| Formulary Chapter 6: Endocrine system - Full Chapter
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| Chapter Links... |
 NTAG Endocrine System Recommendations |
| Details... |
| 06.04.01 |
Female sex hormones and their modulators |
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Oestrogens and Hormone Replacement Therapy HRT |
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Oestrogen conjugated tablets 625microgram and 1.2mg (Premarin®)
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Formulary
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Estradiol patches/gel/spray
(Oestrogen only patches/gel)
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Formulary
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- Twice weekly matrix patches releasing approximately 25, 37.5 (Estradot® only), 50, 75 & 100 microgram/24 hours (Estradot®,Evorel®, Estraderm® MX);
- Weekly matrix patches releasing approximately 25, 50, 75 & 100 microgram/24 hours (Femseven®);
- Once weekly matrix patches releasing approx. 50 & 100 microgram estradiol/24 hours (Progynova TS®)
- Estradiol 0.1% gel (Sandrena®)
- Estradiol 0.06% gel (Oestrogel®)
- Approved for use in gender dysphoria therapy
- Approved for use as hormone replacement therapy
- Estradiol 1.53mg/spray transdermal spray (Lenzetto®)
- Approved as an alternative to patches and gels for patients who have issues with absorption, find patch adhesive irritating or the gel messy
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Estradiol tablets
(Oestrogen only tablets)
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Formulary
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Ethinylestradiol
(Oestrogen only tablets)
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Formulary
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- Note: ethinylestradiol 2microgram tablets are
 unlicensed.
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Continuous combined HRT patch (Evorel® Conti)
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Formulary
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Combined cyclical HRT tablet (Elleste Duet®)
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Formulary
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- Pack of 16 x 1mg estradiol tablets + 12 x 1mg estradiol and 1mg norethisterone tablets
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Combined cyclical HRT tablet (Femoston®)
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Formulary
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- Femoston® 1/10 Tablets:
- Pack of 14 x 1mg estradiol tablets + 14 tablets containing estradiol 1mg and dydrogesterone 10mg
- Femoston® 2/10 Tablets:
- Pack of 14 x 2mg estradiol tablets + 14 tablets containing estradiol 2mg and dydrogesterone 10mg
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Continuous combined HRT tablets (Elleste-duet Conti, Kliofem, Kliovance, Femosten Conti, Premique-low dose)
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Formulary
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Estradiol vaginal tablet
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Formulary
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- 10mg vaginal tablet
- Vagifem®
- Vagirux® (alternative)
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Sequential combined cyclical HRT patch (Evorel® Sequi)
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Formulary
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Tibolone
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Formulary
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Hormone replacement therapy |
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Ethinylestradiol |
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Raloxifene |
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Raloxifene Hydrochloride
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Formulary
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- For use on the advice of specialists in the prevention and treatment of osteoporosis where alternative treatments are inappropriate.
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NICE TA160: Raloxifene for the primary prevention of osteoporotic fragility fractures in postmenopausal women (Not Approved)
NICE TA161: Raloxifene and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women
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Oestrogen only tablets |
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Oestrogens and progestogen sequential combined therapy |
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Continuous combined therapy |
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Gonadomimetic |
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Selective oestrogen modulator |
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| 06.04.01.02 |
Progestogens |
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Norethisterone 5mg tablets
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First Choice
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Levonorgestrel (Mirena®)
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Formulary
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- Levonorgestrel 52mg in a T-shaped intra-uterine system.
- For idiopathic menorrhagia. Especially in women requiring (reversible) contraception. Also used for protection with endometrial hyperplasia during oestrogen replacement therapy. Lasts for up to 5 years - for use in accordance with agreed guidelines.
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Medroxyprogesterone Acetate
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Formulary
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Approved Medroxyprogesterone formulations include:
- 2.5mg, 5mg, and 10mg tablets (sometimes used as a progestogen component of HRT).
- 100mg & 200mg tablets (for use in malignant disease see section 8.3.2).
- 50mg in ml injection - see sections 7.3.2.2 for use of medroxyprogesterone acetate injection in contraception.
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Micronised progesterone (Utrogestan®)
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Formulary
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- 100mg oral capsules
- Approved for:
- adjunctive use with estrogen in post-menopausal women with an intact uterus, as hormone replacement therapy (HRT)
- Perimenopause (off-label)
- Premature ovarian insufficiency (off-label)
- Adolescents undergoing pubertal induction following chemotherapy (off-label)
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Progesterone
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Formulary
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- Approved formulations include:
- 200mg & 400mg pessaries (Cyclogest®)
- 25mg SC/IM injection (Lubion®)
- Approved for luteal support in patients who have had a previous failed biochemical pregnancy in a froxen embryo transfer (FET) cycle
- CD&TV for Luteal Phase support following IVF.
- Full course to be supplied by hospital
- CD&TV to support the pregnancies of women who have a history of miscarriage or premature labour as per NICE NG25: Preterm labour and birth.
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Ulipristal (Esmya®)
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 Restricted
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- 5mg tablets
- Approved for the pre-operative treatment of uterine fibroids for one 3 month course, as per its product licence.
- Approved for the medical treatment of uterine fibroids in women unsuitable for surgery, up to a maximum of four 3 month intermittent courses, as per its product licence and reviewed regularly.
- Contraindicated in women with underlying liver disorders.
- Requirements for liver function monitoring before, during, and after treatment
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MHRA Drug Safety Update (Feb 2021): Ulipristal acetate 5mg (Esmya): further restrictions due to risk of serious liver injury
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Key |
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Cytotoxic Drug
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Controlled Drug
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High Cost Medicine
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NHS England |
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Homecare |
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CCG |
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Traffic Light Status Information
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Description |
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Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment.
In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances.
For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing. |
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Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement.
The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber.
If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care. |
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Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs. |
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Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care. |
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NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria. |
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UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review. |
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NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status. |
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