast cancer . The recommended dose is 60mg once daily. |
| Oestrogens | |||
| Estradiol | as Elleste Solo® | 1mg tablet: £5.06 (84) 2mg tablet: £5.06 (84) | Hormone replacement therapy for oestrogen deficiency symptoms in peri- and post-menopausal women. One tablet daily to be taken orally, may be taken continuously in hysterectomised women. In women with a uterus, a progestogen should be added for 12 - 14 days each cycle to oppose the production of an oestrogen-stimulated hyperplasia of the endometrium. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women. Therapy may start at any time in women with established amenorrhoea or who are experiencing long intervals between spontaneous menses. In patients who are menstruating, it is advised that therapy starts on the first day of bleeding. Patients changing from a cyclical or continuous sequential preparation should complete the cycle and may then change without a break in therapy. Patients changing from a continuous combined preparation may start therapy at any time if amenorrhoea is established, or otherwise start on the first day of bleeding. |
| as Evorel® | 25mcg transdermal patch: £3.42 (8) | Hormone replacement therapy for oestrogen deficiency symptoms in peri- and post-menopausal women. Appy to the skin twice weekly. For women with an intact uterus progestogen should normally be added for the prevention of adverse endometrial effects, e.g. hyperplasia and cancer. The regimen may be either cyclic or continuous sequential. Only progestogens approved for addition to oestrogen treatment may be prescribed (e.g. oral norethisterone, 1mg/day or medroxyprogesterone acetate, 2.5mg/day) and should be added for at least 12-14 days every month/28 day cycle. |
|
| 50mcg transdermal patch: £3.88 (8) | |||
| 75mcg transdermal patch: £4.12 (8) | |||
| 100mcg transdermal patch: £4.28 (8) | |||
| as Lenzetto® | 1.53mg per metered dose transdermal spray: £6.90 (56) | Hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women at least 6months after last menses or surgical menopause as per traffic light guidance. (PAMM May 2020) Administered once daily, either as a monotherapy or as a continuous sequential treatment (when combined with a progestogen) |
|
| Tibolone is non-formulary Increased risk of stroke in older women should be taken into account in prescribing decisions. See MHRA Drug Safety Update (December 2014) for Tibolone: benefit-risk balance. |
|||
| Oestogens combined with progestogens | |||
| Estradiol with norethisterone | as Elleste Duet® | 1 and 1mg tablet: £9.20 (84) 2 and 1mg tablet: £9.20 (84) | Hormone replacement therapy for oestrogen deficiency symptoms in post- and peri-menopausal women. This product is a continuous sequential HRT. One tablet to be taken daily for the first 16 days, followed by one pale green tablet for the next 12 days. A new cycle should then begin without any break. Therapy may start at any time in patients with established amenorrhoea or who are experiencing long intervals between spontaneous menses. In patients who are menstruating, it is advised that therapy starts on the first day of bleeding. Patients changing from another cyclical or continuous sequential preparation should complete the cycle and may then change to without a break in therapy. Patients changing from a continuous combined preparation may start therapy at any time if amenorrhoea is established, or otherwise start on the first day of bleeding. |
| as Novofem® | 1 and 1mg tablet: £11.43 (84) | Alternative if Elleste Duet not available (January 2020) | |
| as Evorel Sequi® | 3.3 and 11.2 mg transdermal patch: £11.09 (8) | Hormone replacement therapy for oestrogen deficiency symptoms in peri- and post-menopausal women. Appy to the skin twice weekly. |
|
| as Kliofem® | 2 and 1mg tablet: £11.43 (84) | Hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women with more than 1 year since last menses. This is continuous combined HRT intended for use in women with an intact uterus. One tablet should be taken orally once a day without interruption, preferably at the same time every day. |
|
| as Kliovance® | 1 and 0.5mg tablet: £13.20 (84) | ||
| as Evorel Conti® | 3.2 and 11.2mg transdermal patch: £13.00 (8) | Hormone replacement therapy for oestrogen deficiency symptoms in post-menopausal women more than 6 months post-menopause (or 18 months since last period). Appy to the skin twice weekly. |
|
| Estradiol with progesterone | as Bijuve® | 1 and 100mg capsule: £8.14 | Hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women with intact uterus and with at least 12 months since last menses as per Traffic light guidance. The experience in treating women older than 65 years is limited. (SPF Nov 21) One to be taken daily. |
| Conjugated oestrogens with medroxyprogesterone. | as Premique Low Dose® | 0.3 and 1.5mg modified release tablet: £6.52 (84) | Hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women with an intact uterus. Take one tablet daily. |
| Estradiol with drospireone as Angeliq®is classified as Black (not recommended) as per Traffic light guidance. | |||
| Progestogens | |||
| Progesterone | Micronised progesterone (sometimes called body identical, or natural) is chemically identical to the human hormone. | ||
| as Gepretix® | 100mg micronised capsule: £4.62 (30) | For women receiving oestrogen replacement therapy there is an increased risk of endometrial cancer which can be countered by progesterone administration. The recommended dose is 200 mg daily at bedtime, for twelve days in the last half of each therapeutic cycle (beginning on Day 15 of the cycle and ending on Day 26). Withdrawal bleeding may occur in the following week. Alternatively 100 mg can be given at bedtime from Day 1 to Day 25 of each therapeutic cycle, withdrawal bleeding being less with this treatment schedule. |
|
| as Utrogestan® | 100mg micronised capsule: £6.60 (30) | ||
| 200mg micronised vaginal capsule: £21.00 (21) | For threatened miscarriage as per traffic light guidance, offer vaginal micronised progesterone 400 mg twice daily to women with an intrauterine pregnancy confirmed by a scan, if they have vaginal bleeding and have previously had a miscarriage. (Off label) If a fetal heartbeat is confirmed, continue progesterone until 16 completed weeks of pregnancy. Acute trusts to provide initial supply to avoid delay in starting. (4 weeks supply (or if the patient is >12 weeks pregnant, then enough to last up until 16 weeks). If a 4 week supply doesn’t take the patient up to 16 weeks, then primary care to provide the remainder. |
||